Marketplace Directory

November 2020—Thermo Fisher Scientific announced the availability of its Oncomine Myeloid Assay GX, the first in a series of clinical research assays available from the company’s new portfolio of hematology-oncology assays for the Ion Torrent Genexus System.

November 2020—The FDA has issued an emergency use authorization for Visby Medical’s single-use personal PCR device, a rapid test for detecting COVID-19.

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).

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.

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.

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.

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.

November 2020—Qiagen plans to launch a test that can detect SARS-CoV-2 antigens in people with active infections in less than 15 minutes and process, on average, 30 swab samples per hour using a small digital detection system. The test is expected to become available in the fourth quarter of this year.

November 2020—Hologic’s Aptima SARS-CoV-2 assay, which initially received FDA emergency use authorization in May, is now authorized for testing people without symptoms or other reasons to suspect COVID-19 infection.

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.

October 2020—Diazyme Laboratories announced it received FDA emergency use authorization for the Diazyme DZ-Lite SARS-CoV-2 IgM CLIA test. The test is highly sensitive and specific and does not cross-react with the HKU1, OC43, NL63, and 229E coronavirus strains.

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.

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.

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.

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.

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.

October 2020—The FDA issued an emergency use authorization to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 infection, the agency says.

October 2020—Novodiax released two rapid ihcDirect reagent test kits for in vitro diagnostic use, ihcDirect CK19 and ihcDirect CK20.

October 2020—ARUP Laboratories now offers COVID-19 testing using saliva specimens. The laboratory will perform the test only on saliva specimens collected using an ARUP collection kit with a health care provider present.

October 2020—Accumen announced a partnership with medical equipment manufacturer Spectrum Solutions to provide saliva testing kits for detecting COVID-19.

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.

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.

September 2020—Power of Process, an international learning and development company, and LabVine have partnered to provide an online laboratory performance improvement program, hosted on Labvinelearning.com. The program consists of the Power of Process Champion and Power of Process Master courses followed by a three-month workplace component to embed learning.

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.

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.

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.

September 2020—Public Health England evaluated four commercial immunoassay tests used for the detection of SARS-CoV-2 antibodies and available in the United Kingdom.

September 2020—GenMark Diagnostics announced that its ePlex Respiratory Pathogen 2 Panel is available for U.S. commercial distribution and clinical use.

September 2020—EliTechGroup launched its Aerospray Cytology Slide Stainer Cytocentrifuge, which automates the preparation and staining of liquid-based cytology specimens to facilitate the examination of an array of cell differentiations using Papanicolaou staining techniques. The device performs two functions of sample preparation through cytocentrifugation and sample staining. It maximizes cell recovery to the slide through the use of its Cytopro Rotor, eliminates cross-contamination with an application of fresh stain for each slide, and provides programmable regressive and progressive staining capabilities that can be stored in memory.

September 2020—Oxford Gene Technology, a Sysmex Group company, announced that Sysmex sales and support services are now available in China and Spain for Cytocell customers. The expansion involves Sysmex Shanghai, Sysmex Hong Kong, and Sysmex Espana.

September 2020—DiaSorin Molecular announced that its Simplexa Flu A/B & RSV Direct Gen II kit has received the CE mark. The kit delivers continued comprehensive strain coverage and accurate detection in a sample-to-answer format that does not require extraction.

September 2020—Diaceutics announced two partnerships, with Targos Molecular Pathology and HistoCyte Laboratories, on its DXRX platform, an end-to-end solution for the development and commercialization of precision medicine diagnostics.

September 2020—Diazyme Laboratories received FDA emergency use authorization for the Diazyme DZ-Lite SARS-CoV-2 IgG CLIA test.

September 2020—NeuMoDx Molecular has received the CE mark for its NeuMoDx HPV Assay, a fully automated, in vitro real-time PCR-based assay for the qualitative detection of high-risk types of human papillomavirus DNA in cervical specimens. It specifically identifies HPV 16 and 18 while concurrently detecting 13 other common high-risk types at clinically relevant infection levels.

September 2020—Integrated DNA Technologies and Sherlock Biosciences have entered into a strategic collaboration to enable large-scale manufacturing of the Sherlock CRISPR SARS-CoV-2 kit for the detection of COVID-19. IDT will supply several components, including the Cas13a enzyme, on which the test is based, as well as a CRISPR RNA and primer mix.

September 2020—Qiagen has launched the QIAseq SARS-CoV-2 Primer Panel for next-generation sequencing of the novel coronavirus genome and integrated analysis and interpretation workflows for insights into the evolution and spread of the virus.

September 2020—The FDA has issued emergency use authorization for Abbott’s BinaxNow COVID-19 Ag Card rapid test for the detection of COVID-19 infection.

September 2020—BioMérieux received emergency use authorization by the FDA for its Vidas SARS-CoV-2 IgM and Vidas SARS-CoV-2 IgG serology tests.

