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New pathology lab products and industry news from dozens of companies.

StatLab launches PiSmart slide printer

February 2024—StatLab announced the availability of its PiSmart thermal transfer slide printer for the automated printing of histology slides with patient information in three to five seconds. The slide printer connects with all on-market LIS systems or can be used as a standalone printer. The printer incorporates two hoppers for preloading different slide types. The single-slide manual load option allows users to bypass the hoppers when needed. PathSmart tracking software is included.

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Verichem bilirubin, urine chemistry reference materials

Verichem Laboratories Tru-Zero Bilirubin Standard

February 2024—Verichem Laboratories now offers its Tru-Zero Bilirubin Standard as part of the company’s line of liquid-stable and protein-based total and direct bilirubin clinical reference materials. The standard is intended to be treated as a patient specimen and features universal instrument compatibility. The concentration level for the total and direct bilirubin assays is 0.0 mg/dL. The product has an open-vial stability claim of five days and a shelf life of 14 months when stored at 2° to 8°C.

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Machaon offers updated aHUS genetic panel

February 2024—Machaon Diagnostics has updated its genetic panel for detecting atypical hemolytic uremic syndrome. The aHUS genetic panel 3.0 now includes two more genes, for a total of 22, associated with thrombotic microangiopathies, including aHUS, thrombotic thrombocytopenic purpura, C3 glomerulopathy, congenital B12 deficiency, and others. Turnaround time is one week.

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CLSI introduces country-based pricing model

February 2024—The Clinical and Laboratory Standards Institute has implemented new country-based pricing for countries that meet economic criteria set forth by the World Bank. Under this model, low- and lower-middle income countries receive a 90 percent discount off list prices and upper-middle income countries receive a 50 percent discount. The CLSI says that the pricing structure enables laboratories and clinicians around the world, regardless of resources, to more feasibly access its library of standards documents, training and support materials, and membership.

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Horiba launches next-gen HELO hematology solution

Horiba Medical HELO 2.0 high-throughput automated hematology platform

February 2024—Horiba Medical has launched the CE-IVDR–approved HELO 2.0 high-throughput automated hematology platform. The platform is composed of the Yumi­zen H1500 and H2500 high-throughput hematology analyzers, Yumizen T6000 automated conveyor, Yumizen P8000 middleware and expert validation station, and Yumizen SPS automatic slide maker. In addition, CellaVision digital cell morphology systems can be integrated with the P8000 middleware.

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Thermo Fisher, Aesku sign distribution agreement

February 2024—Thermo Fisher Scientific announced an exclusive distribution agreement with Aesku Group to market, sell, and support Aesku’s portfolio of FDA-cleared immunofluorescence products, automated instruments, and software in the United States. The agreement expands Thermo Fisher’s immunology product portfolio of Elia autoimmune diagnostics, ImmunoCap allergy diagnostics, and Phadia systems to include complementary reagents and systems from Aesku.

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Roche launches next-generation qPCR system

February 2024—Roche launched the LightCycler Pro system, designed and labeled for research and in vitro diagnostic workflows. Enhancements of this LightCycler system include a new vapor chamber for temperature uniformity across the block, new and improved software algorithms, and updated software and user interface. Users can develop their own tests or choose from a portfolio of more than 200 LightMix modular research assays and more than 60 LightMix CE-IVD assays from Roche subsidiary TIB Molbiol.

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CLSI releases jointly developed 2023 breakpoint implementation toolkit

January 2024—The Clinical and Laboratory Standards Institute, Association of Public Health Laboratories, American Society for Microbiology, the CAP, and Centers for Disease Control and Prevention have jointly developed a breakpoint implementation toolkit (BIT) to assist clinical laboratories in updating minimal inhibitory concentration breakpoints. The toolkit includes links to other resources that explain the rationale behind breakpoint updates, regulatory requirements for updating breakpoints, and detailed instructions for performing an AST breakpoint validation or verification. Manufacturers of AST systems can provide guidance on breakpoints used and clearance status with their systems.

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Tosoh G8 now connects to Sysmex XN-9000, XN-9100 systems

January 2024—Tosoh Bioscience has entered into an agreement with Sysmex America in which its HLC-723G8 automated glycohemoglobin analyzers can be connected to Sysmex XN-9000 and XN-9100 automated hematology systems in the United States, Latin America, and Canada. With this agreement, Tosoh says it aims to expand its HbA1c offering to the high-volume testing market and further automate hemoglobin A1c testing.

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Roche launches Elecsys HBeAg quant in CE markets

January 2024—Roche launched the Elecsys HBeAg quant, an immunoassay for the in vitro qualitative and quantitative determination of hepatitis B e antigen in human serum and plasma. In conjunction with other laboratory results and clinical information, HBeAg quantification may be used as an aid in the diagnosis and monitoring of patients with hepatitis B viral infection. It is for use on Cobas e analyzers in countries that accept the CE mark.

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Ad Astra QScout hematology analyzer gets 510(k) clearance

Ad Astra QScout hematology analyzer

January 2024—Ad Astra Diagnostics has received 510(k) clearance from the FDA for its QScout rapid-result hematology system. The analyzer provides point-of-care white blood cell counts and a neutrophil-to-lymphocyte ratio and differentiates the number and percent of five types of mature WBCs as well as immature granulocytes. To run the test, whole blood is added to a QScout rapid leukocyte differential test, which contains a dried reagent that stains cells. When the test is inserted in the QScout analyzer, an optical system takes images and an algorithm identifies the cells in real time. Results are displayed in about two minutes.

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LGC launches unmethylated, methylated ctDNA mutation mixes

December 2023—LGC Clinical Diagnostics has launched Seraseq unmethylated and methylated ctDNA mutation mixes for assay development, validation, and routine performance monitoring. Key features of the products include global methylation of CpG sites to support all CpG methylation assays and enzymatically fragmented ctDNA for low background noise and physiologically relevant fragment sizes. Methylation status is quantified using digital PCR assays and validated by targeted next-generation sequencing panels. The products are manufactured in GMP-compliant, ISO 13485-certified facilities.

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OGT, Intelliseq partner to advance clinical insight from NGS data

December 2023—OGT announced a partnership with Intelliseq, a genome informatics company and provider of next-generation sequencing analysis solutions. The collaboration combines OGT’s SureSeq NGS portfolio with Intelliseq’s iFlow engine, providing a sample-to-report workflow. Users will be able to easily interpret variant calls made by OGT’s NGS software via the Intelliseq iFlow engine.

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Cardiac Advance now compatible with Beckman instruments

Cardiac Advance

December 2023—Bio-Rad Laboratories has announced the expanded compatibility of its cardiac control, Cardiac Advance, to include Beckman Coulter instruments. The next-generation control is optimized with troponin I and troponin T targets near the limit of instrument detection and contains 10 of the most tested cardiac analytes, including troponin, CK-MB, BNP/proBNP, and myoglobin. Cardiac Advance is available in multiple formats, including the Liquicheck and InteliQ human serum-based controls.

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Quest, Scipher partner to expand testing for patients with RA

December 2023—Quest Diagnostics and Scipher Medicine announced a collaboration designed to expand patient access to diagnostic services for rheumatoid arthritis. Under a multiyear collaboration, Quest will provide RNA extraction and next-generation sequencing services for Scipher’s PrismRA test, a blood-based molecular signature response classifier aimed at predicting a patient’s response to TNF inhibitor therapy. Quest will enable specimen collection at about 7,300 patient access points and more than 2,100 patient service center locations, as well as courier services that transport patient specimens between Quest and Scipher laboratories and provider sites.

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Revvity study shows value of NGS in newborn screening

December 2023—A recent study by Revvity Omics has shown the clinical value of proactive, sequencing-based screening in apparently healthy newborns (Balciuniene J, et al. JAMA Netw Open. 2023;6[7]:e2326445). The objective of the study was to assess the clinical utility of genome sequencing versus a gene panel for a curated set of medically actionable pediatric-onset conditions in a large cohort of apparently healthy newborns and children tested at a clinical laboratory.

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Veracyte announces IVD agreement with Illumina

December 2023—Veracyte has entered into a multiyear agreement with Illumina to develop and offer some of its high-performing molecular tests as decentralized in vitro diagnostic tests on Illumina’s NextSeq 550D× next-generation sequencing instrument. The agreement is part of Veracyte’s expanded, multiplatform IVD approach, which will also include qPCR.

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FDA approves therapy for myelodysplastic syndromes

December 2023—The FDA has approved ivosidenib (Tibsovo, Servier Pharmaceuticals) for the treatment of adult patients with relapsed or refractory myelodysplastic syndromes with an isocitrate dehydrogenase-1 mutation as detected by an FDA-approved test. The agency also approved the Abbott RealTime IDH1 assay as a companion diagnostic for the selection of R/R MDS patients with an IDH1 mutation.

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FoundationOne CDx approved for capivasertib plus fulvestrant

December 2023—Foundation Medicine has received FDA approval for its FoundationOne CDx to be used as a companion diagnostic for capivasertib (Truqap, AstraZeneca) in combination with fulvestrant, which has been contemporaneously approved for the treatment of adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

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Verichem reference materials for serum and urine testing

Verichem Laboratories Urine Uric Acid Standard kit

November 2023—Verichem Laboratories announced the availability of its Urine Uric Acid Standard kit, Matrix Plus Cholesterol Reference kit, and a standalone, ultra-high Matrix Plus Cholesterol Reference level F for the calibration verification testing of cholesterol and urine and serum uric acid assays. The Urine Uric Acid Standard kit is a five-level kit with uric acid concentrations ranging from 1 to 101 mg/dL. The materials feature universal testing compatibility and are composed of a biosynthetic matrix with urine-like activity. Storage temperature is −15° to −25°C and Verichem says the product can tolerate up to 10 freeze-thaw cycles with no effect on accuracy or performance. Shelf life is 19 months.

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FDA clears Thermo Fisher chromogranin A assay

November 2023—Thermo Fisher Scientific announced FDA clearance of its Thermo Scientific Brahms CgA II Kryptor, an automated immunofluorescent assay for the quantitative determination of the concentration of chromogranin A in human serum. The biomarker is to be used in conjunction with other clinical methods as an aid in monitoring disease progression during the course of disease and treatment in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NET), grades 1 and 2.

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BioMérieux announces CE mark for Vidas TBI test

November 2023—BioMérieux announced it has received the CE mark for its Vidas TBI (GFAP, UCH-L1), a test to support the assessment of patients who have mild traumatic brain injury. The blood test measures the concentration of glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase-L1 (UCH-L1), two brain biomarkers that are released into the bloodstream during the first hour following a brain injury. It aims to fill a gap in patient screening methods by ruling out acute intracranial lesions and helping to determine if a CT scan is necessary.

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FDA approves Qiagen CDx for GIST

November 2023—Qiagen announced FDA approval of its Therascreen PDGFRA RGQ PCR kit, a companion diagnostic intended for use to aid clinicians in identifying patients with gastrointestinal stromal tumors (GIST) who may be eligible for treatment with avapritinib (Ayvakit, Blueprint Medicines). Ayvakit is approved in the United States for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. Qiagen says its kit is the first PDGFRA assay to receive FDA approval as a companion diagnostic.

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MMQCI releases BCR-ABL IS linearity panel

Maine Molecular Quality Controls Xpert BCR-ABL IS p210 Linearity Panel C207

October 2023—Now available from Maine Molecular Quality Controls is the Xpert BCR-ABL IS p210 Linearity Panel C207. It’s intended for use as an assayed external quality control to monitor the performance of the in vitro quantitative detection of BCR-ABL1 translocation mRNA e14a2/b3a2 transcripts and the ABL1 endogenous control mRNA transcript. It is designed to be used with the Xpert BCR-ABL Ultra assay on Cepheid GeneXpert instruments. Each kit comprises 12 bottles with two bottles of each international scale percent (%IS) value in 4 mL of synthetic BCR-ABL1 RNA transcript and synthetic ABL1 control gene RNA transcript suspended in a stabilizing matrix with a noninfectious solution of buffers and preservatives.

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FDA approves Bosulif for pediatric patients with CML

October 2023—The FDA approved bosutinib (Bosulif, Pfizer) for pediatric patients who are one year old and older with chronic phase Ph+ chronic myelogenous leukemia that is newly diagnosed or resistant or intolerant to prior therapy. Efficacy was evaluated in the BCHILD trial (NCT04258943), a multicenter, nonrandomized, open-label trial conducted to identify a recommended bosutinib dose in pediatric patients with newly diagnosed chronic phase Ph+ CML and resistant or intolerant Ph+ CML; estimate the safety, tolerability, and efficacy; and evaluate bosutinib pharmacokinetics in this patient population.

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Pillar Biosciences launches OncoReveal Core LBx NGS kit

October 2023—Pillar Biosciences announced the global launch of OncoReveal Core LBx, a research use only, liquid biopsy–based next-generation sequencing kit for pan-cancer tumor profiling. The panel interrogates 104 clinically relevant genes in one multiplex reaction, analyzes cfDNA present in plasma for genetic alterations in cancer, including assessment of micro­satellite instability, and can batch more than 20 clinical samples on a single Illumina NextSeq run. Mutation detection performance is as low as 0.1 percent.

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Wren Labs molecular Dx predicts patient response to PRRT

October 2023—Wren Laboratories launched its PRRT (peptide receptor radionuclide therapy) Predictor Quotient, or PPQ, a companion diagnostic to its NETest, a liquid-biopsy neuroendocrine tumor diagnostic. The test classifies patients as either a responder, a patient who will experience disease stabilization and have a longer time to disease progression (usually greater than 18 months after the end of PRRT treatment), or as a nonresponder, who will have a shorter time until the disease progresses (usually less than 12 months after the start of PRRT). According to a research paper published in April (Bodei L, et al. J Nucl Med. 2023;64[9]:1329–1330), the PPQ delivers 96 percent accuracy in determining patient response to PRRT.

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FDA clears Alinity h-series hematology system

October 2023—Abbott has received FDA clearance for its Alinity h-series hematology system, which includes the Alinity hq, an automated hematology analyzer, and Alinity hs, an integrated slide maker and stainer. The Alinity hq leverages multiangle polarized scatter separation (MAPPS) technology, which uses light scattering to distinguish cellular features and identify various blood cells, and processes up to 119 CBC results per hour. The system can be integrated into an existing core lab operation.

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Verichem enzyme calibration verifiers for liver function testing

Verichem Enzyme ER Verifier kit

October 2023—Verichem Laboratories offers multilevel enzyme calibration verification materials for liver function testing as part of its liquid-stable Enzyme ER Verifier kit. The kit contains the enzymes alanine aminotransferase (ALT/SGPT), alkaline phosphatase (AP/ALP), aspartate aminotransferase (AST/SGOT), gamma-glutamyl transferase (GGT/GGTP), lactate dehydrogenase (LD/LDH), amylase, cholinesterase, creatine phosphokinase, and lipase. Its proprietary formulation is designed to include at least one concentration for each enzyme within the normal range. The verifiers are intended to be treated as patient specimens and are compatible with wet chemistry systems from Abbott, Beckman Coulter, Roche, and Siemens Healthineers. Shelf life is 18 months.

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Sophia Genetics expands relationship with Gustave Roussy

October 2023—Sophia Genetics announced the expansion of its relationship with Gustave Roussy in which the cancer center will use the Sophia DDM digital analytics platform for all relevant samples, including those related to solid tumors and hematologic and hereditary cancers. Gustave Roussy, which has two campuses in France, began working with the cloud-native software company in 2017. Sophia Genetics is located in France and Boston.

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Illumina, Pillar Biosciences announce partnership

September 2023—Illumina and Pillar Biosciences announced a strategic partnership to make Pillar’s suite of oncology assays commercially available worldwide as part of Illumina’s portfolio of oncology products. The companies say the agreement will result in an unprecedented offering of complementary next-generation sequencing solutions that will enhance the efficiency, accuracy, and cost-effectiveness of oncology testing through advanced sequencing techniques.

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New book in Foundations in Diagnostic Pathology series

September 2023—Differential Diagnoses in Surgical Pathology: Tumors and their Mimickers, a new volume in the Foundations in Diagnostic Pathology series, has been published by Elsevier. The book, by Fadi W. Abdul Karim, MD, MEd, and Charles Sturgis, MD, aims to help readers quickly differentiate entities that have similar, overlapping histopathologic features and guide them through the decision-making process, providing a road map to the main differential diagnostic considerations that must be addressed when formulating a diagnosis. The book includes high-quality illustrations of similar-looking but distinct entities for side-by-side comparison in a user-friendly format with at-a-glance boxes and tables throughout the text, as well as selected references for further study. An enhanced ebook version is included with purchase.

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Comanche drug for preeclampsia gets fast track designation

September 2023—Comanche Biopharma announced it has received fast track designation from the FDA for its CBP-4888 as a novel small interfering ribonucleic acid (siRNA) therapy for preeclampsia. CBP-4888 is a fixed-dose combination of two chemically synthesized, lipid-conjugated siRNA duplex oligonucleotides, siRNA-2283 and siRNA-2519, targeting two soluble fms-like tyrosine kinase–1 (sFLT1) mRNA isoforms. Fast track is designed to facilitate the development and expedite the review process of drugs to treat serious conditions and fill an unmet medical need.

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American Registry of Pathology Press digital library

September 2023—The American Registry of Pathology Press digital library offers a fully searchable books platform with full-text versions of the books in ARP Press’ current series of fascicles, including the fourth and fifth series of the AFIP Atlases of Tumor and Non-tumor Pathology series. The site, arppress.org, offers pathologists robust searches across the series for images and text covering clinical features, differential diagnoses, immunohistochemistry, molecular biology, treatment, and prognosis.

