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New pathology lab products and industry news

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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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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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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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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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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