August 2020—Verichem Laboratories announced the availability of its Enzyme ER Verifier Kit designed for the calibration verification of wet chemistry testing systems. The multianalyte, six-level kit of liquid stable materials is composed of nine clinical enzyme components—amylase, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, cholinesterase, creatinine kinase, gamma-glutamyl transferase, lactate dehydrogenase, and lipase—covering 54 activities.

August 2020—Beckman Coulter has received FDA emergency use authorization for its Access SARS-CoV-2 IgG assay, a qualitative immunoassay that detects IgG antibodies directed to the receptor binding domain of the spike protein of the novel coronavirus. It uses immobilized virus antigens on magnetic particles to capture IgG antibodies from patient blood or serum samples. The test has a confirmed 100 percent positive percent agreement and 99.6 percent negative percent agreement.

August 2020—Alpha-Tec Systems has partnered with Microbix to provide whole-genome molecular REDx control products for SARS-CoV-2 and human papillomavirus to qualify and validate the elution, extraction, amplification, and detection steps of nucleic acid testing workflows.

August 2020—Randox Laboratories has unveiled cytokine testing for COVID-19 risk stratification and treatment monitoring. The tests look for the presence of cytokines and are performed using Randox’s Biochip technology, which can detect up to 12 cytokines and growth factors from a single patient sample. The testing menu includes 26 cytokines across four biochip panels.

August 2020—DiaSorin Molecular announced it has received the CE mark 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 up to 21 days old.

August 2020—Microbiologics announced the launch of two products for COVID-19 quality control and research—a research use only protein-coated RNA process control and an IVD control with pooled gene targets.

August 2020—Illumina announced that the FDA issued an emergency use authorization for the Illumina COVIDSeq test, a high-throughput, sequencing-based, in vitro diagnostic workflow enabling the detection of SARS-CoV-2.

August 2020—The FDA reissued on July 18 an emergency use authorization to Quest Diagnostics to authorize its Quest SARS-CoV-2 rRT-PCR test for use with pooled samples containing up to four individual swab specimens collected under observation. It is the first COVID-19 diagnostic test to be authorized for use with pooled samples.

August 2020—Becton Dickinson announced that the FDA granted emergency use authorization to the BD Veritor Plus System for Rapid Detection of SARS-CoV-2 Assay, a point-of-care diagnostic test for use with the BD Veritor Plus System.

August 2020—Flagship Biosciences launched a clinical diagnostics immuno-oncology service, TissueInsight, which provides CLIA-reportable PD-L1 results along with data about the tumor microenvironment, including information on tumor infiltrating lymphocytes and macrophages.

July 2020—The Food and Drug Administration approved the combination of nivolumab (Opdivo, Bristol-Myers Squibb) plus ipilimumab (Yervoy, Bristol-Myers Squibb) and two cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations. Efficacy was investigated in CHECKMATE-9LA, a randomized, open-label trial for patients with metastatic or recurrent NSCLC. Patients were randomized to receive either the combination of nivolumab plus ipilimumab and two cycles of platinum-doublet chemotherapy (n = 361) or platinum-doublet chemotherapy for four cycles (n = 358). The trial demonstrated a statistically significant benefit in overall survival for patients treated with nivolumab plus ipilimumab plus chemotherapy compared with those who received chemotherapy. Median overall survival was 14.1 months (95 percent CI: 13.2, 16.2) versus 10.7 months (95 percent CI: 9.5, 12.5), (HR 0.69; 96.71 percent CI: 0.55, 0.87).

July 2020—Sarstedt introduced its Refill Revolution, a pipette tip refill system. The system is made up of a reusable box, SingleRefills, StackPacks, and bagged tips. The central box is compact, closes tightly during transport, storage, and autoclaving, and is easily refilled. Lightweight SingleRefills are sealed to protect tips from contamination during transfer to the box. StackPacks reduce plastic materials and packaging volume and are stable, with sturdy trays anchored to one another to prevent spills. Bulk tip bags feature a tamper-evident seal and zip closure.

July 2020—Roche announced that the FDA has issued an emergency use authorization for the Elecsys IL-6 test, which measures levels of the biomarker interleukin 6 in human serum or plasma. The assay can be used to assist in identifying severe inflammatory response in patients with confirmed COVID‑19 illness to aid in determining the risk of intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing.

July 2020—Hemex Health (Portland, Ore.) launched the company’s Gazelle diagnostic platform, which integrates artificial intelligence with automated, miniaturized electrophoresis and internal and cloud-based data storage. The battery-operated platform uses an Android cell-phone charger and does not require a cold chain.

July 2020—Epredia and Lunaphore Technologies SA announced they have entered into a distribution agreement. Under the terms of the agreement, Epredia has been appointed the exclusive distributor of the LabSat Research platform in the U.S., U.K., and Germany, where Epredia will start to distribute the product, as well as Japan, where commercialization will begin in 2021. In these countries, Epredia will also provide service for the Lunaphore instruments.