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KSL Diagnostics opens transplant immunology laboratory

September 2023—KSL Diagnostics, Buffalo, NY, has opened a transplant immunology laboratory to serve the western New York region. KSL is the provider for Erie County Medical Center and Kaleida Health. ConnectLife, a community blood bank and federally designated not-for-profit organ procurement organization, uses KSL’s new lab and services Allegany, Cattaraugus, Chautauqua, Erie, Genesee, Niagara, Orleans, and Wyoming counties.

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GADx reintroduces IT-Leish test for visceral leishmaniasis

September 2023—Global Access Diagnostics announced the launch of IT-Leish, a UKCA-marked rapid test used for diagnosing visceral leishmaniasis. The company acquired the manufacturing rights for IT-Leish from Bio-Rad in September 2022 to prevent the test’s withdrawal from the market and support the World Health Organization’s strategic plan to eliminate life-threatening neglected tropical diseases.

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Verichem reference materials for electrolyte testing

Verichem Electrolyte Standard kit

September 2023—Verichem Laboratories offers a line of liquid-stable, multianalyte kits for the calibration verification of electrolyte assays for use with systems employing flame photometer, direct or indirect ion-selective electrode, or standard enzymatic/colorimetric testing methods. The Electrolyte Standard kit contains the analytes chloride, ionized calcium, lithium, potassium, and sodium and has a 21-month stability claim. The ISE Standard kit contains chloride, lithium, potassium, and sodium and has an 18-month stability claim. The Carbon Dioxide Standard kit and standalone CO2 Standard level F both have 15-month stability claims. All products are free of azides, glycols, surfactants, and other potentially interfering substances.

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FDA clears respiratory viral panel for BD Max

September 2023—BD announced FDA 510(k) clearance for its BD Respiratory Viral Panel for the BD Max system. It is a single molecular diagnostic combination test that uses a single nasal or nasopharyngeal swab sample to determine if a patient has SARS-CoV-2, influenza A, influenza B, or respiratory syncytial virus. Results are available in about two hours.

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Cole-Parmer ultra-low temp freezers

August 2023—Cole-Parmer introduced its North Sciences/Traceable TSi and TEC2 series ultra-low temperature freezers. The self-monitoring freezers are integrated with a Traceable data logger that is compatible with the TraceableLive cloud-based monitoring service, which provides audio and visual alerts via an Apple Watch, smartphone, tablet, or PC. The ULT freezers can reach temperatures down to −86°C and are ideal for the safe storage of samples and vaccines and compliant with Vaccines for Children storage requirements.

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OncoHost, BGN Technologies sign option agreement

August 2023—OncoHost has signed an option agreement with BGN Technologies, the technology transfer company of Ben-Gurion University of the Negev (Be’er Sheva, Israel), to receive a license for a novel biosensing technology called IcAR, or Immuno-checkpoint Artificial Reporter, developed by researchers from BGU. IcAR biosensing technology measures the binding functionality of PD-1 ligands, PD-L1 and PD-L2, to their receptor, PD-1. The researchers found that assessing the functionality of PD-1 ligands was an effective predictor of identifying who will positively respond to anti-PD-1 treatment.

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FBI approves Qiagen ForenSeq Mainstay workflow for NDIS

August 2023—Qiagen announced that the U.S. Federal Bureau of Investigation has approved its ForenSeq Mainstay workflow, allowing accredited forensic DNA laboratories to process DNA casework samples and search resulting profiles against the U.S. National DNA Index System CODIS database. The ForenSeq Mainstay workflow is composed of the high-throughput Verogen ForenSeq Mainstay kit, MiSeq FGx next-generation sequencing system, and ForenSeq Mainstay analysis module in the Universal Analysis software.

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Illumina launches DRAGEN 4.2

August 2023—Illumina launched the latest version of its DRAGEN software, version 4.2, for analyzing next-generation sequencing data. New features of the software include increased single nucleotide variant and structural variation calling accuracy powered by an enhanced machine learning model and multigenome graph, improvements in small copy number variation calling accuracy with joint SV/CNV calling, and the addition of four targeted callers for carrier screening—HBA 1/2, CYP21A2, RHD/RHCE, and LPA.

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Verichem calibration verification reference materials

August 2023—A multilevel set of liquid-stable clinical reference materials for use with ammonia and iron testing are available from Verichem Laboratories. The five-level standard kit, along with an optional, standalone ultra-high sixth level, is designed for the calibration verification of ammonia and iron assays on a range of automated clinical systems, including from Abbott Diagnostics, Beckman Coulter, Roche Diagnostics, and Siemens Healthineers. The materials are treated as patient specimens and free of glycols, surfactants, azides, and other interfering substances. Iron concentration levels of 10–1,000 μg/dL are verified using standard reference materials from the National Institute of Standards and Technology, and ammonia concentrations of 10–2000 μg/dL are verified using reagent-grade standards from the American Chemical Society. Shelf life is 24 months.

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FDA approves ARUP Labs AAV5 DetectCDx

August 2023—ARUP Laboratories announced that the FDA approved AAV5 DetectCDx as a companion diagnostic to aid in the selection of adult patients eligible for treatment with Roctavian (valoctocogene roxaparvovec-rvox). Roctavian, a gene therapy developed by BioMarin Pharmaceutical, received contemporaneous FDA approval for the treatment of adults with severe hemophilia A (congenital factor VIII deficiency with FVIII activity <1 IU/dL) without antibodies to adeno-associated virus serotype 5 (AAV5) detected by an FDA-approved test.

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LGC launches Seraseq 22q11 female-matched reference material

August 2023—LGC Clinical Diagnostics announced that its Trisomy 22q11 Female-Matched Reference Material is now included in its Seraseq noninvasive prenatal testing portfolio. It is a circulating cell-free DNA–like mixture of human genomic DNA (matched maternal and fetal) in a commutable matrix intended to be used as a reference material to monitor library preparation, sequencing, and detection performance. The material is processed to maintain the natural cell-free DNA size profiles of fetus and maternal DNA of approximately 170 base pairs.

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Bio-Rad launches second installment in QC workbook series

August 2023—Bio-Rad Laboratories has published the second workbook in a series that offers Professional Acknowledgement for Continuing Education credits. The second installment, titled “Laboratory Quality Control Materials,” focuses on identifying proper QC materials and using and handling them appropriately to help monitor QC testing procedures that produce high-quality patient results. Lab professionals can receive a certificate after successfully completing a short exam at the end of the workbook and earn 2.0 contact hours.

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LGC launches Accurun MS2 internal control

July 2023—LGC Clinical Diagnostics has launched the SeraCare Accurun MS2, a full-process internal control that can be used as a tool to monitor the process integrity of sample extraction and amplification of nucleic acid amplification–based assays. The product contains positive materials of intact MS2 bacteriophage, and the ready-to-use controls can be spiked into specimens that are going through DNA/RNA extraction.

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Bio-Rad launches bulk urine, CSF negative controls

July 2023—Bio-Rad Laboratories launched two Exact Diagnostics products, Bulk Urine Negative and Bulk CSF Negative controls. The bulk urine negative control is intended to be validated as an independent external quality run control to monitor the absence of adenovirus, BK virus, Candida auris, Chlamydia trachomatis, cytomegalovirus, John Cunningham virus, Mycoplasma genitalium, Neisseria gonorrhoeae, Trichomonas vaginalis, and Zika virus in various molecular assays. The bulk CSF negative control is an independent external quality run control intended to monitor the absence of Anaplasma phagocytophilum, Babesia microti, Bartonella quintana, Borrelia burgdorferi, Ehrlichia chaffeensis, enterovirus, herpes simplex virus 1 and 2, and varicella-zoster virus in various molecular assays.

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Siemens to distribute Scopio digital cell morphology platforms

July 2023—Siemens Healthineers has entered into an agreement with Scopio Labs to distribute the Scopio X100 and Scopio X100HT. These imaging platforms will complement Siemens hematology systems, including the Atellica Hema 570 and Hema 580 analyzers, to offer laboratories high-resolution, full-field viewing for peripheral blood specimens and artificial intelligence–based morphological analysis with remote viewing capabilities.

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OGT partners with Applied Spectral Imaging

July 2023—OGT, a Sysmex Group company, announced a commercial partnership with Applied Spectral Imaging. The agreement will grant OGT rights to market ASI’s proprietary cytogenetic imaging and analysis solutions in Great Britain, establishing a strategic partnership that the companies say combines the strengths of OGT’s CytoCell FISH portfolio with ASI’s imaging and analysis capabilities.

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Verichem offers free data reduction reports

July 2023—Verichem Laboratories now offers its customers free access to its Web-based and online calibration verification data reduction and test-reporting programs. Designed for use with the company’s clinical reference materials, these programs and services provide the necessary statistical data and test reports to satisfy CLIA requirements for the calibration verification of clinical assays. Users can register online with a password, log in, and then enter and submit data; there is no software to download. Reports are generated instantly in a PDF format and are ready to review, sign off, and file. Final reports can include clinical system test accuracy, linearity, precision, precision with peer comparison, and other supplemental study data. Technical support is available via phone to answer questions or troubleshoot.

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BD launches FacsDuet Premium system

July 2023—BD announced the worldwide commercial launch of its BD FacsDuet Premium system. The automated instrument prepares samples for in vitro diagnostic and user-defined tests, including cocktailing, washing, and centrifuging, and then automatically transfers samples to the integrated BD FacsLyric clinical flow cytometry system, enabling a walkaway workflow solution.

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FDA clears Immuno Concepts IgG Anti-nDNA test system

July 2023—Immuno Concepts announced FDA 510(k) clearance of its IgG Anti-nDNA fluorescent test system for use with the company’s Image Navigator system. The test is for in vitro diagnostic use for qualitative detection and semiquantitation of anti-nDNA antibodies of the IgG class in human serum to aid in diagnosing systemic lupus erythematosus in conjunction with other clinical and laboratory findings.

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Safety-Spec launches gross room trays

July 2023—Safety-Spec launched its Safety-Spec Gross Room Tray. The reusable trays are designed to ensure tissue specimens are easily accessible, properly labeled, and neatly organized. Each tray is constructed of high-quality, dense, closed-cell foam, providing a lightweight, flexible, nonbreakable, and washable tray that can accommodate up to four specimen bottles, eight cassettes (two per specimen), and specimen-related paperwork. Trays are available in packs of 30, 60, 90, and 120, with red, yellow, green, blue, purple, and white trays in each pack.

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RMT introduces RmtHealthCheck

July 2023—Remote Medical Technologies introduced RmtHealthCheck, a new feature of the company’s RmtConnectPlus real-time telepathology solution. It notifies users via email of network disruptions that could impede system access. Once the issue is corrected, the system will email users that the network connection has been restored. Third-party software is not required for use.

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Bruker launches TimsTOF Ultra mass spectrometer

July 2023—Bruker Corp. launched its TimsTOF Ultra mass spectrometer at the American Society for Mass Spectrometry annual conference, June 4–8, in Houston, Tex. TimsTOF Ultra can identify, with 125 pg of material, more than 5,500 protein groups in 22 minutes via a collision cross section–enabled TIMScore and TIMS DIA-NN 4D-Proteomics or Spectronaut 18 software. Its new Captive­Spray Ultra ion source with vortex flow enhances ion formation across nanoflow liquid chromatography gradients. The platform has a parallel accumulation–serial fragmentation (PASEF) scan speed of up to 300 Hz for tandem mass spectrometry.

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Danish National Genome Center selects Qiagen’s QCI Interpret

July 2023—Qiagen announced that its variant interpretation and reporting software, Qiagen Clinical Insight (QCI) Interpret, was chosen by the Danish National Genome Center to provide interpretation of oncology results generated from whole genome sequencing data. The initiative is part of a larger personalized medicine strategy that aims to provide WGS as the standard of care for relevant patient groups throughout Denmark.

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BioMérieux launches BioFire Fireworks software

June 2023—BioMérieux has launched BioFire Fireworks, an integrated software solution for BioFire systems that is part of the company’s Vision Suite data-management product line. Fireworks provides access to a centralized data-management Web portal, giving users insights and analytics into BioFire system performance, utilization, pathogen surveillance, and workflow management. The software was designed, developed, and implemented following industry standards and regulations and gives customers complete control over their data.  

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Worthington Biochemical product catalog

June 2023—Worthington Biochemical announced that the 23rd edition of its enzyme and biochemical catalog is now available in print and digital formats. The catalog covers a wide array of products for life science applications including immunology, cell biology, molecular biology, research, biochemistry, and bioprocessing. It features Worthington Animal Free enzymes for preclinical, bioprocessing, and biopharma applications produced under ISO 9001–certified and GMP guidelines and contains a number of references, including technical enzyme selection tools, product specifications and application tables, related products at a glance, and product listings by application.

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SeraCare releases solid tumor CNV reference material

June 2023—LGC SeraCare has developed a comprehensive solid tumor copy number variation reference material in a formalin-fixed, paraffin-embedded format. The Seraseq FFPE Solid Tumor CNV RM includes 12 clinically relevant CNVs associated with solid tumors. Amplifications of these target genes are quantitated by digital PCR, blended in a well-characterized genomic background, and validated with next-generation sequencing. One 10-μm FFPE curl is provided per vial, and the product is designed to give a minimum yield of 100 ng per curl.  

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Siemens launches Atellica Hema analyzers

June 2023—Siemens Healthineers launched two solutions for high-volume hematology testing, the Atellica Hema 570 analyzer and Atellica Hema 580 analyzer. Both have a throughput rate of up to 120 tests per hour. The Atellica Hema 570 measures 43 cell parameters and an additional 12 parameters are available on the Hema 580, including immature red blood cell indicators relevant to certain patient populations and an optical-based platelet count that reduces analytical interfer­ences found in other detection technologies. Their user-friendly designs aim to reduce daily maintenance while supporting rapid reagent changes.  

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Momentum Consulting offers plan for lab optimization

June 2023—Momentum Consulting has kicked off its laboratory optimization program for CLIA labs that are emerging from the COVID pandemic with broad or specific needs. The plan covers maximizing existing resources in a laboratory for output in areas such as specimen processing, workflow, new test menus, quality management, billing and collection, sales revenue, and more. Momentum has a team of subject matter experts in these fields to help laboratories improve their productivity.  

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Early Lyme disease detection

June 2023—Zeus Scientific has introduced the Zeus Borrelia Modified Two-Tiered Testing (MTTT) algorithm, an FDA-cleared all-ELISA algorithm designed to improve the detection of early Lyme disease by up to 30 percent compared with the standard two-tiered testing algorithm. It replaces a second-tier immunoblot with a second Zeus ELISA methodology to provide additional supportive evidence of infection. The company offers two algorithms: Zeus Borrelia MTTT-1 uses the Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM test system as a first-tier test followed by the Zeus B. burgdorferi IgG/IgM test system; Zeus Borrelia MTTT-2 uses the Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM test system as a first-tier test followed by the Zeus B. burgdorferi IgG test system and Zeus B. burgdorferi IgM test system.  

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Visiopharm launches Ki-67 algorithm

June 2023—Visiopharm announced the launch of a next-generation Ki-67 algorithm designed to automate the scoring of Ki-67 slides. Tumor nuclei are counted based on their Ki-67 expression and the resulting proliferation index for the whole tumor area is calculated. The algorithm has been cleared under the European Union in vitro diagnostic regulation and is for research use only in the United States.  

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BD gets clearance for MRSA diagnostics AI software

June 2023—BD received FDA 510(k) clearance for the BD Kiestra methicillin-resistant Staphylococcus aureus imaging application, which uses artificial intelligence to automate the task of inspecting Petri dishes to determine if there is bacterial growth. The application can evaluate single specimens or group together a large volume of plates with nonsignificant growth for batch review and release negative results. It uses AI algorithms to look for specific culture characteristics on the BBL Chromagar MRSA II plate. Based on that information and analysis by BD Synapsys informatics, plate images are automatically organized and sorted into meaningful worklists, the company says.  

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Verichem calibration verifiers for cholinesterase testing

June 2023—Verichem Laboratories offers multilevel calibration verification materials for cholinesterase activity as part of its liquid-stable and ready-to-use Enzyme ER Verifier kit. The verifiers are designed to include at least one concentration level of enzyme activity within the normal range and intended to be treated as patient specimens. The material’s protein balance, pH, and ion content are constant across concentration levels. The kit material also contains multilevel assigned activities for alanine aminotransferase, alkaline phosphatase, alpha-amylase, aspartate aminotransferase, creatine phosphokinase, gamma-glutamyl transferase, lactate dehydrogenase, and lipase. Each kit has 5 mL of material for each of the six levels and a shelf-life and open-vial stability of 18 months.  

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Trane Technologies acquires Helmer Scientific

June 2023—Trane Technologies has acquired Helmer Scientific. Trane says the acquisition will broaden its capabilities in precision temperature control and its existing portfolio of life science solutions under the Farrar brand. Trane will leverage its operating system and expertise in sustainability, services, worldwide distribution, and commercialization to accelerate Helmer’s continued growth.  

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FDA clears Panther Fusion SARS-CoV-2, flu, RSV assay

June 2023—Hologic announced the FDA has granted 510(k) clearance for its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. This molecular diagnostic test, previously under EUA, detects and differentiates SARS-CoV-2, influenza A and B, and respiratory syncytial virus. It runs on the Panther Fusion system, which provides initial results in about three hours and can process more than 1,000 tests in 24 hours.  

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Labcorp gets exclusive license for Proteomedix prostate cancer test

June 2023—Proteomedix (Schlieren, Switzerland) announced an exclusive license agreement in which Labcorp will develop and commercialize its Proclarix prostate specific antigen test in the United States. Proclarix is performed using the same blood sample as a PSA test and is designed to help determine the risk of clinically significant prostate cancer for men who have an elevated total PSA and a digital rectal examination finding that indicates elevated prostate volume but who are not suspected of having cancer.  

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Quansys Biosciences bovine-specific ELISAs

June 2023—Quansys Biosciences has developed Q-Plex Bovine Cytokine Panel 1 (5-plex), an ELISA kit that can measure five levels of bovine and African water buffalo cytokines in plasma, serum, and cell culture supernatants. Each kit contains a 96-well plate featuring the relevant biomarker panel in each well and all reagents required to perform testing.  

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Randox introduces PSA and BNP control

June 2023—Randox Labs has released two new products, a prostate-specific antigen and brain natriuretic peptide control. The liquid-frozen PSA is manufactured using human serum and has an open-vial stability of 30 days at 2°–8°C and a shelf life of one year from the date of manufacture. The control is optimized for use with Roche systems but is also suitable for use across a variety of other platforms, the company says.  

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Sarstedt launches NFT urine collection system

May 2023—Sarstedt’s new Needle-Free Transfer Urine Collection System is a closed urine collection system for needle-free transfer of urine from the needle-free cup or urine collection container to a Urine Monovette. The cup and collection container feature an integrated transfer unit with a pierceable membrane. After collecting a sample with the Urine Monovette, the membrane reseals immediately, ensuring hygienic and repeatable sample collection with no risk of accidental needle sticks. A 100-mL urine cup and 3-L urine container are available.

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Illumina launches Connected Insights software

May 2023—Illumina announced the release of Connected Insights, a cloud-based software for tertiary analysis of clinical next-generation sequencing data. The software enables labs to connect to a network of more than 45 third-party knowledge sources that provide digital directories for precision oncology, illustrating connections between cancer variants and therapies, citing evidence, and aiding analysis of complex cancer genomic profiles. It can also link users to regional guidelines, clinical trial databases, drug labels, and a private collection of data from previous cases within a customer’s laboratory. As the use of clinical NGS testing grows, Illumina says it will expand the software’s capabilities across other disease areas.  

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QuidelOrtho gets de novo authorization for Sofia 2 SARS Antigen+ FIA

May 2023—QuidelOrtho Corp. has been granted a de novo request from the FDA for its new Sofia 2 SARS Antigen+ FIA, a lateral flow immunofluorescent assay that is used with the Sofia 2 fluorescent immunoassay analyzer. It is intended for the qualitative detection of the nucleocapsid protein antigen of SARS-CoV-2 in direct anterior nasal swab specimens from people with signs and symptoms of upper respiratory infection when serial testing is started within six days of symptom onset. The Sofia 2 analyzer provides a result in 10 minutes.

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Sysmex Inostics, Genomic Testing Cooperative partnership

May 2023—Sysmex Inostics and Genomic Testing Cooperative formed a strategic partnership for Sysmex Inostics to commercialize GTC’s tissue and liquid biopsy solid tumors and hematology assay services, including Solid Tumor Profile Plus, Liquid Trace Solid Tumor Profile, Liquid Trace Hematology Profile, and Hematology Profile Plus assay services, to biopharma customers. The partnership brings together GTC’s proprietary genomic databases, technology in artificial intelligence, and DNA and RNA next-generation sequencing profiling with Sysmex Inostics’ worldwide commercial capabilities in biopharma therapeutic development and its Plasma-Safe-SeqS technology.

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Tempus gets FDA approval for xT CDx

May 2023—Tempus announced that the FDA has approved the company’s premarket approval application for its companion diagnostic test, xT CDx, to identify patients who may benefit from treatment with the targeted therapies listed in the product’s indications for use. It is a qualitative next-generation sequencing–based in vitro diagnostic device for use in the detection of single nucleotide variants, multi-nucleotide variants, and insertion and deletion alterations in 648 genes and includes the evaluation of microsatellite instability.

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FDA expands approval for Ventana PD-L1 assay

May 2023—Roche announced FDA approval of the Ventana PD-L1 (SP263) assay as a companion diagnostic to identify patients with locally advanced and metastatic non-small cell lung cancer eligible for treatment with Libtayo (cemiplimab-rwlc), a PD-1 inhibitor therapy developed by Regeneron. Libtayo’s approval is based on results of the phase three EMPOWER-Lung 1 study. The Opti­View DAB IHC detection kit is used for staining on a BenchMark Ultra instrument.

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Verichem calibration verifiers, reference materials

May 2023—Verichem Laboratories now offers multilevel calibration verification materials for amylase and lipase activity as part of its liquid-stable, ready-to-use Enzyme ER Verifier kit. The product is for use on automated chemistry systems and has a shelf life of 18 months. The kit contains one 5-mL dropper vial for each of the six levels.

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Maine Molecular releases SpotFire RSP controls

May 2023—Maine Molecular Quality Controls has released SpotFire RSP positive and RSP negative controls. The quality controls are for use in monitoring the performance of in vitro laboratory nucleic acid testing for the qualitative detection of Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Mycoplasma pneumoniae, adenovirus, seasonal coronavirus, SARS-CoV-2, human metapneumovirus, human rhinovirus/enterovirus, influenza A subtypes H1-2009 and H3, influenza B, parainfluenza virus, and RSV.

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Laboratory billing services provider

April 2023—Laboratory Billings is a revenue cycle management firm that aims to help laboratories achieve a higher first-pass claims rate and reduce accounts receivable. The company offers medical billing services to clinical and reference laboratories and shares real-time analytics about the revenue cycle. “We help laboratories become financially resilient and reduce the complexities in the administrative workflows,” according to a company statement. “Our billing and coding experts possess in-depth understanding of the revenue cycle management.” More information about the company is available at https://laboratorybillings.com.  

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FDA clears POC instrument for fentanyl testing

April 2023—Shenzhen Superbio Technology has received FDA clearance for the Ryan immunofluorescence analyzer, a point-of-care instrument for in vitro diagnostic use only. Carolina Liquid Chemistries Corp. will distribute the analyzer and fentanyl urine detection kit in partnership with Bioeasy USA. The fentanyl detection kit is intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1 ng/mL. It is intended for use with the Ryan analyzer, which provides results in less than six minutes.  

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FDA clears Simplexa COVID-19, flu A/B assay

April 2023—DiaSorin has received FDA 510(k) clearance for its Simplexa COVID-19 and Flu A/B Direct assay. The test is a real-time RT-PCR assay that detects and differentiates influenza A, influenza B, and SARS-CoV-2 viruses and is performed using nasopharyngeal swab samples. Results are available in a little more than an hour on the Liaison MDX instrument.  

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BioGx Candida auris PCR assay adoption accelerates

April 2023—BioGx announced accelerated adoption of its high-performance Sample-Ready PCR assay for the detection of Candida auris. A complete PCR mix is provided in a single lyophilized tube format to be validated by laboratories on a variety of real-time PCR instruments, including the BD Max, Thermo Fisher QuantStudio, Bio-Rad CFX Touch, and BioGx Pixl platform. The company says its assay has been successfully validated and implemented by public health laboratories and hospitals in several states.  

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BD introduces Rhapsody HT Xpress system

April 2023—BD introduced the BD Rhapsody HT Xpress system for single-cell multiomics analysis. The system enables users to isolate, barcode, and analyze single cells at a high sample throughput—up to eight times more cells, BD says, than prior versions of its single-cell analyzers. Users can analyze multiple samples and different cell sizes and types, such as stem cells or cancer cells, at the same time.

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Quest unveils transplant diagnostic services

April 2023—Quest Diagnostics unveiled Quest Advanced Specialized Transplant Services, designed to expand access to laboratory tests for transplanting solid organ, human cells, and tissue. Quest says its new offering features a menu of more than 170 specialized transplant and infectious disease tests, longitudinal trends analysis of test results in the electronic medical record, and support services that include medical consultation. Patients can access Quest’s network of 2,100 patient service centers and 5,000 mobile and at-home phlebotomists to support patient-compliant pre- and post-transplant testing. The services are available to recipients and living donors across the United States, excluding Alaska and Hawaii.  

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Visby gets FDA clearance, CLIA waiver for sexual health test

April 2023—Visby Medical has received 510(k) clearance and was granted a CLIA waiver from the FDA for its second-generation Sexual Health test. The point-of-care test uses PCR technology to detect sexually transmitted infections caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Visby says the new device features improvements in workflow, manufacturability, and reliability. Test accuracy is about 97 percent and results are available in less than 30 minutes.  

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FDA clears Leica Biosystems MMR antibody panel

April 2023—Leica Biosystems announced FDA 510(k) clearance of the Bond mismatch repair antibody panel for use in screening patients who have colorectal cancer for the identification of Lynch syndrome. The panel is for in vitro diagnostic use on Leica’s Bond-III and Bond-Max immunohistochemistry automated instruments. Turnaround time is 2.5 hours on the Bond-III and about 3.5 hours on the Bond-Max.  

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Qiagen, Servier to develop CDx for acute myeloid leukemia drug

April 2023—Qiagen has entered into a strategic partnership with Servier to develop a companion diagnostic test for Tibsovo (ivosidenib), an isocitrate dehydrogenase-1 inhibitor indicated for the treatment of acute myeloid leukemia. Under the agreement, Qiagen will develop and validate a real-time in vitro PCR test that can be used to detect IDH1 gene mutations in patients with AML in whole blood and bone marrow aspirates. The companion diagnostic will run on Qiagen’s Rotor-Gene Q MDx instrument.  

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Enzo Biochem to sell clinical lab to Labcorp

April 2024—Enzo Biochem announced it has entered into an agreement in which Labcorp will acquire the assets of Enzo’s clinical laboratory division, Enzo Clinical Labs. Labcorp said the acquistion will bolster its commitment to the New York tristate health care communities. Completion of the sale is contingent on approval by Enzo’s shareholders and other customary closing conditions.  

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Verichem Matrix Plus chemistry reference materials

April 2024—Verichem Laboratories liquid-stable Matrix Plus chemistry reference materials for the calibration verification of wet chemistry assays are now available. The multilevel kit, along with an optional and standalone level F, supports overall system quality control and CLIA compliance. The six-level set of materials contains seven individual chemistry analyte components covering 48 separate and individual concentration levels.  

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Verichem reference materials for triglyceride assays

April 2023—Verichem Laboratories released ready-to-use reference materials for use with calibration verification testing of triglyceride assays. The product is available in a five-level standard kit and an optional, standalone, ultra-high sixth level, with levels ranging from 10 to 1,250 mg/dL. Tricglyceride values are established by gravimetric weight of glycerol expressed as triolein.  

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Qiagen, Sophia partner to offer NGS solutions

March 2023—Qiagen has launched its QIAseq Platform Partnership program and a partnership with Sophia Genetics that will bring together QIAseq reagent technology for next-generation sequencing with the Sophia DDM digital analytics platform. The Platform Partnership program aims to enhance the use and compatibility of QIAseq NGS kits to support secondary analysis and tertiary interpretation workflows offered by other digital data-sharing and analytics companies. The kits are designed for use with any sequencer.  

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Verichem Enzyme ER Calibration Verifier kit

March 2023—Verichem Laboratories’ ready-to-use Enzyme ER Calibration Verifier kit is now available. The materials are designed for the calibration verification of enzyme assays on wet chemistry testing systems and contain nine clinical enzyme components covering 54 individual activity levels. The enzyme components within the materials include amylase, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, cholinesterase, creatine phosphokinase, gamma glutamyltransferase, lactate dehydrogenase, and lipase. The materials are intended to be treated as patient specimens and have a shelf life of 18 months.  

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AscencioDx COVID-19 test, molecular detector get EUA

March 2023—Anavasi Diagnostics announced FDA emergency use authorization for its Ascencio­Dx COVID-19 test and AscencioDx molecular detector for use in POC settings operating under a CLIA certificate of waiver, certificate of compliance, or certificate of accreditation. The system uses reverse transcription loop-mediated isothermal amplification for the qualitative detection of RNA from the COVID-19 virus in samples that are heated and illuminated via fluorescence signals in a reaction tube placed within the detector. Results are available in as few as 20 minutes. The detector is reusable for at least 3,000 test cycles, the company says, and is powered by a 12-volt adapter.  

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Globe Scientific introduces Globe/Euromex microscopes

March 2023—Globe Scientific has introduced a line of Globe/Euromex microscopes and microscope accessories. The line is composed of 24 CE-certified stereoscopic, compound, and inverted binocular and trinocular microscopes and 12 microscope accessories. Customers can access several support tools, including a microscope selection guide and Euromex Academy, which includes online video tutorials, user manuals, educational blogs, and more.  

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LGC launches BRCA1/2 reference materials

March 2023—LGC Clinical Diagnostics has launched the Seraseq gDNA BRCA1/2 LGR Somatic Mutation Mix and Seraseq gDNA BRCA1/2 LGR Inherited Mutation Mix. The products are intended for use as quality reference materials in developing, validating, and evaluating the routine performance of laboratory tests and are for research use only.  

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PerkinElmer debuts NGS workstation

March 2023—PerkinElmer debuted its Zephyr G3 NGS iQ workstation at the Society for Laboratory Automation and Screening conference in San Diego, Feb. 25–March 1. The system enables the automated construction of up to 96 NGS libraries and is composed of a high-performing liquid handler, integrated thermocycler, robotic arm, and deck accessories and peripherals. The workstation is available with an optional cloud-based software to further simplify creating and editing NGS protocols, the company says, by using a single pane of glass interface and developing methods from scientific intent rather than code.

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FDA expands approval of BD Onclarity HPV assay

March 2023—BD announced FDA market approval for the Onclarity HPV assay to be used with the Hologic ThinPrep Pap test. The Onclarity HPV assay detects and identifies 14 high-risk human papillomavirus types in a single analysis. The assay reports genotypes 16, 18, 31, 45, 51, 52, 33/58, 35/39/68, and 56/59/66, and has FDA approval for use in vaccinated women.  

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Flagship, Genomenon partnership

March 2023—Flagship Biosciences announced a partnership with Genomenon in which Genomenon’s Mastermind knowledge base will provide disease-specific genomic data sets to enrich Flagship’s genomic profiling services. The partnership aims to accelerate biomarker discovery and companion diagnostics development solutions and improve patient stratification for clinical trials and treatment selection.  

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Agilent releases on-deck thermal cycler for Bravo NGS platform

March 2023—Agilent Technologies released an on-deck thermal cycler that integrates with the company’s Bravo NGS automated liquid handling platform. The optional acces­sory enables the Bravo platform to provide thermal cycling as part of an automated protocol and extends walkaway time. The setup is beneficial, the company says, for applications such as library preparation and target enrichment steps in next-generation sequencing workflows, end-point PCR, and cell-based applications.  

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Bio-Rad launches real-time PCR system

March 2023—Bio-Rad launched its CFX Opus Deepwell Dx real-time PCR system, an open platform for developing in vitro diagnostic assays. The system multiplexes up to five targets and allows reaction volumes up to 125 µL in a 96-well format for quantitative PCR diagnostic assays. CFX Maestro Dx SE software provides data management and analysis tools.  

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BioMérieux Vidas Kube gets CE mark

January 2023—BioMérieux announced the CE marking of its Vidas Kube, a next-generation automated immunoassay system for the company’s Vidas range. The system features a stackable and modular benchtop design and is compatible with the existing routine test menu covering emergency and critical care, immunochemistry, and infectious diseases. The commercial launch is planned in selected countries at the beginning of the year, extending gradually to the rest of the world during the second quarter.

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Roche launches antibody to identify PRAME protein expression

January 2023—Roche has launched its Anti-PRAME (EPR20330) Rabbit Monoclonal Primary Antibody to identify PRAME protein expression in tissue samples from patients who are suspected of having melanoma. Studies suggest that the detection of PRAME expression by immunohistochemistry complements findings from routinely used tests and enables more informed clinical decisions and improved patient outcomes, according to a company press release.  

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General Data launches LaserTrack Flex

January 2023—General Data Healthcare launched its LaserTrack Flex cassette printer. The Flex has a footprint of 13” L × 19” W and a capacity that starts at 480 cassettes, with each magazine holding 80 cassettes; it can be upgraded to hold up to 800 cassettes. The standard configuration prints on the face of the cassette and can be upgraded to also print on one or both sides. Cassettes can be loaded on the right or left side of the printer.

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EKF handheld hemoglobin analyzer with POC connectivity

January 2023—EKF Diagnostics’ DiaSpect handheld hemoglobin analyzer now connects securely to EKF Link, the company’s point-of-care middleware. DiaSpect is also now equipped with Bluetooth and internal storage for 4,000 tests and QC results, as well as the capability to provide a calculated hematocrit value alongside the hemoglobin result. Test results are stored and accessed securely on a centralized platform.

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SeraCare BRCA NGS reference material

January 2023—LGC SeraCare announced the availability of its Seraseq FFPE BRCA1/2 LGR Reference Material intended for use with next-generation sequencing assays or amplified nucleic-acid–based methods that identify somatic and germline variants in BRCA1 and BRCA2 genes. The reference material contains 20 DNA variants in the genomic background of GM24385. One 10-μm formalin-fixed, paraffin-embedded curl is provided per vial.

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Thermo Fisher launches TrueMark infectious disease panels

January 2023—Thermo Fisher Scientific launched its TrueMark Infectious Disease Research Panels. The analytically sensitive, duplexed TaqMan assays are performed on pre-spotted and dried-down plates that include microorganism‑specific pathogens, using real‑time PCR techniques, which enables rapid and accurate detection for investigating microorganisms that cause respiratory, vaginal, urinary, gastrointestinal, and sexually transmitted diseases. The predefined and customizable panel options allow researchers to choose from more than 90 different bacterial and viral strain assays to generate results within four hours of taking the samples. Testing can be done from nasopharyngeal swabs or nasopharyngeal aspirate; vaginal, genital, and lesion swabs; or urine samples.

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Bio-Rad launches blood screening controls in Europe

January 2023—Bio-Rad Laboratories has announced that Exact Diagnostics HBV, HCV, and HIV-1 screen controls are available in Europe. The controls are designed to monitor the performance of blood donor screening assays and are calibrated against the Third WHO International Standard for HBV (NIBSC code 10/264) and HIV-1 (10/152) and the Fourth WHO International Standard for HCV (06/102). The products are made of whole viruses in a citrate plasma matrix to ensure lot-to-lot reproducibility, have an 18-month shelf life from date of manufacture when stored at −20°C or below, and are stable for 24 hours when stored at 2° to 8°C.

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Spot Imaging introduces sample-tracking solutions

January 2023—Spot Imaging has introduced three instruments for sample tracking and storage designed to address staffing shortages and storage inefficiencies. BlocDoc automatically captures images of cut blocks and raw slides for electronic sharing and tracking. The PathTracker scans cassettes and slide transport containers in bulk, scanning 150 cassettes in less than 25 seconds, and uploads the information to the PathTracker and laboratory information system. PathArchiv is a file-room sample management system for blocks and slides that can trace samples by case, loan status, location, or age.

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Roche announces collaboration with Pfizer

January 2023—Roche has entered into a collaboration with Pfizer to help patients access resources and locate information about COVID-19 testing, available treatment options, high-risk factors that increase the chance of progressing to severe COVID-19, and ways to seek timely care. People can learn why early testing is important at symptom onset, which health conditions increase the risk of progressing to severe COVID-19, and what treatment options are available on covid19knowmore.com, a Pfizer website. The Pilot COVID-19 At-Home Test, distributed in the U.S. by Roche and manufactured by SD Biosensor, will include a QR code that directs people to the website.

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FDA authorizes PerkinElmer Eonis kit for SMA screening in newborns

January 2023—PerkinElmer announced that the FDA has authorized the marketing of its Eonis SCID-SMA assay kit for in vitro diagnostic use by certified laboratories for the detection of spinal muscular atrophy and severe combined immunodeficiency in newborns. This is the first FDA-authorized assay for SMA screening in newborns in the United States, the company says, and is part of the company’s Eonis platform. The Eonis platform is a robust, flexible system that uses real-time PCR technology to screen for SMA and SCID using a single dried blood spot sample.

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QuidelOrtho, Runda form joint venture to develop assays

January 2023—QuidelOrtho will form a joint venture between Ortho Clinical Diagnostics Trading, a subsidiary of QuidelOrtho, and Shanghai Medconn Biotechnology, a subsidiary of Shanghai Runda Medical Technology, to develop and manufacture assays in China for QuidelOrtho’s Vitros platform. Following a successful assay pilot program, the companies expect to begin developing a broader set of assays early this year in parallel with building out the joint venture organization in the Shanghai and Beijing areas.

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Thermo Fisher liquid biopsy assays

February 2023—Thermo Fisher Scientific has introduced more than 50 Absolute Q liquid biopsy assays for research use. The wet lab verified liquid biopsy assays provide highly sensitive, specific nucleic acid quantification, enabling single nucleotide polymorphisms detection down to 0.1 percent variant allele frequency.  

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IMV awards Werfen five ServiceTrak awards

February 2023—Werfen has received five 2022 IMV Service­Trak clinical laboratory awards in two categories. The company received best system performance and best service awards in the coagulation analyzers category, and awards for best customer satisfaction, best system performance, and best service in the blood gas category. This is the fourth consecutive year Werfen has been recognized in coagulation and the second time it has received all three awards in the blood gas category.  

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Vistapath introduces Sentinel platform

February 2023—Vistapath has introduced its flagship product, the Sentinel pathology processing platform. The platform uses machine vision combined with artificial intelligence to assess specimens and create a gross report in a few seconds. It consists of the Sentinel module, which measures 17 in. W × 12 in. D × 15 in. H, and the touchscreen, which measures 15 in. W × 8 in. D × 11 in. H.  

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Agilent, Akoya to develop multiplex IHC solutions

February 2023—Agilent Technologies announced a partnership with Akoya Biosciences to develop chromogenic and immunofluorescent multiplex assays that include spatial analysis for biopharma companies developing precision cancer therapeutics. The agreement aims to deliver an end-to-end multiplex solution integrating Agilent’s Dako Omnis staining instrument and Akoya’s PhenoImager HT imaging platform.  

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Qiagen launches EZ2 Connect MDx for diagnostic use

February 2022—Qiagen has launched its EZ2 Connect MDx for use in diagnostic laboratories. The platform enables labs to purify DNA and RNA from up to 24 samples at the same time in as few as 30 minutes and uses magnetic-bead technology to extract nucleic acids from blood plasma, serum, stool, and other sample types. The benchtop instrument automatically pierces sealed cartridges, heats samples for incubation, and automates pipetting of beads, buffers, and enzymes. It can be used in research or IVD mode and monitored and managed remotely using the QIAsphere app.  

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FDA grants EUA for Thermo Fisher monkeypox test

February 2023—Thermo Fisher Scientific announced the FDA has granted emergency use authorization for its Applied Biosystems TaqPath Monkeypox/Orthopox Virus DNA kit, a polymerase chain reaction test designed to detect non-variola orthopoxviruses, including monkeypox virus, in approximately three-and-a-half hours. The test is intended for the qualitative detection of DNA from monkeypox virus (clades one and two) and screening for non-variola orthopoxviruses in human lesion swab specimens from patients suspected of monkeypox infection by their health care provider. The test is for in vitro diagnostic use.  

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SD Biosensor, SJL acquire Meridian Bioscience

February 2023—SD Biosensor and SJL Partners LLC, both based in South Korea, have completed the transaction to acquire Meridian Bioscience. Meridian will continue to operate as an independent entity, under new ownership, headquartered in Cincinnati. Meridian offers immunoassay and molecular raw materials for human and veterinarian diagnostics testing, and it plans to add service capabilities for lyophilized bead and lateral flow test manufacturing.

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FDA clears Simplexa Congenital CMV Direct assay

January 2023—DiaSorin announced it has received FDA 510(k) clearance for its Simplexa Congenital CMV Direct kit. The molecular diagnostic test enables direct detection of cytomegalovirus DNA in saliva swab and urine specimens from babies 21 days old or younger. It is the first kit to receive FDA clearance for CMV detection from both saliva swab and urine specimens.

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Hologic awarded contract from BARDA

December 2022—Hologic has been awarded a $19 million contract from the Biomedical Advanced Research and Development Authority. The funding will help bring Hologic’s Panther Fusion SARS-CoV-2/Flu A/B/RSV and Aptima SARS-CoV-2 assays in line with the FDA’s in vitro diagnostic standards and support clinical efforts to obtain claims for nasal samples using the Panther Fusion as well as market authorization for COVID-19 testing of asymptomatic individuals who have reason to be tested. The Aptima SARS-CoV-2 assay received EUA in May 2020, and the CE-marked Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is under development in the United States. The project has been funded with federal funds from the U.S. Department of Health and Human Services, the Administration for Strategic Preparedness and Response, and BARDA.

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Sebia acquires Zeus Scientific

December 2022—Sebia announced the acquisition of Zeus Scientific, an in vitro diagnostic company based in Branchburg, NJ. Sebia, headquartered in Lisses, France, says the acquisition will expand its capabilities and product portfolio in autoimmunity and reinforce its operations and footprint in the United States. Financial terms of the agreement are undisclosed.

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FDA authorizes Abbott monkeypox test

December 2022—The FDA issued emergency use authorization to Abbott Molecular for the Alinity m MPXV, a real-time polymerase chain reaction test intended to detect monkeypox DNA using lesion swab specimens from individuals suspected of monkeypox virus infection. The test is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of PCR and in vitro diagnostic procedures. Testing is limited to CLIA-certified laboratories that meet the requirements to perform moderate- or high-complexity tests.

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Bio-Rad, NuProbe to develop digital PCR assays

December 2022—Bio-Rad Laboratories and NuProbe USA have entered into an agreement in which NuProbe will exclusively license its allele enrichment technologies to Bio-Rad for the development of multiplexed digital PCR assays. “Bio-Rad provides the leading solution for digital PCR, and we are committed to providing oncology researchers with technologies that enable everything from biomarker discovery to clinical trials and patient monitoring of minimal residual disease,” Simon May, EVP and president of Life Sciences at Bio-Rad, said in a joint press release. “We look forward to working with NuProbe USA to develop the next generation of highly multiplexed digital PCR assays as part of our expanding oncology offering.”

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Roche gets EUA for high-throughput monkeypox test

December 2022—Roche announced that the FDA has granted emergency use authorization for the Cobas MPXV for use on Cobas 6800/8800 systems. The real-time PCR test is for the qualitative detection of DNA from monkeypox virus in lesion swabs collected from individuals suspected of having monkeypox infection by their health care provider. The assay uses β-globin as an endogenous control to assess specimen adequacy. It detects monkeypox nucleic acids and the endogenous control in the same well.

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Verichem reference materials for lactate assays

December 2022—Verichem Laboratories announced the availability of a six-level, protein-based kit designed for the calibration or calibration verification of lactate assays on automated clinical systems. The liquid-stable, ready-to-use product contains concentration levels of lactate ranging from 3.2 mg/dL to 160 mg/dL. The format is free of glycols, surfactants, azides, and other interfering substances. Shelf life is 18 months from the manufacturing date.

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OGT launches NGS myeloid panel, library prep workflow

December 2022—OGT launched its SureSeq Myeloid Plus panel designed to detect a range of aberrations, including single nucleotide variations, insertions/deletions, internal tandem duplications, and partial tandem duplications in 49 genes implicated in myeloid disorders such as acute myeloid leukemia, myeloproliferative neoplasms, and myelodysplastic syndrome.

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FDA clears COVID-19 PCR test on Cobas 6800/8800 systems

November 2022—Roche announced that the FDA has granted 510(k) clearance for the Cobas SARS-CoV-2 Qualitative PCR test for use on the automated Cobas 6800 and Cobas 8800 systems. It is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in nasal and nasopharyngeal swab specimens collected from symptomatic patients who are suspected of having COVID-19 by their health care provider. The single-well, dual-target assay includes specific detection of SARS-CoV-2 and pan-sarbecovirus detection for the sarbecovirus subgenus that includes SARS-CoV-2.

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Thermo Fisher Scientific buys Binding Site

November 2022—Thermo Fisher Scientific announced it has entered into a definitive agreement to acquire the Binding Site Group from a shareholder group led by European private equity firm Nordic Capital. The all-cash transaction is valued at approximately $2.6 billion at current exchange rates, Thermo Fisher reported in a press release.

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Verichem reference materials for ethanol testing

November 2022—Verichem Laboratories announced the availability of a ready-to-use set of multilevel clinical reference materials for the calibration and calibration verification of ethanol assays on a range of diagnostic testing systems. The protein-based liquid standards are free of surfactants, glycols, azides, and other interfering substances. Each kit contains 5 mL of material per vial at the six available concentration levels and has a shelf life of 18 months when stored at 2° to 8°C. The product also contains a known linear relation for acetaminophen, lactate, and salicylate.

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Traceable updates four products

November 2022—Traceable announced it has updated four of its products—a refrigerator/freezer digital thermometer with probe, a thermohygrometer with clock, a three-channel timer with alarm, and a four-channel timer with clock—to be more user friendly, economical, and higher performing. The updates are based on feedback that the company gathered from customer focus groups and industry conversations to learn how clinics, laboratories, academic institutions, logistics companies, and other organizations use its products.

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FDA clears NanoZoomer S360MD slide scanner system

November 2022—Hamamatsu Photonics announced that the FDA granted 510(k) clearance to market the NanoZoomer S360MD high-throughput, automated slide scanner system for primary diagnostic use. It is intended to aid pathologists in reviewing and interpreting digital images of surgical pathology slides prepared from formalin-fixed, paraffin-embedded tissue.

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Cofactor Genomics reports OncoPrism data

October 2022—Cofactor Genomics presented initial results from the PREDAPT (Predicting Immunotherapy Efficacy from Analysis of Pre-treatment Tumor Biopsies) multicenter clinical trial at the Advances in Genome Biology and Technology Precision Health Meeting in September. The company says its data show that Cofactor’s OncoPrism test using predictive immune modeling was nearly twice as accurate as PD-L1 assays in determining who will benefit from immunotherapies such as Keytruda (pembrolizumab).

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Roche launches digital PCR system

October 2022—Roche launched its Digital LightCycler system, the company’s first digital polymerase chain reaction system, for precise DNA and RNA analysis in areas such as oncology and infectious diseases. The instrument features three unique reaction plates, six channel multiplexing capabilities, and a 5× concentrated master mix reagent. Run time is two to four hours with up to 96 samples per run.

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Verichem reference materials for protein assays

October 2022—Verichem Laboratories offers liquid-stable, ready-to-use clinical reference materials for protein testing. The multilevel and combined Total Protein/Albumin Standard Kit, along with the optional and standalone level F, and the Microprotein Standard Kit are designed and manufactured for the calibration and calibration verification of albumin and total protein assays on a range of clinical testing systems, including from Abbott Diagnostics, Beckman Coulter, Roche Diagnostics, and Siemens Healthineers.

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Grenova releases study on reducing cost with pipette tip washer

October 2022—Grenova released a case study in which enzyme-linked immunosorbent assay validation was performed with pipette tips that were washed and reused five times using the company’s Tipnovus system. Grenova says its technology decreased overall cost per clinical diagnostic test, resulting in an increased profitability margin, and that the laboratory also decreased plastic waste.

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Bio-Rad extends range of StarBright dyes

October 2022—Bio-Rad extended its range of StarBright dyes with the StarBright Violet 760, StarBright UltraViolet 575, and StarBright UltraViolet 605 dyes, to provide greater flexibility in multicolor flow cytometry panels. The company says the dyes offer improved brightness with narrow excitation and emission profiles for precise resolution, are resistant to photobleaching, and do not lose signal in fixation. They are compatible with the Bio-Rad ZE5 cell analyzer and S3e cell sorter and most flow cytometers without the need for special buffers.

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FDA clears DiaSorin Simplexa COVID-19 test

October 2022—DiaSorin received 510(k) clearance from the FDA for its Simplexa COVID-19 Direct kit. The sample-to-answer test detects SARS-CoV-2 directly from nasopharyngeal or nasal swab specimens and is designed for use on the Liaison MDX system. The test targets two regions of the viral genome and results are available in a little over an hour.

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StatLab TissueGuard processing gel

October 2022—StatLab has released Tissue­Guard, an agarose gel that stabilizes and protects small or fragile specimens during processing while allowing reagent penetration. Tissue­Guard can be used for cytology samples, including fine-needle aspirates, urine and nongynecological specimens, and other specimens using cell block preparation, and for histology applications, including needle biopsies, nerves, small arteries, aggregates, lymph nodes, and small tissue fragments. The gel does not stain and remains invisible when blocks are cut.

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Audit Linearity LQ hs-CRP for Ortho Vitros

October 2022—Audit MicroControls has announced the availability of its Linearity LQ hs-CRP for Ortho Vitros. The product is intended to simulate human patient serum samples for determining linearity, calibration verification, and verification of the reportable range for hs-CRP. The product consists of five levels of human serum and has an open-vial stability of five days when stored at 2° to 8°C.

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Roche receives EUA for Cobas SARS-CoV-2 Duo

September 2022—Roche announced that the FDA issued emergency use authorization for the Cobas SARS-CoV-2 Duo for use on the fully automated Cobas 6800/8800 systems. The real-time RT-PCR assay is for the in vitro qualitative and quantitative detection of SARS-CoV-2 RNA in nasal and nasopharyngeal swab specimens. The assay also performs quantitation of SARS-CoV-2 RNA levels in the collected specimen; however, only the qualitative result of the assay is intended for use as an aid in diagnosing SARS-CoV-2 infection in patients suspected of COVID-19 by their health care provider.

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Bio-Rad launches RNA library prep kit

September 2022—Bio-Rad Laboratories has launched its SEQuoia Express Stranded RNA Library Prep Kit. The three-tube kit uses a novel reverse transcriptase with ligation-free adapter addition chemistry to yield a reproducible, quantitative RNA sequencing library in three hours. The kit enables users to construct robust libraries that capture mRNA and long noncoding RNA (>200 bp) transcripts for differential gene expression analysis and novel transcript discovery.

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BD, Accelerate announce collaboration for antimicrobial ID Dx

September 2022—BD and Accelerate Diagnostics announced a worldwide commercial collaboration agreement in which BD will offer Accelerate’s rapid testing solution for antibiotic resistance and susceptibility. Under the agreement, BD will market and sell the Accelerate Pheno system and Accelerate Arc module and associated test kits through its worldwide sales network in territories where products have regulatory approval or registration.

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BD COVID-19, flu A/B, RSV test gets CE mark

September 2022—BD announced that the BD Max Respiratory Viral Panel, a molecular diagnostic combination test for SARS-CoV-2, influenza A and B, and respiratory syncytial virus, has been CE marked to the IVD directive 98/79/EC. The test uses a single nasal swab or a single nasopharyngeal swab sample to determine if a patient has COVID-19, flu, or RSV.

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Roche COVID-19 test detects, differentiates BA.2.75

September 2022—Roche and its subsidiary TIB Molbiol have developed a COVID-19 test that detects and differentiates the BA.2.75 subvariant. The VirSNiP SARS-CoV-2 Spike 147E 152R test, for research use only, targets two of the known unique mutations, K147E and W152R, in BA.2.75, which allows clear differentiation against other notable subvariants. The test is for use on the Lightcycler and Cobas z480 instruments and is available worldwide.

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Bio-Rad launches two negative run controls

August 2022—Bio-Rad Laboratories launched two new Exact Diagnostics products. The Exact Diagnostics Synthetic Negative Run Control is screened negative for nine targets, Anaplasma phagocytophilum, Babesia microti, Bartonella quintana, Borrelia burgdorferi, Ehrlichia chaffeensis, enterovirus coxsackievirus A9, HSV-1 and HSV-2, and varicella zoster virus. The Exact Diagnostics HAI Negative Run Control is screened negative for Clostridium difficile, methicillin-resistant Staphylococcus aureus, and methicillin-susceptible Staphylococcus aureus.

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CorePath, Cizzle Biotech to develop early-stage lung cancer test

August 2022—CorePath Laboratories announced a partnership with U.K.-based diagnostics developer Cizzle Biotech to develop and offer a proprietary early-stage lung cancer test throughout the United States. Cizzle Biotech’s proof-of-concept prototype test is based on the ability to detect a stable plasma biomarker, a variant of CIZ1 known as CIZ1B. CIZ1 is a naturally occurring cell nuclear protein involved in DNA replication, Cizzle Biotech says, and the targeted CIZ1B variant is highly correlated with early-stage lung cancer.

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Reference materials for urine chemistry, bilirubin assays

August 2022—Verichem Laboratories now offers a range of liquid-stable and ready-to-use biosynthetic clinical reference materials for use with urine chemistry assays and designed for system calibration and calibration verification testing on a variety of clinical testing platforms, including from Abbott, Beckman Coulter, Roche, and Siemens Healthineers.

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Bruker launches NMR-based long COVID test

August 2022—Bruker Corp. has launched PhenoRisk PACS RuO, a research use only nuclear magnetic resonance test for molecular phenomics research on blood samples of patients with post-acute COVID syndrome (PACS), or long COVID. The test uses a multiplexed combination of biomarkers and is for research on early-stage risk factors on longitudinal recovery monitoring and on potential secondary organ damage in cardiovascular disease, type 2 diabetes, kidney dysfunction, and inflammation. It runs on the Avance IVDr NMR spectroscopy system, which produces results in 20 minutes.

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CSF false-bottom tube

August 2022—Sarstedt announced the availability of a false-bottom tube for cerebrospinal fluid with an elevated conical base. The tube was developed and validated for Roche, specifically for use with Roche’s new generation of Elecsys immunoassays designed to detect Alzheimer’s disease biomarkers on Cobas e analyzers. The tubes are manufactured from medical-grade polypropylene and have HDPE screw caps that are leak resistant at 95 kilopascals.

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CE-IVD-marked TaqPath respiratory viral panel

August 2022—Thermo Fisher Scientific has launched its Applied Biosystems TaqPath Respiratory Viral Select panel. The CE-IVD-marked molecular assay panel provides results in approximately three hours and tests for adenovirus, human metapneumovirus, rhinovirus/enterovirus, and parainfluenza virus using PCR technology. RNase P and positive controls are included to offer sample-to-result reliability. The solution is scalable, allowing laboratories to run from one to 94 samples simultaneously.

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CFX Duet Real-Time PCR system

August 2022—Bio-Rad Laboratories has launched the CFX Duet Real-Time PCR system to support researchers in developing singleplex and duplex quantitative PCR assays. The CFX Duet system offers the robust thermal performance and proprietary, accurate optical shuttle system of the company’s CFX Opus system. It is a two-color system that is factory calibrated for common dyes and allows the quantification of up to two targets in genotyping and multiple gene expression analyses without the need for passive reference dyes. An additional fluorescence resonance energy transfer mode supports protein melt analysis for basic protein characterization.

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EKF to distribute FDA-cleared Lucica glycated albumin test

July 2022—EKF Diagnostics announced the availability of the FDA-cleared Lucica Glycated Albumin-L test kit, manufactured by Asahi Kasei Pharma Corp. and sold exclusively in the United States by EKF. Lucica Glycated Albumin-L is a specific, quantitative test for glycated albumin for the intermediate-term monitoring of glycemic control in patients with diabetes.

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Steripath use studied hospitalwide

July 2022—Magnolia Medical Technologies, developers of the FDA 510(k)-cleared Steripath platform for reducing blood culture contamination for sepsis testing accuracy, announced the publication of results from a study performed by United Hospital Center, a member of the West Virginia University Health System.

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PerkinElmer launches BioQule NGS system

July 2022—PerkinElmer has launched its research use only BioQule NGS system, an automated benchtop solution for next-generation sequencing library preparation of up to eight samples. The system requires as little as 10 ng of starting material per run to create libraries. By incorporating automated thermocycling, integrated quality control through optical quantification, and robust liquid-handling technology in a single device, the company says the system enables researchers to produce high-quality NGS libraries that yield reliable, reproducible results.

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Illumina introduces pan-cancer CDx

July 2022—Illumina announced that a companion diagnostic indication has been added to its CE-marked in vitro diagnostic TruSight Oncology Comprehensive (EU) test. The CDx pan-cancer indication will allow identification of cancer patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase gene fusions including NTRK1, NTRK2, or NTRK3 and who may benefit from targeted therapy with Bayer’s Vitrakvi (larotrectinib), a genomically matched treatment.

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Creative Dx releases Nipah virus mAb pairs

July 2022—Creative Diagnostics has released a range of Nipah virus recombinant antigens and monoclonal antibody pairs. The monoclonal antibodies can be used as a pair in sandwich ELISA with the recombinant protein or in capture IgM assays. The products are specific to Nipah virus, with no cross-reaction with dengue, Zika, and chikungunya envelope proteins.

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Proscia, Hamamatsu digital pathology collaboration

May 2022—Proscia and Hamamatsu Photonics are collaborating to accelerate the adoption of digital pathology. The agreement aims to increase the availability of the companies’ best-of-breed solution, which combines Proscia’s Concentriq platform and Hamamatsu’s NanoZoomer series of whole slide scanners, to laboratories. Users of Hamamatsu’s scanners can integrate their images and all other data into an open ecosystem centered around Concentriq. Under the agreement, customers will receive support with implementation.

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CelLock cell-block prep kit

May 2022—Source Medical Products announced it is carrying CelLock, a kit that standardizes the preparation of formalin-fixed, paraffin-embedded cell blocks. Included in the kit is a proprietary product called CelLGel, which is used in concert with a proprietary filter to collect and process 99.7 percent of the initial patient specimen into the cell block. The filter is included in the cell block to provide a visual cue, the company says, to make the tasks of embedding and microtomy easier and more exacting. The cellular proteomic and genetic information within the specimen is preserved for immunohistochemical, molecular, and ancillary testing.

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Verichem reference materials for ammonia

June 2022—Verichem Laboratories announced the availability of a multilevel set of liquid-stable, ready-to-use clinical reference materials for the calibration and calibration verification of ammonia assays. The materials are universally compatible and can be used with a range of clinical testing systems, including from Abbott Diagnostics, Beckman Coulter, Roche Diagnostics, and Siemens Healthineers.

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NxTAG gastrointestinal panel gets CE mark

June 2022—DiaSorin announced that Luminex, a DiaSorin company, CE marked its xMAP NxTAG Gastrointestinal Pathogen Panel (GPP). The new panel is a multiplex test that detects nucleic acids from 16 clinically relevant bacterial, viral, and parasitic pathogens in stool samples on the Magpix system.

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Sysmex America to distribute Exbio antibodies

June 2020—Sysmex America has expanded its reagent portfolio by becoming a distributor of more than 450 Exbio single-color antibodies, cell stains, and buffering solutions. The company offers a comprehensive variety of analyte-specific reagent and research use only antibodies for immunophenotyping, cell staining and processing, and vitality assays, as well as for other research applications.

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Tribun Health enters pharmaceutical market

June 2022—Tribun Health announced its expansion into the pharmaceutical market with the appointment of Loic Dartois as vice president of pharma. Dartois joined Tribun Health in March and is developing commercial offerings for the pharma industry. “Digital pathology data combined with best-in-class AI models has the power to improve treatments’ responses to a better targeted population,” Dartois said in a press release. “Thanks to its growing footprint in health care institutions in Europe and North America, Tribun Health is best positioned to support the pharmaceutical industry in its precision medicine transformation using an industry-leading digital pathology platform and deploying a thought leadership AI team.”

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Bio-Rad introduces anti-cemiplimab antibodies

June 2022—Bio-Rad Laboratories introduced a range of antibodies specific to cemiplimab (Libtayo) that inhibit the binding of the drug to its target, human programmed death receptor-1. The ready-made antibodies are suitable for developing selective and sensitive assays for the bioanalysis and drug monitoring of cemiplimab.

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Siemens gets breakthrough device designation for sNfL assay

June 2022—Siemens Healthineers announced the FDA has granted breakthrough device designation for the Advia Centaur serum neurofilament light chain (sNfL) assay, developed in collaboration with Novartis Pharma. The assay quantitatively measures NfL in human serum and plasma and is intended to be used in conjunction with clinical, imaging, and laboratory findings as an aid in identifying adult patients with relapsing multiple sclerosis who are at lower risk, versus higher risk, of multiple sclerosis disease activity.

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ZeptoMetrix NATtrol SARS-CoV-2 omicron control

June 2022—ZeptoMetrix announced the release of its NATtrol SARS-CoV-2 Omicron External Run Control, for research use only, to evaluate the performance of nucleic acid tests for determining the presence of SARS-CoV-2 omicron variant RNA. The control is formulated with purified, intact organisms and is for use with a real-time PCR thermal cycler. The product is available in six 0.5-mL vials and is refrigerator stable at 2° to 8°C.

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Versant Dx announces strategy to accelerate use of digital pathology

June 2022—Versant Diagnostics has announced a strategy in which the company will focus on anatomic pathology, precision medicine, and the digital transformation of the industry. The company said it is positioning itself to become the nation’s largest independent physician services company through the acquisition of independent pathology practices, and it will provide capital for practices to convert to digital pathology while maintaining physician leadership.

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CE-marked Nova Max Pro creatinine/eGFR meter launched in EU

June 2022—Nova Biomedical launched the CE-marked Nova Max Pro creatinine/eGFR meter system in the EU market. Nova Max Pro is designed to improve kidney care through kidney function screening and early detection of kidney disease in point-of-care settings outside the hospital. The meter and creatinine biosensor measure blood creatinine and calculate estimated glomerular filtration rate from a 1.2-μL capillary fingerstick blood sample in 30 seconds. The measuring technology is based on the Nova StatSensor Creatinine technology.

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Paragon Genomics unveils CleanPlex Emerging Variant Add-on V2

April 2022—Paragon Genomics announced the release of its Emerging Variant Add-on V2. The panel is designed to be used with existing CleanPlex SARS-CoV-2 products, the company says, to maintain high coverage for variant calling and identification as the virus evolves. It includes added primers for enhanced coverage of critical variants, such as alpha, beta, delta, mu, and omicron, and has been confirmed in silico to cover the defining and characteristic mutations of the omicron sublineages, BA.1, BA.2, and BA.3.

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Thermo Fisher RT-LAMP tests for ID surveillance

April 2022—Thermo Fisher Scientific has launched two reverse transcription loop-mediated isothermal amplification (RT-LAMP)–based solutions for research use only. The Invitrogen Colorimetric ReadiLAMP Kit, SARS-CoV-2, is an off-the-shelf assay designed to provide accurate, robust detection of SARS-CoV-2 from saliva, nasal, or nasopharyngeal swab samples. The kit includes two protocols, one for crude sample types with a 30-minute turnaround time and one for increased sensitivity with purified RNA sample types that has a one-hour turnaround time.

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FDA clears Rheonix Encompass MDx for STIs

April 2022–Rheonix announced that the FDA has granted 510(k) clearance for its automated Encompass MDx Workstation along with its STI TriPlex assay and Male Urine Collection Kit for the detection of sexually transmitted infections. The molecular testing device is a closed system that is automated from sample loading to result reporting, provides direct tube sampling, and contains all the reagents needed.

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Qiagen expands QIAstat-Dx syndromic testing menu

April 2022—Qiagen announced test enhancements to its QIAstat-Dx, a fully integrated molecular diagnostic testing solution with one-step sample processing that provides results in about one hour. The company is awaiting U.S. regulatory approval of a gastrointestinal panel designed to detect 22 common viral, bacterial, and parasitic pathogens that can cause potentially life-threatening infections. Qiagen has also registered for CE marking a meningitis/encephalitis panel designed to analyze 15 pathogens simultaneously and help distinguish between meningitis and encephalitis.

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Verichem clinical reference materials for lithium

April 2022—Verichem Laboratories offers two multilevel, protein-based test kits of clinical reference materials for the calibration or calibration verification of lithium assays. Intended for use with direct and indirect ion-selective electrodes, colorimetric assays, and flame photometers, the Electrolyte Standard Kit and Serum ISE Standard Kit contain NIST-verified gravimetric concentrations for lithium. The liquid-stable, ready-to-use materials can also be used for quality control monitoring, method evaluations, post-maintenance testing, and routine troubleshooting.

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Opdivo + chemo approved as neoadjuvant treatment for NSCLC

April 2022—The FDA has approved Bristol Myers Squibb’s Opdivo (nivolumab) in combination with platinum-doublet chemotherapy for adult patients with resectable non-small cell lung cancer in the neoadjuvant setting. The treatment is approved regardless of PD-L1 status and is based on the CheckMate -816 trial, the first positive phase three trial of an immunotherapy-based combination used before surgery for resectable NSCLC.

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Alcor, Water Street partner to accelerate expansion

April 2022—Alcor Scientific is partnering with Chicago-based health care investor Water Street Healthcare Partners. Water Street will invest in Alcor’s research and development initiatives, product portfolio, and international expansion. Alcor has appointed Jim Post as chief executive officer to lead its next phase of innovation and growth.

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Roche launches Avenio Edge System

April 2022—Roche launched its Avenio Edge System, an all-in-one preanalytical platform that is designed to minimize manual touchpoints and includes ready-to-load reagents, validated protocols, onboard capabilities, and intuitive software to manage next-generation sequencing sample workflows.

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Qiagen expands QuantiFeron portfolio

March 2022—Qiagen announced expansion initiatives for its QuantiFeron portfolio, including developing new applications for technology designed to detect potentially deadly latent diseases. Among the company’s recent developments are the CE marking of its QuantiFeron SARS-CoV-2 assay, which launched in December 2021; the FDA’s expansion of the range of target groups that can be tested with the blood-based QuantiFeron-TB Gold assay, which now includes people with weakened immune systems, pregnant women, and children; and the Global Fund’s expert review panel for diagnostics’ approval of the QIAreach QuantiFeron-TB test, which means the test may now be procured by public health programs and institutions in more than 100 countries that qualify for Global Fund and Unitaid resources, as well as made available through the Stop TB Partnership’s Global Drug Facility.

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Asuragen launches CFTR testing kit

March 2022—Asuragen has launched a kit to detect pathogenic variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The AmplideX PCR/CE CFTR Kit, for research use only, is designed to detect about 93 percent of CFTR pathogenic variants observed in the U.S. population.

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Beckman, Illumina to develop applications for NGS system

March 2022—Beckman Coulter Life Sciences has signed an agreement with Illumina to develop applications on the Biomek NGeniuS Next Generation Library Preparation System, which is scheduled to launch during the second quarter of this year. The applications will be available to Biomek NGeniuS system users via a first-of-its-kind electronic application library, the company says.

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BD Kiestra IdentifA receives 510(k) clearance

February 2022—BD announced it has received 510(k) clearance from the FDA for the BD Kiestra IdentifA system, which is designed to automate the preparation of microbiology bacterial identification testing. The company says that by automating what are typically cumbersome manual steps, the BD Kiestra IdentifA may reduce the potential for human error when preparing samples for bacterial identification and produce more accurate diagnoses for patients.

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Bio-Rad SARS-CoV-2 variant neutralization antibody assays

February 2022—Bio-Rad Laboratories launched the Bio-Plex Pro Human SARS-CoV-2 Variant Neutralization Antibody Assays, for research use only. The assays allow scientists to measure neutralizing antibodies against wild-type and significant variants of the SARS-CoV-2 virus. The Bio-Plex Pro Human SARS-CoV-2 Variant Neutralization Antibody 11-Plex Panel is a ready-to-use 96-well kit containing premixed magnetic capture beads, a detection ACE2 receptor, a standard and positive control, and buffers that measure levels of neutralizing antibodies and percentage inhibition of the ACE2 receptor binding the viral antigens coupled on the beads.

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Clinical reference materials for cholesterol, electrolytes

February 2022—Verichem Laboratories offers an array of liquid-stable, ready-to-use multilevel reference materials for total cholesterol, high-density lipoprotein, and low-density lipoprotein testing. The Matrix Plus Total Cholesterol Reference Kit, the Matrix Plus Total Cholesterol Reference Level F, and the HDL Cholesterol Verifier Kit are intended for calibration verification and are compatible with a variety of wet chemistry clinical analyzers.

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Qiagen, Denovo to develop CDx for treatment of DLBCL

February 2022—Qiagen and Denovo Biopharma will collaborate to develop a blood-based companion diagnostic test to identify patients expressing Denovo Genomic Marker 1 (DGM1) who are likely to respond to Denovo’s investigational cancer drug DB102 for treatment of diffuse large B-cell lymphoma. DB102 (enzastaurin) is an investigational small molecule inhibitor of PKC-beta, which, if present, has been linked to DLBCL cases.

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EliTechGroup PCR kit differentiates SARS-CoV-2 omicron variant

February 2022—EliTechGroup MDx announced its research use only SARS-CoV-2 Extended test kit reliably differentiates the SARS-CoV-2 omicron (B.1.1.529) variant from other variants of concern. The in silico analysis was confirmed by testing patient samples positive for different SARS-CoV-2 variants including omicron. The SARS-CoV-2 Extended RUO reagents differentiate the alpha, beta, gamma, delta, and omicron variants in a single multiplex PCR and test for the presence of specific mutations in the regions of the S gene corresponding to positions 452, 484, and 501 of the spike protein. The combination of the melting curve analysis and the optical channel information allows for unambiguous differentiation of the five SARS-CoV-2 variants. The results can be interpreted and released when the reagents are used on the sample-to-result Elite InGenius system.

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Roche COVID-19 at-home test granted EUA

February 2022—Roche announced that the FDA has granted emergency use authorization for its COVID-19 At-Home Test. The test uses an anterior nasal swab sample that can be self-collected and self-tested by people ages 14 years and older and by an adult for children ages two to 13 years old. Results are available in as few as 20 minutes for SARS-CoV-2 and all known variants of concern, including omicron.

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Siemens SARS-CoV-2 testing portfolio detects omicron

January 2022—Siemens Healthineers announced that the company’s SARS-CoV-2 tests are designed to detect the omicron variant. The company evaluated the potential impact of the variant on the Clinitest Rapid COVID-19 antigen test; the FTD SARS-CoV-2 assay, a PCR test; and the Atellica IM/Advia Centaur SARS-CoV-2 antigen assay (CoV2Ag). To assess the potential impact of the Clinitest rapid test and the CoV2Ag assay, Siemens’ R&D team analyzed the sequence data of the omicron variant nucleocapsid protein, which demonstrated greater than 98 percent sequence homology of the nucleocapsid protein to other SARS-CoV-2 variants. The Clinitest Rapid COVID-19 Antigen Self-Test has a sensitivity of 97.25 percent and a specificity of 100 percent compared with a PCR, or nucleic acid-detection method, and provides results in 15 minutes.

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Bio-Rad adds SARS-CoV-2 S gene delta-kappa variants control

January 2022—Bio-Rad Laboratories launched its Exact Diagnostics SARS-CoV-2 S Gene Delta-Kappa Variants Control for research testing. The control includes lineages B.1.617.1, B.1.617.2 (AY sublineages), and B.1.617.3. The product is an addition to the company’s SARS-CoV-2 S gene variants controls alpha, beta, epsilon, and gamma, which were released in August.

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LumiraDx, Audere offer at-home self-collection kit

January 2022—LumiraDx announced a partnership with digital health nonprofit Audere to offer a COVID-19 nasal specimen collection kit that has been authorized for use with the LumiraDx SARS-CoV-2 RNA Star Complete assay to process self-collected samples. SARS-CoV-2 RNA Star Complete has received FDA emergency use authorization for use by authorized laboratories. Laboratories using SARS-CoV-2 RNA Star Complete will be able to integrate Audere’s HealthPulse@home into their systems.

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Co-Diagnostics to acquire Idaho Molecular, Advanced Conceptions

January 2022—Co-Diagnostics has entered into definitive agreements with Idaho Molecular and Advanced Conceptions in which both companies will become wholly owned subsidiaries of Co-Dx. Salt Lake City–based Co-Dx has been working with Idaho Molecular and Advanced Conceptions on the development of Co-Dx’s at-home, point-of-care diagnostic device. The transactions will provide Co-Dx with existing and future assets and intellectual property related to the platform.

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Roche launches Cobas 5800 molecular Dx system in CE markets

January 2022—Roche launched its Cobas 5800 system in countries accepting the CE mark. The real-time PCR molecular testing solution is built to offer a fully automated workflow that encompasses sample supply, transfer and preparation, amplification and detection, result calculation, and delivery to the laboratory information system. The single module enables a walkaway time of up to eight hours.

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Seegene PCR test IDs omicron, VOCs in one tube

January 2022—Seegene unveiled the Novaplex SARS-CoV-2 Variants VII assay for research use only. The assay identifies positive COVID-19 cases and distinguishes between alpha, beta, gamma, delta, and omicron and its stealth version. The RT-PCR test targets five analytes including the RdRP gene and three omicron S-gene mutations, E484A, N501Y, HV69/70 deletion. It also targets endogenous internal controls, which serve as a control to verify specimen validity.

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Postmortem oral fluid toxicology testing

January 2022—Death investigators are tasked with the responsibility of providing irrefutable and accurate determinations in the cause and manner of death in a timely fashion for ongoing investigations. Outcomes of any death may be revealed by the specimens submitted for toxicology analysis. The conundrum of ample opinions is that there is no “one size fits all” when selecting appropriate specimens. Human nature tends to rely on traditional approaches for the collection, processing, and reporting of results because it’s easier to stay status quo. However, with drug overdose deaths increasing, reports are further delayed, causing an influx of backlogged cases. To assist with these issues, our laboratory developed an economical, time-efficient, safe, and less-invasive collection method that delivers real-time results within 24 to 48 hours, accelerating the autopsy process and the ability to close cases expeditiously.

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Bio-Plex Pro IgA, IgM SARS-CoV-2 panels

December 2021—Bio-Rad Laboratories launched its Bio-Plex Pro Human IgA and IgM SARS-CoV-2 panels to detect IgA and IgM antibodies against four SARS-CoV-2 antigens. The two new panels along with the company’s existing Bio-Plex Pro Human IgG SARS-CoV-2 N/RBD/S1/S2 4-Plex panel aim to assist researchers in developing vaccines and to help public health researchers who perform seroprevalence studies based on serology specimens identify individuals who may have been exposed to SARS-CoV-2.

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FDA approves QuantiFeron-TB Gold Plus on Liaison XS

December 2021—Qiagen announced that the FDA has approved the Liaison QuantiFeron-TB Gold Plus assay for use on DiaSorin’s automated Liaison XS platform. The Liaison QuantiFeron-TB Gold Plus tests for interferon gamma released from T cells that have encountered TB. The assay was developed by Qiagen and DiaSorin to offer streamlined laboratory automation for latent TB screening.

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Sysmex TH-11 urinalysis decapper unit

December 2021—Sysmex introduced its TH-11 Urine Sample Decapper Unit, which is designed to be used in conjunction with the Sysmex UN-Series Automated Urinalysis Solution. The unit is intended to eliminate manual decapping work, which can reduce workplace repetitive injuries, streamline work processes, and reduce exposure to biological hazards. The TH-11 comes in desktop or wagon modules.

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PixCell Medical opens U.S. subsidiary in Denver

December 2021—PixCell Medical (Yokne’am Illit, Israel) announced it has opened a U.S. subsidiary in the Denver metropolitan area. The new office aims to increase logistical and commercial support for the company’s U.S. clients and will handle order fulfilment across the country as well as provide additional clinical and technical support to customers.

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Olympus announces first results of AI-based Dx tool for gastric cancer

December 2021—The results of Olympus’ ongoing joint research program to create an AI-based pathology diagnostic tool were announced at the Japan Society of Digital Pathology Study annual meeting. The AI tool was able to achieve 100 percent sensitivity and 50 percent or higher specificity for all gastric biopsy pathology specimens analyzed from the six facilities participating in the study.

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LumiraDx COVID-19 antigen test gets expanded EUA

December 2021—LumiraDx announced that the FDA’s emergency use authorization for its SARS-CoV-2 antigen test has been expanded to include screening of asymptomatic individuals. This claim builds on its existing claim that covers use of the test in individuals suspected of having COVID-19 by their health care provider within 12 days of symptom onset. The test received EUA in August 2020.

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Bio-Rad RP positive run control for SARS-CoV-2

December 2021—Bio-Rad announced its Exact Diagnostics RP Positive Run Control for syndromic respiratory panels is now available with inactivated whole virus for SARS-CoV-2. The unassayed external quality control contains 23 respiratory analytes in one vial and is intended to monitor the performance of clinical respiratory assays. The control is a combination of whole, intact virus and bacteria that have been heated or chemically inactivated and synthetic RNA transcripts.

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Verichem reference materials for microprotein testing

November 2021—Verichem Laboratories offers ready-to-use, liquid-stable clinical reference materials for microprotein testing, suitable for use with turbidimetric and colorimetric test methods. The products are intended for the calibration and calibration verification of clinical systems testing for total protein and albumin in urine and cerebral spinal fluid. The kit contains a five-level set with 15 mL of material at each level and provides 10 individual certified concentrations in an azide-free format, incorporating human protein components for optimum reactivity.

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TaqMan panel updated to include mu strain

November 2021—Thermo Fisher Scientific has updated its research use only Applied Biosystems TaqMan SARS-CoV-2 Mutation Panel to include the mu strain. Laboratories can build their own panel from a menu of more than 50 verified real-time PCR assays that allows the user to identify relevant SARS-CoV-2 mutations and adapt as additional mutations and variants emerge.

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Roche launches three respiratory panels in CE markets

November 2021—Roche launched in the CE market three molecular PCR diagnostic test panels to simultaneously detect and differentiate flu A, flu B, and respiratory syncytial virus; adenovirus, human metapneumovirus, and enterovirus/rhinovirus; and parainfluenza 1, 2, 3, and 4. The tests can be run together or individually from a single nasopharyngeal swab specimen and run on the Cobas Omni Utility Channel for use with the Cobas 6800/8800 systems.

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Microbiologics SARS-CoV-2 virus antigen controls

November 2021—Microbiologics has launched its SARS-CoV-2 Whole Virus Antigen Control, which can be used in the point-of-care setting for the detection of SARS-CoV-2 antigens and for monitoring the extraction, amplification, and detection in nucleic acid testing. In antigen-based applications, the high titer formula provides a clear positive reaction to monitor the detection of SARS-CoV-2 viral antigens. Each kit contains six individually packaged lyophilized swabs.

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Simplexa COVID-19, flu A/B assay gets CE mark

November 2021—DiaSorin Molecular announced that it has CE marked its Simplexa COVID-19 and Flu A/B Direct kit. The multiplex test allows for the in vitro qualitative detection and differentiation of nucleic acid from SARS-CoV-2, influenza A, and influenza B from a patient sample in one reaction well. The assay is designed for use on the Liaison MDX and is run directly from nasopharyngeal swabs without the need for off-board extraction.

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PerkinElmer gets EUA for SARS-CoV-2 respiratory panel, ELISA

November 2021—PerkinElmer announced that the FDA has issued emergency use authorization for its PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 assay. The RT-PCR test provides simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus isolated from nasopharyngeal swabs, anterior nasal swabs, and midturbinate swabs.

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Hardy Diagnostics releases group A strep agar

November 2021—Hardy Diagnostics released its HardyChrom Group A Strep agar, a chromogenic medium recommended for the selective cultivation and differentiation of group A streptococcus from clinical specimens. Identification can be made based on colony color—the medium will display red-brown or red-orange colonies on the Hardy­Chrom Group A Strep agar when Streptococcus pyogenes is present; non-group A streptococcus isolates will appear as blue, clear, or white colonies.

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Thermo Fisher appointed U.S. distributor of APAS Independence

November 2021—Clever Culture Systems signed a five-year agreement for Remel, a part of Thermo Fisher, to be the exclusive U.S. distributor of the APAS Independence. The FDA-cleared automated culture plate reader will be added to Thermo Fisher’s portfolio of microbiology products in the United States. Under the agreement, Thermo Fisher will provide sales and marketing, installation, maintenance, and support services to customers in the United States.

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BD FACSymphony A1 Cell Analyzer

October 2021—BD launched the BD FACSymphony A1 Cell Analyzer, a fluorescence-activated cell analyzer that offers advanced research capabilities in a benchtop design. Fluorescence-activated cell sorter (FACS) technology enables precise isolation of selected single cells from complex samples.

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Siemens launches Sysmex CN-3000, CN-6000 hemostasis systems

October 2021—Siemens Healthineers has launched Sysmex’s CN-3000 and CN-6000 hemostasis systems for mid- and high-volume coagulation testing. A broad menu of Siemens’ routine and specialty coagulation assays that help identify blood coagulation disorders such as abnormal blood clotting or bleeding, including Siemens’ Innovance Anti-Xa assay for heparin and direct oral anticoagulant testing, can be performed on the CN-3000 and CN-6000 instruments.

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Mesa Labs to acquire Agena

October 2021—Mesa Laboratories has entered into a definitive agreement to acquire Agena Bioscience for a cash price of $300 million, subject to customary purchase price adjustments. The transaction is expected to be completed by Dec. 31 and is subject to customary conditions, including receipt of applicable regulatory approvals.

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Thermo Fisher expands hematology-oncology NGS portfolio

October 2021—Thermo Fisher Scientific announced a suite of Ion Torrent Oncomine immune repertoire assays designed to detect potentially malignant clones of T cells and B cells. Using proprietary Ion AmpliSeq technology, the pan-clonality assays target multiple parts of the B- and T-cell immune receptors using a single reaction with ultra-high sensitivity.

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Cepheid gets EUA for Xpert Xpress CoV-2/Flu/RSV Plus

October 2021—Cepheid received FDA emergency use authorization for its Xpert Xpress CoV-2/Flu/RSV Plus, a rapid molecular diagnostic test for qualitative detection of the viruses causing COVID-19, flu A, flu B, and respiratory syncytial virus infections from a single patient sample. The Plus version of the test provides three gene targets for SARS-CoV-2 detection—N2, E, and RdRP. The test is designed for use on any GeneXpert system and results are delivered in about 36 minutes.

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Steripath Micro available for use in children’s hospitals

October 2021—Magnolia Medical Technologies announced the commercial availability of its Steripath Micro Initial Specimen Diversion Device designed for use in children’s hospitals. Steripath Micro is an FDA 510(k)-cleared device with the specific indication to reduce blood culture contamination. The small, lightweight device requires less than 1 mL of blood for patients with limited volumes or difficult intravenous access. The company says Steripath Micro has shown a zero percent contamination rate in two leading children’s hospitals during a three- month period.

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Roche POC SARS-CoV-2 test gets EUA

September 2021—Roche announced that the FDA granted emergency use authorization for the Cobas SARS-CoV-2 Nucleic acid test for use on the Cobas Liat System. The singleplex, RT-PCR test screens within 20 minutes both asymptomatic and symptomatic persons. The test, for point-of-care use, offers broad strain coverage of SARS-CoV-2 variants.

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Verichem carbon dioxide reference materials

September 2021—Verichem Laboratories offers a selection of ready-to-use carbon dioxide reference materials. The five-level standard kit along with an optional level F are intended for calibration and/or calibration verification of clinical systems and are suited for use with ion-selective electrode and wet testing methodologies.

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Qiagen NeuMoDx HAdV quant assay gets CE-IVD

September 2021—Qiagen’s NeuMoDx HAdV Quant Assay for the identification and quantification of human adenovirus DNA has received CE-IVD certification for the European Union and other countries that accept this mark. The tests can be run in true random access along with laboratory-developed tests.

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FDA approves pembrolizumab plus lenvatinib

September 2021—The Food and Drug Administration approved pembrolizumab (Keytruda, Merck) in combination with lenvatinib (Lenvima, Eisai) for patients with advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

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Sarstedt lithium heparin gel tubes

September 2021—Sarstedt introduced S-Monovette Lithium-Heparin Gel blood collection tubes, which feature a polymer-based gel layer with improved rheological properties to reduce centrifugation time. Tubes can be centrifuged in as few as four minutes to yield properly separated and stable plasma ready for immediate testing, the company says. The tubes are offered in three volume and size options: 2.7 mL (13 × 75 mm), 4 mL (13 × 75 mm), and 4.9 mL (13 × 90 mm).

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FDA approves avapritinib for advanced systemic mastocytosis

September 2021—Blueprint Medicines announced that the FDA approved Ayvakit (avapritinib) for the treatment of adult patients with advanced systemic mastocytosis, including aggressive systemic mastocytosis, systemic mastocytosis with an associated hematological neoplasm, and mast cell leukemia. Advanced systemic mastocytosis patients can now receive a targeted therapy designed to potently and selectively inhibit D816V mutant KIT.

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Cobas SARS-CoV-2 Test authorized for asymptomatic people

August 2021—Roche’s Cobas SARS-CoV-2 has received FDA emergency use authorization for testing individuals without symptoms or reasons to suspect COVID-19. This authorization supports the guidance update from the CDC to expand SARS-CoV-2 testing to include people without symptoms and applies to pooled samples containing up to and including six individual samples. Asymptomatic testing with the Cobas SARS-CoV-2 test is also available in countries accepting the CE mark.

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FDA clears GSD’s B. burgdorferi VlsE-OspC IgG/IgM assay

August 2021—Gold Standard Diagnostics announced the availability of its FDA-cleared B. burgdorferi VlsE-OspC IgG/IgM recombinant ELISA screen. The OspC antigen is highly specific for the detection of IgM antibodies and produces a superior first-tier screen, the company says, when used in combination with the recombinant VlsE. True Lyme-negative samples are eliminated prior to second-tier testing.

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Qiagen launches CE-marked Artus Prep&Amp

August 2021—Qiagen launched its Artus SARS-CoV-2 Prep&Amp UM Kit, which integrates a liquid-based sample preparation technology for COVID-19 testing that takes two minutes or less with the provided real-time PCR assay. The kit uses common transport media as the starting material and provides all reagents required for sample to result on suspected SARS-CoV-2 patient samples. The workflow can support up to 672 samples per cycler in an eight-hour shift.

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Reference materials for bilirubin, cholesterol, uric acid

August 2021—Verichem Laboratories offers liquid-stable, protein-based clinical reference materials for total and direct bilirubin assays. The Bilirubin Standard Kit, Tru-Zero Bilirubin Standard, and extended-range Level F Bilirubin Standard are intended for CLIA calibration verification with wet chemistry testing systems. Verichem’s BR2 Bilirubin Calibrator is available for use exclusively with the BR2 Bilirubin Stat Analyzer from Advanced Instruments.

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LGC SeraCare blood TMB reference standards

August 2021—LGC SeraCare released two new blood tumor mutational burden reference standards, Seraseq Blood TMB Score 7 and Seraseq Blood TMB Score 26. The products complement the company’s Seraseq I-O portfolio of tissue-derived Seraseq gDNA TMB Score 7 and Score 26 and Seraseq FFPE TMB Score 7 and Score 26 products.

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Sarstedt BL 1200 Sort Connect

August 2021—Sarstedt introduced its BL 1200 Sort Connect, a preanalytical accessioning and sorting instrument that can be connected to integrated systems or analyzer lines. The unit features a bulk loader that requires no sorting or handling. Multiple tube sizes are accepted and barcodes are identified via the ID module.

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Bio-Rad launches InteliQ Diabetes Control

July 2021—Bio-Rad Laboratories launched its InteliQ Diabetes Control, the 10th product offered in the InteliQ format. The InteliQ Diabetes Control includes three distinct levels that aim to address HbA1c precision monitoring needs of a wide range of test methods. InteliQ quality controls are designed to empower labs to automate their QC workflow with load-and-go efficiency, and users have access to the Unity data management program.

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Diazyme launches beta-hydroxybutyrate assay

July 2021—Diazyme launched its FDA 510(k)–exempt Beta-Hydroxybutyrate Assay for the quantitative determination of beta-hydroxybutyrate. BHB serves as a guide for monitoring the progress of insulin therapy for diabetic ketoacid­osis and for patients presenting to the emergency room with documented hypoglycemia, acidosis, alcohol ingestion, or an unexplained increase in the anion gap.

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Bio-Rad SARS-CoV-2 variant RT-PCR assays

July 2021—Bio-Rad Laboratories launched SARS-CoV-2 variant RT-PCR assays for research use only. The assays can detect SARS-CoV-2 variants of concern, including P.1, B.1.351, and B.1.1.7, by distinguishing specific mutations in SARS-CoV-2 using reverse transcription PCR, often prior to a next-generation–sequencing workflow for confirmation.

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Roche adds high-throughput configurations to Cobas Pro

July 2021—Roche launched eight configurations for its Cobas Pro integrated solutions, in countries accepting the CE mark. As a result, the analyzer can deliver up to 4,400 tests per hour, doubling its previous testing capacity. It is now possible to add two analytical units of Cobas c 503 and/or Cobas e 801, consolidating up to four analytical units on one platform.

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SML Genetree Ezplex SARS-CoV-2 G Kit gets EUA

July 2021—The SML Genetree Sciences’ Ezplex SARS-CoV-2 G Kit has been granted FDA emergency use authorization. This is a real-time PCR in vitro diagnostic test for the qualitative detection of nucleic acid for SARS-CoV-2 RdRp and N genes from nasopharyngeal and oropharyngeal swabs and sputum specimens. The test can also be used for up to five pooled individual nasopharyngeal or oropharyngeal swabs. Testing of the FDA SARS-COV-2 Reference Panel showed a detection limit of 1,200 NAAT detectable units (NDU)/mL.

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Beckman launches quantitative COVID-19 IgG test

July 2021—Beckman Coulter launched its Access SARS-CoV-2 IgG (1st IS), a fully quantitative lab-based immunoglobulin G serology test that measures the quantity of antibodies against the virus that causes COVID-19. The assay is traceable to the First WHO International Standard for anti-SARS-CoV-2, 20/136, and reports results aligned with BAU/mL established by the World Health Organization.

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Thermo Fisher launches TaqPath COVID-19 2.0 test

July 2021—Thermo Fisher Scientific launched its CE-IVD-marked TaqPath COVID-19 Fast PCR Combo Kit 2.0. The kit uses an advanced assay design that compensates for current and emerging variants, the company says, by using eight targets across three genomic regions of the virus to help ensure the test provides accurate results even as the virus mutates.

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DiaSorin releases Simplexa SARS-CoV-2 Variants Direct assay

July 2021—DiaSorin Molecular has released the Simplexa SARS-CoV-2 Variants Direct assay, for research use only, to enable detection and discrimination of four SARS-CoV-2 mutations associated with circulating virus variants without requiring upfront RNA extraction. The assay allows for the in vitro qualitative differential detection of the mutations N501Y, E484K, E484Q, and L452R from nasopharyngeal and nasal swab specimens from individuals previously diagnosed with COVID-19. These mutations are present in potential variants of clinical interest including those that were isolated in the U.K. (B.1.1.7), South Africa (B.1.351), Brazil and Japan (P.1 and P.2), New York (B.1.526/B.1.526.1), California (B.1.427/B.1.429), Nigeria (B.1.525), and India (B.1.617/B.1.617.1/ B.1.617.2/B.1.617.3).

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Sysmex adds XN-10 blood bank mode to portfolio

July 2021—Sysmex America has added the FDA-cleared XN-10 Automated Hematology Analyzer with Blood Bank mode to its portfolio of hematology solutions. The analyzer supports red blood cell and platelet component testing and provides an automated complete blood count with differential for whole blood samples. The XN blood bank mode is intended for use in blood processing centers for QC release testing of post-processed components.

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FDA authorizes BD COVID-19, flu rapid antigen test

BD announced that the FDA granted emergency use authorization for its rapid antigen test that can detect SARS-CoV-2, influenza A, and influenza B in a single test. The BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B assay takes about 15 minutes to run on the BD Veritor Plus system and distinguishes between SARS-CoV-2, influenza A, and influenza B by providing definitive positive or negative individual digital display readouts for all three. BD plans to launch the test this summer for the 2021–2022 flu season. The test is intended for individuals who are suspected by a health care provider of having COVID-19, flu A, or flu B within six days of symptom onset.  

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OptraScan unveils OS-Ultra 320

June 2021—OptraScan launched the OS-Ultra 320 high-speed digital pathology scanner. The OS-Ultra 320 scans a 15- × 15-mm region at 40 × magnification in less than 60 seconds and features no-touch, continuous loading operation. The scanner uses real-time autofocus and offers a resolution of 0.25 μm/pixel. It accepts 25- × 75-mm and 50- × 75-mm slides with slide tolerances of ± 1 mm long, ± 1 mm wide, and ± 0.2 mm thick.

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PerkinElmer launches solutions to detect SARS-CoV-2 variants

June 2021—PerkinElmer launched two research use only solutions, PKamp Variant­Detect SARS-CoV-2 RT-PCR Assay and the next-generation-sequencing­–based Nextflex Variant-Seq SARS-CoV-2 Kit. The PKamp VariantDetect SARS-CoV-2 RT-PCR assay can detect mutations associated with B.1.1.7, B.1.351, and P.1 variants. The Nextflex Variant-Seq SARS-CoV-2 WGS workflow can detect all SARS-CoV-2 genetic changes relative to the strain originally identified in Wuhan, China.

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CellBlockistry 101

June 2021—CellBlockistry 101—The Textbook of Cell-Blocking Science addresses the cell-block-making process and cell-blocking-related challenges with advances in improved interdisciplinary coordination for optimal outcome and ongoing research in the field. The book is intended for pathologists, cytopathologists, cytotechnologists, cytoprep technologists, and others in fields associated with cell blocks directly or indirectly, including histotechnologists and radiologists.

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Roche to acquire GenMark Diagnostics

June 2021—Roche and GenMark Diagnostics have entered into a definitive merger agreement for Roche to acquire GenMark for about $1.8 billion on a fully diluted basis. GenMark’s syndromic panel testing portfolio will complement Roche’s molecular diagnostics portfolio, and Roche’s global network will enable expanded reach for GenMark’s products.

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FDA authorizes Beckman’s IgG antibody for SARS-CoV-2

June 2021—Beckman Coulter’s Access SARS-CoV-2 IgG II antibody assay received emergency use authorization from the FDA. The semiquantitative assay measures a patient’s level of antibodies in response to a previous SARS-CoV-2 infection and provides a qualitative and numerical result of antibodies in arbitrary units. It measures IgG antibodies directed to the receptor-binding domain of the spike protein of the coronavirus.

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Study highlights benefits of T2MR technology

June 2021—T2 Biosystems announced that Expert Review of Medical Devices published meta-analysis findings confirming that using the company’s magnetic resonance (T2MR) technology for identification of bloodstream infections provides faster time to detection, faster transition to targeted microbial therapy, faster de-escalation of empirical therapy, and shorter intensive care unit and hospital stay, and with comparable mortality rate versus the current blood culture standard (Giannella M, et al. Online ahead of print April 16, 2021. doi:10.1080/17434440.2021.1919508). Study authors systematically searched Medline, Embase, and Cochrane Central Register of Controlled Trials for randomized trials or observational controlled studies of patients with suspected bloodstream infections receiving a diagnosis with T2MR or blood culture, ultimately including 14 studies.

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Dyad COVID-19 specimen collection kits, components

May 2021—Dyad Enterprise, formed in early 2020 in response to the COVID-19 pandemic, offers customizable COVID-19 kits and components based on specimen type, handling, and shipping requirements. Products include customizable nasopharyngeal and oropharyngeal COVID-19 specimen collection kits as well as saliva collection kits. COVID-19 antigen tests are also available. All products are available for immediate shipment.

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Roche launches SARS-CoV-2 variant test

May 2021—Roche launched the Cobas SARS-CoV-2 Variant Set 1 Test to detect and differentiate mutations found in variants that originated in the U.K. (B.1.1.7), South Africa (B.1.351), and Brazil (P.1). This research use only laboratory test can be used to help scientists track mutation prevalence and to assess potential impact on diagnostics, vaccines, and therapeutics.

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Adaptive launches T-Detect COVID test

May 2021—Adaptive Biotechnologies Corp. launched its T-Detect COVID, a clinical T-cell–based test to identify people who have evidence of a cellular immune response against SARS-CoV-2. It uses Adaptive’s immunoSEQ technology to sequence T-cell receptors from a blood sample and identifies TCRs that the company has mapped for recognition of SARS-CoV-2 antigens.

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Promega launches XpressAmp Direct Amplification Reagents

May 2021—Promega Corp. released its XpressAmp Direct Amplification Reagents. The product contains components for performing extraction-free preparation of viral samples for PCR-based amplification using commonly available PCR reagents from samples collected by nasopharyngeal swab in universal or viral transport medium. The reagents allow the user to perform direct amplification analysis in RT-qPCR following a 10-minute, room-temperature incubation.

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FDA authorizes two Quidel SARS-CoV-2 tests

May 2021—Quidel received FDA emergency use authorization allowing the company to market its QuickVue At-Home OTC COVID-19 Test for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days, with at least 24 hours, but no more than 36 hours, between tests. This test is authorized for nonprescription home use with self-collected direct anterior nares specimens from individuals aged 14 years and older or with adult-collected anterior NS samples from individuals who are two years old or older.

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Diazyme SARS-CoV-2 IgG semiquantitative test gets EUA

April 2021—Diazyme received FDA emergency use authorization for its Semi-Quantitative DZ-Lite SARS-CoV-2 IgG CLIA test, which runs on the DZ-Lite 3000 Plus chemiluminescence analyzer. The FDA granted Diazyme an EUA for its qualitative DZ-Lite SARS-CoV-2 IgG CLIA test in July and has now authorized the Diazyme IgG assay to be used as a semiquantitative test.

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nRichDX unveils Revolution Semi-Automated Workflow

April 2021—nRichDX launched its Revolution Semi-Automated Workflow powered by Eppendorf’s epMotion 5073 instrument for the extraction of cfDNA and ctDNA from plasma and urine for liquid-based assay development. The semiautomated workflow automates the Revolution protocol’s wash and elution steps and is designed to increase yield, sensitivity, and throughput.

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Bio SB launches antibodies for SARS-CoV-2

April 2021—Bio SB has developed a new panel of SARS-CoV-2 antibodies to identify the COVID-19 virus, its receptors, and its cytokines by immunohistochemistry and immunofluorescence on formalin-fixed, paraffin-embedded biopsies. The antibodies identify ACE2, CD147, and TMPRSS2 receptors and include markers for immune response factors and vascular cells, with the intention to assess the pathological damage caused by COVID-19, cytokine storm syndrome, and coagulopathy, using single and multiplex IHC and immunofluorescence on FFPE tissues.

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Sarstedt specimen transport system

April 2021—Sarstedt introduced its dedicated transportation system for sending specimen tubes to the laboratory, the Tempus600. Sample tubes are placed directly into a sending station and arrive within seconds at a laboratory receiving station for processing. An optional connection module enables tubes to be loaded directly into laboratory automation systems, such as the Sarstedt BL 1200 bulk loader and sorter. The Tempus600 system and pipelines require little space, and installation takes two weeks.

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FDA authorizes Cue Health’s OTC COVID-19 test

April 2021—Cue Health has received FDA emergency use authorization for over-the-counter sale of its COVID-19 test. The Cue COVID-19 Test for Home and Over the Counter Use uses a lower nasal swab and provides results in about 20 minutes. The Cue OTC test is authorized for use by symptomatic and asymptomatic individuals, ages two and older.

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Quidel gets EUA for Solana SARS molecular test

March 2021—Quidel received emergency use authorization from the FDA to market its Solana SARS-CoV-2 assay, an isothermal reverse transcriptase­–helicase dependent amplification (RT-HDA) assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal and nasal swab specimens in viral transport media from patients suspected of having COVID-19 by their health care provider.

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Thermo Fisher saliva PCR test for COVID-19

March 2021—Thermo Fisher Scientific announced the availability of a direct from saliva PCR test for COVID-19 to enable widespread, high-frequency surveillance testing. The Applied Biosystems TaqCheck SARS-CoV-2 Fast PCR Assay Kit is a multiplexed RT-PCR assay for the qualitative detection and characterization of SARS-CoV-2 RNA (S and N genes) plus a human RNAse P assay to help assess sample adequacy. The assays are designed to work with raw saliva from research samples.

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Sarstedt Microvette automated processing tube

March 2021—Sarstedt introduced the Microvette APT for capillary blood collection. The tubes are available with either a 250-µL or 500-µL maximum fill volume. Both options have 75 × 13 mm external tube dimensions with a false bottom, feature a thin collection rim, are prepared with K2 EDTA, and have a pierceable and leak-resistant cap. The Microvette APT 250 offers a preassembled end-to-end capillary for collection. The Microvette APT 500 has a variable filling volume from 250 to 500 µL.

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LGC acquires Technopath

March 2021—LGC announced its acquisition of Technopath Clinical Diagnostics, expanding LGC’s position in the clinical diagnostics QC market. Technopath’s chemistry and immunoassay controls will be brought into LGC’s clinical diagnostics business unit.

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Adipress benchtop tissue dissection device

March 2021—Parker Isaac Instruments released the Adipress benchtop instrument designed to standardize tissue dissection for cancer staging. Through an automated compressive filtration cycle, the Adipress separates diagnostically irrelevant adipose tissue from underlying lymph nodes, lymphatics, and vasculature. The result is a compressed tissue mass that is 70 to 90 percent reduced in size, allowing for complete submission and microscopic review.

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PerkinElmer COVID-19 POC antigen test

March 2021—PerkinElmer launched its PerkinElmer COVID-19 Antigen Test for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in nasal or nasopharyngeal swab specimens. The lateral flow immunoassay test can be used to screen or to aid in diagnoses of COVID-19 in asymptomatic or symptomatic individuals. A positive or negative result can be obtained in 15 minutes.

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Euroimmun launches COVID-19 PCR, ELISA tests

February 2021—Euroimmun launched its CE-marked EuroRealTime SARS-CoV-2/Influenza A/B, which detects and differentiates genetic material from SARS-CoV-2 and influenza virus types A and B using throat swab samples of patients with acute symptoms, which can be indicative of COVID-19 or flu. The assay is compatible with common real-time PCR thermal cyclers and is available in countries that accept the CE mark. The EuroRealTime analysis software allows for standardized evaluation of test results. The company also launched its CE-marked SARS-CoV-2 Antigen ELISA, a laboratory diagnostic test for the direct detection of SARS-CoV-2 by semiquantitative determination of the virus-specific nucleocapsid protein in swab samples from the upper respiratory tract. Validation data revealed 93.6 percent sensitivity and 100 percent specificity as compared with real-time PCR tests. The assay can be automatically processed on all open ELISA platforms and is available in countries that recognize the CE mark.

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DiaSorin gets additional BARDA funding

February 2021—DiaSorin Molecular received additional federal funding from the Biomedical Advanced Research and Development Authority for the validation and submission of the Simplexa COVID-19 Direct kit and the Simplexa COVID-19 & Flu A/B Direct kit for FDA 510(k) clearance. The company initially received BARDA funding in March 2020 to test, validate, and submit the Simplexa COVID-19 Direct kit for FDA emergency use authorization.

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Randox SARS-CoV-2 antibody control

February 2021—Randox introduced its Acusera SARS-CoV-2 Antibody Control with reactive and nonreactive controls for anti SARS-CoV-2 to support assay validation and routine performance monitoring of serological assays for COVID-19. The third-party control is supplied in a liquid, ready-to-use format with a 30-day open vial stability at 2° to 8°C.

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Bio-Rad unveils online resource for immunoblotting

February 2021—Bio-Rad Laboratories launched an online library called Bio-Rad Western Blotting Learning Center. The center was created to provide researchers an online platform to learn about western blotting and offers information on the science of western blotting, best practices, tips and techniques, as well as guidance on how to troubleshoot experiments. It is available via the company’s website at bio-rad.com/LearnWestern.

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Bilirubin calibrator, standard kits

February 2021—Verichem Laboratories released a liquid-stable, protein-based BR2 Bilirubin Calibrator designed for the calibration of Advanced Instruments’ Advanced BR2 Bilirubin Stat Analyzer. The product has an open-vial stability claim of five days and an unopened shelf-life claim of 14 months at 2° to 8°C. The bilirubin calibrator is packaged in amber serum vials with rubber-lined closures and contains 5.0 mL of standard material, with two vials per kit.

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Sanger Institute’s COSMIC database licensed via Qiagen

February 2021—Qiagen announced that it now retains the exclusive rights to license and distribute the COSMIC database from the Wellcome Sanger Institute for commercial use, effective Jan. 1. COSMIC, the Catalogue of Somatic Mutations in Cancer, is a large, comprehensive resource for exploring the impact of somatic mutations in human cancer. The database is updated continuously and contains more than 37 million coding mutations. More than 20,000 researchers, bioinformaticians, and clinicians worldwide use COSMIC, which is available for download, annotation, and integration.

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FDA authorizes OTC at-home test for COVID-19

January 2021—The FDA issued an emergency use authorization for the first over-the-counter, at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test that detects fragments of proteins of the SARS-CoV-2 virus using a mid-turbinate nasal swab sample from any person two years of age or older. The Ellume home test correctly identified 96 percent of positive samples and 100 percent of negative samples in people who had symptoms. In people without symptoms, the test correctly identified 91 percent of positive samples and 96 percent of negative samples. The home test uses an analyzer that connects with a software application on a smartphone to help users perform the test and interpret results. Results are delivered in as little as 20 minutes via a person’s smartphone. “By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test, and find out their results in as little as 20 minutes,” FDA commissioner Stephen M. Hahn, MD, said in a statement released by the agency. “As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes.”

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Qiagen fully acquires NeuMoDx Molecular

January 2021—Qiagen has acquired the remaining 80.1 percent of NeuMoDx Molecular for $248 million in cash. The company purchased a 19.9 percent stake in NeuMoDx in 2018, along with the right to acquire the remaining stake. As part of the 2018 deal, Qiagen has distributed the NeuMoDx 288 and NeuMoDx 96 platforms in Europe and other markets outside the United States.

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Verichem Labs offers data reduction services

January 2021—Verichem Laboratories is offering its customers free access to the company’s online, web-based data reduction services. Designed for use with Verichem’s products, the service supports the necessary statistics required within the clinical laboratory to satisfy current CLIA and CAP requirements for the calibration verification of clinical assays.

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Streck launches rapid, modular qPCR instrument

January 2021—Streck has launched its Zulu RT, a rapid, modular qPCR instrument. The instrument consists of four independent thermal modules. A user can operate any combination of modules­—one module for a small sample set, leaving other modules for other users, or up to four modules simultaneously for a large sample set. It can perform a 40-cycle, six-channel real-time PCR in less than 20 minutes.

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BD FacsLyric 510(k) cleared with FacsDuet sample prep system

January 2021—BD received FDA 510(k) clearance for the BD FacsLyric flow cytometer integrated with the BD FacsDuet sample preparation system. Physical integration between the two instruments allows technicians to load samples and reagents onto the BD FacsDuet and obtain results once the samples are acquired and analyzed on the BD FacsLyric. Data integration using the BD FacsLink middleware solution offers bidirectional communication between the instruments and connectivity with laboratory information systems.

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COVID-19, flu combo test for home-collected samples

January 2021—The FDA authorized the first diagnostic test for at-home collection of patient samples to detect COVID-19 and influenza A and B. Quest Diagnostics’ RC COVID-19 +Flu RT-PCR Test for prescription use was authorized with Quest’s Self-Collection Kit for COVID-19 +Flu for individuals who are suspected of respiratory viral infection consistent with COVID-19 when home collection is determined to be appropriate by an individual’s health care provider.

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GenMark ePlex RP2 panel receives EUA

January 2021—GenMark Diagnostics received FDA emergency use authorization for its ePlex Respiratory Pathogen Panel 2. The test provides results in less than two hours for more than 20 viruses and bacteria that cause respiratory infections, including COVID-19, flu, bronchitis, and the common cold.

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Randox multiplex controls for respiratory disease

January 2021—Randox Laboratories has unveiled its Qnostics Multiplex Respiratory Pathogen Controls for respiratory diseases, including for SARS-CoV-2, influenza A and B, and respiratory syncytial virus. The RTX controls are used to monitor the full testing process, from extraction to amplification and detection, and are compatible with a majority of commercial and in-house assays.

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CDx to identify NTRK fusions in solid tumors approved

January 2021—The Food and Drug Administration approved the next -generation sequencing­­­–based FoundationOne CDx test (Foundation Medicine) as a companion diagnostic to identify fusions in neurotrophic receptor tyrosine kinase genes NTRK1, NTRK2, and NTRK3 in DNA isolated from tumor tissue specimens from patients with solid tumors eligible for treatment with larotrectinib (Vitrakvi, Bayer Healthcare Pharmaceuticals).

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TechLab to supply ASRs for SARS-CoV-2

January 2021—TechLab has partnered with New River Valley COVID-19 Task Force to expand future COVID-19 testing capacity. Under the agreement, the New River Health District, headquartered in Christianburg, Va., secures access to TechLab’s analyte-specific reagents for SARS-CoV-2 for $7 to $9 per use.

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FDA authorizes POC antibody test for COVID-19

January 2021—The FDA issued an emergency use authorization for the first serology antibody point-of-care test for COVID-19. The Assure COVID-19 IgG/IgM Rapid Test Device (Azure Biotech) was first authorized in July for emergency use by certain labs to help identify individuals with antibodies to SARS-CoV-2. The EUA has been reissued to authorize the test for POC use using fingerstick blood samples. The lateral flow assay is authorized for use with venous whole blood, serum, plasma, and fingerstick whole blood.

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Saliva-based COVID-19 assay gets EUA

January 2021—Fluidigm received emergency use authorization from the FDA for the Advanta Dx SARS-CoV-2 RT-PCR assay, an extraction-free, saliva-based test to detect nucleic acid from the SARS‑CoV‑2 virus. The test runs on the Fluidigm Biomark HD microfluidics platform, which can generate as many as 6,000 test results in one day.

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Verichem Labs reference materials

December 2020—Protein-based, ready-to-use liquid Matrix Plus Cholesterol Reference kits are available from Verichem Laboratories. The kits are designed to support overall system quality control and CLIA compliance and are for the calibration or calibration verification of cholesterol and uric acid wet assays on clinical testing systems. The materials contain esterified and free cholesterol from bovine serum. The standard kit with the sixth level F covers 12 concentration points; cholesterol concentrations range from 40 to 750 mg/dL and uric acid concentrations from 2 to 30 mg/dL. Active components are verified using standard reference materials from the National Institute of Standards and Technology. Shelf life is 21 months from the date of manufacture. Ready-to-use, liquid Total Protein and Albumin reference materials are also available. The combined Total Protein/Albumin Standard kit, along with the optional standalone Total Protein/Albumin Standard level F, are designed for the calibration and calibration verification of albumin and total protein assays on a wide number of clinical testing systems. The standards are prepared with human serum albumin and gamma-globulin serum proteins in a saline-based solution. Shelf life is 24 months from the manufacturing date.

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COVID-19, flu, RSV test available from ARUP

December 2020—ARUP Laboratories announced the availability of a combined test to detect and differentiate COVID-19, influenza, and/or respiratory syncytial virus in individuals with respiratory symptoms consistent with COVID-19. The test can be performed on specimens collected using a deep nasal swab or on specimens collected from the back of the throat and the front of both nostrils.

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Siemens, Novartis to develop assays

December 2020—Siemens Healthineers announced a master collaboration agreement with Novartis Pharma to design, develop, and commercialize diagnostic tests for therapeutic products across Novartis’ therapeutic pipeline. The initial program will focus on developing a serum neurofilament light chain immunoassay for patients with multiple sclerosis and other neurological diseases.

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FDA approves first treatment for COVID-19

December 2020—The FDA approved Gilead Sciences’ antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. Veklury should be administered only in a hospital or health care setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval.

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PCR Biosystems kit for Illumina NGS systems

December 2020—PCR Biosystems has introduced its NGSBIO Library Quant Kit for Illumina. The kit contains all the components necessary for accurate and sensitive quantification of DNA libraries prior to next-generation sequencing with Illumina platforms. The kit contains five DNA standards, primers specific to the p5 and p7 Illumina adapter sequences, a library dilution buffer, and qPCRBIO SyGreen Mix or qPCRBIO SyGreen Blue Mix. The blue qPCR mix contains a nonreactive dye to improve reaction mix visibility and is useful when using small reaction volumes or white plates.

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Qiagen launches NeuMoDx multiplex test

December 2020—Qiagen announced the European launch of the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test, which aims to help health care professionals identify and differentiate between patients with common seasonal respiratory infections and COVID-19. The multiplex PCR test detects and differentiates influenzas A and B, respiratory syncytial virus, and SARS-CoV-2 infections within 80 minutes.

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Genalyte rapid COVID-19 antibody test obtains EUA

December 2020—Genalyte announced that its SARS-CoV-2 Multi-Antigen Serology Panel received emergency use authorization from the FDA. The panel tests for IgM and IgG antibodies against 13 unique viral antigens and runs on the company’s Maverick diagnostic system, which provides results in 20 minutes. The test demonstrated 98 percent specificity and 96 percent sensitivity.

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FDA approves liquid biopsy NGS CDx

December 2020—The FDA approved the Guardant360 CDx assay (Guardant Health), a liquid biopsy companion diagnostic that also uses next-generation sequencing technology to identify patients with specific types of mutations of the epidermal growth factor receptor gene in a deadly form of metastatic non-small cell lung cancer. This is the first approval to combine NGS and liquid biopsy in one diagnostic test in order to guide treatment decisions.

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Eppendorf adjustable spacing pipettes

December 2020—Eppendorf released its Move It Adjustable Spacing Pipettes. Move It was designed for the synchronous pipetting of a series of samples between different vessel formats, such as between tubes and plates, without tubing connections between cone and piston-cylinder system. The format of microplates can be adjusted directly with the format limiters. For other sample tubes or tubes in holders, the cone spacing is selected by using the rotary knob.

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Magnolia launches Mission to Zero

November 2020—Magnolia Medical Technologies launched Mission to Zero to bring greater awareness to patient safety and antibiotic-associated risks caused by false-positive diagnostic test results for sepsis. Magnolia is launching the initiative by partnering with emergency departments, critical care units, clinical laboratories, and infection prevention teams within acute care hospitals. Each team member makes an individual pledge to participate, the company says, which allows all departments to work in tandem to ensure the best possible patient outcomes and experience are achieved.

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Bionano Prep SP Tissue and Tumor Kit

N0vember 2020—Bionano Genomics has launched the Bionano Prep SP Tissue and Tumor Kit, a DNA isolation kit developed for analysis of tumors and tissue with the company’s Saphyr system. The kit has been designed to simplify isolation of ultra-high-molecular-weight DNA from a variety of solid tumors and tissue types.

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ARUP shares formula for transport media

November 2020—ARUP Laboratories’ formula for ARUP Transport Media is now available to other laboratories. The formula is provided at the end of an article about an ARUP and University of Utah Health study in which the transport media was used for specimen collection (Hanson KE, et al. J Clin Microbiol. Accepted manuscript. Published online Aug. 12, 2020. doi:10.1128/JCM.01824-20).

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Alpha-Tec QC1 malaria slides

November 2020—Alpha-Tec Systems has released quality control slides containing smears of red blood cells infected with a mixture of ring-form, trophozoite, and schizont stages of Plasmodium falciparum. The slides are prefixed with methanol and are ready to stain with traditional Giemsa, Wright’s, or Field stains.

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FDA clears Simplexa flu A/B, RSV assay

November 2020—DiaSorin Molecular received FDA clearance for its Simplexa Flu A/B & RSV Direct Gen II kit. The assay can be run alone or alongside the Simplexa COVID-19 Direct kit, allowing for differential diagnosis of SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus.

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Bio-Rad controls for COVID-19 testing

November 2020—Bio-Rad Laboratories launched its in vitro diagnostics Virotrol SARS-CoV-2 and Viroclear SARS-CoV-2 positive and negative quality controls for use in antibody testing of SARS-CoV-2. The serological controls are available for in vitro assay procedures in the U.S. and are CE marked for IVD markets outside the U.S.

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CLSI guidelines

November 2020—The Clinical and Laboratory Standards Institute released two new guidelines, MM13: Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods, 2nd ed., and GP42: Collection of Capillary Blood Specimens, 7th ed.

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Agilent releases SureSelect RNA reagent kit

October 2020—Agilent Technologies released the Sure­Select XT HS2 RNA reagent kit. The kit enables users to accurately profile gene expression and detect RNA fusions using low-input FFPE samples and aims to significantly improve efficiency, especially in labs that process both DNA and RNA samples for next-generation–sequencing applications.

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Beckman SARS-CoV-2 IgM antibody test

October 2020—Beckman Coulter launched its Access SARS-CoV-2 Immunoglobulin M assay. The IgM antibody test demonstrated 99.9 percent specificity against 1,400 negative samples, the company reports, and 98.3 percent sensitivity at 15 to 30 days post-symptom onset. The test measures antibodies to the receptor binding domain of the spike protein, which the SARS-CoV-2 virus uses to bind to a human cell receptor.

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Promega launches Spectrum Compact CE

October 2020—Promega launched its benchtop capillary electrophoresis instrument, the Spectrum Compact CE system, developed in collaboration with Hitachi High-Tech. The integrated DNA analysis instrument enables life scientists in laboratories of all sizes to perform Sanger sequencing and fragment analysis at the bench.

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Remote live-cell imaging system

October 2020—CytoSmart Technologies launched an automated live-cell imaging system designed for long-term experiments, comparison studies, and large laboratory teams. The CytoSmart Multi Lux consists of four mini digital microscopes supported by automated image analysis software. Multi Lux technology enables users to run up to four experiments simultaneously from inside the incubator. Automated image analysis and immediate visualization of the results are accessible remotely via the CytoSmart cloud.

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Bio SB Fast Mohs PolyDetector Plus for IHC

October 2020—Bio SB launched its Fast Mohs PolyDetector Plus Detection System, a highly sensitive nonbiotin monovalent Fab micropolymer IHC detection system for the detection of IVD antibodies for melanoma, basal cell carcinoma, and squamous cell carcinoma. It is intended for the detection of difficult nuclear targets such as androgen receptor, Ki-67, p40, p63, and SOX10.

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Verichem standards kits

October 2020—A ready-to-use microprotein standard kit is available from Verichem Laboratories. The kit is intended for the calibration verification of total protein and albumin concentrations in urine and cerebral spinal fluid. The five-level set provides 10 certified concentrations in an azide-free liquid format. The kit is suitable for use with turbidimetric and colorimetric testing methods and incorporates human protein components. Shelf life is 24 months from the manufacturing date when stored at 2° to 8°C.

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OGT’s CytoSure v3 improves reporting rate

October 2020—According to a recent NPJ Genomic Medicine paper (Jezkova J, et al. 2020;5:28), Oxford Gene Technology’s CytoSure Constitutional v3 array design significantly improved reporting rate and proved to be a powerful tool for the detection of small pathogenic intragenic deletions and duplications in developmental disorder research. The paper was led by a consortium of National Health Service genomic medicine centers in the U.K.; it compared the enhanced exon-level gene coverage of the v3 array with a conventional array design.

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Bruker introduces MALDI-2 source on TimsTOF Flex

September 2020—Bruker announced an advance in matrix-assisted laser desorption ionization with the launch of its MALDI-2 post-ionization (PI) source, now available as an option on the TimsTOF Flex ESI/MALDI mass spectrometer. The MALDI-2 technology can offer one or two orders of magnitude higher sensitivity for many small molecules and lipids, Bruker said. MALDI-2 increases the applications range of MALDI mass spectrometry and imaging even further. Bruker launched additional TIMS/PASEF-enabled 4D proteomics methods that leverage the large-scale, real-time availability of accurate collision cross sections (CCS) for thousands of measured peptides per 4D nanoLC-CCS-MS/MS run.

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Luminex receives EUA for COVID-19 antibody test

September 2020—Luminex Corp. announced that the FDA issued an emergency use authorization for the company’s xMAP SARS-CoV-2 Multi-Antigen IgG Assay. The assay demonstrated specificity of 100 percent in human serum and greater than 99 percent in human plasma, with sensitivity greater than 96 percent for human serum and plasma (>14 days post-symptom onset) in clinical studies.

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Microbiologics expands viral capabilities for SARS-CoV-2

September 2020—Microbiologics has expanded its custom virology solutions in its renovated virology services lab to include biosafety level 3 antiviral services. With these new capabilities, the company has launched a menu of cell-based services for SARS-CoV-2 to assist assay developers, evaluate therapeutic solutions and vaccines, and provide inactivated intact virus to researchers and diagnostic companies.

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Sofia SARS Antigen FIA receives CE mark

September 2020—The Sofia SARS Antigen Fluorescent Immunoassay received the CE mark for use with the Sofia and Sofia 2 instruments. The CE mark allows Quidel to market and sell the Sofia SARS Antigen FIA in Europe and in countries that accept the CE mark. The test provides results in 15 minutes.

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