July 2020—Oxford Immunotec announced the release of the research use only T-Spot Discovery SARS-CoV-2 test kit.

July 2020—Bio-Rad Laboratories announced that its CFX96 Dx Real-Time PCR System has been listed with the FDA for IVD testing and may be used to help in the diagnosis of COVID-19.

July 2020—Randox Laboratories ToRCH quality controls for infectious disease testing in newborns have been granted the CE mark.

June 2020—Siemens Healthineers announced it is shipping worldwide its CE-marked, laboratory-based total antibody test to detect the presence of SARS-CoV-2 IgM and IgG antibodies in blood. The test has demonstrated 100 percent sensitivity and 99.8 percent specificity and is available on the Atellica Solution immunoassay analyzer and the Advia Centaur XP and XPT analyzers. The test detects antibodies to a spike protein on the surface of the SARS-CoV-2 virus. “Studies indicate that certain (neutralizing) antibodies to the spike protein can disarm SARS-CoV-2, presumably by interfering with the ability of the virus to bind, penetrate, and infect human cells,” according to a press release from the company. “Multiple potential vaccines in development for SARS-CoV-2 include the spike protein within their focus.”

June 2020—Abbott’s i-Stat CG4+ and Chem8+ cartridges have received FDA clearance. The i-Stat CG4+ cartridge with the i-Stat 1 System is intended for use in the in vitro quantification of pH, PO2, PCO2, and lactate in arterial or venous whole blood in point-of-care or clinical laboratory settings. With the i-Stat CG4+, clinicians may assess the respiratory status of a patient or determine the presence of hyperlactatemia to inform the risk stratification of a patient diagnosed with sepsis.

June 2020—ARUP Laboratories announced that it is making a second COVID-19 IgG antibody test available nationwide.

June 2020—Bio-Rad Laboratories announced it was granted FDA emergency use authorization for the company’s SARS-CoV-2 Total Ab test. The test has also met the CE mark requirements for Europe.

June 2020—Rheonix announced it has received FDA emergency use authorization for the Rheonix COVID-19 MDx Assay. The fully automated test enables detection of SARS-CoV-2 directly from respiratory samples and runs on the Rheonix Encompass MDx workstation. The workstation is suitable for use in low- to medium-throughput labs and enables same-day results.

June 2020—Nova Biomedical launched its Stat EMS Basic blood testing system for ambulance and emergency care in countries that require the CE mark. Stat EMS Basic measures fingerstick capillary lactate, glucose, ketone, hemoglobin, and hematocrit in six to 40 seconds.

June 2020—Ortho Clinical Diagnostics announced its COVID-19 total antibody test received the CE mark. The test offers excellent performance, with 100 percent specificity and sensitivity, and detects all COVID-19 related antibodies—IgA, IgM, and IgG.

June 2020—Aalto Bio Reagents announced the availability of its range of recombinant SARS-CoV-2 spike (S) proteins for diagnostic test manufacturers, vaccine developers, and researchers.

June 2020—PerkinElmer announced that the FDA has provided emergency use authorization for Euroimmun’s Anti-SARS-CoV-2 ELISA (IgG) serology test. Clinical laboratories certified to perform high-complexity tests under CLIA can use this ELISA for the detection of antibodies of the immunoglobulin class G.

June 2020—Hologic announced it has received emergency use authorization from the FDA for its Aptima SARS-CoV-2 assay to detect the novel coronavirus.

June 2020—Quidel announced it has received emergency use authorization for the Lyra Direct SARS-CoV-2 Assay from the Food and Drug Administration to allow direct sample processing.

May 2020—Thermo Fisher Scientific announced that its Cascadion SM clinical analyzer is commercially available in the U.S. with the Cascadion SM 25-Hydroxy Vitamin D assay. The Cascadion system analyzes samples directly from qualified primary blood collection tubes. The Cascadion SM 25-Hydroxy Vitamin D Assay incorporates fully barcoded components, all traceable to a specific result.

May 2020—Nova Biomedical announced a webinar, titled “COVID-19 Bedside Glucose Management: Risk of Ascorbic Acid and Hematocrit Interference,” to help inform and support health care workers treating COVID-19 patients. The webinar, led by Charbel Abou-Diwan, PhD, director of Nova Biomedical’s medical and scientific affairs, examines the risk of inaccurate glucose meter results due to interference from ascorbic acid and anemia.

May 2020—MedTest Dx announced the availability of its Pointe Scientific–branded assay for the highly sensitive quantification of G6PD in whole blood.

May 2020—Biocare Medical launched seven novel IVD IHC antibody markers for clinical diagnostics and research applications. This launch focuses on several immuno-oncology markers, critical in aiding early-stage cancer drug developments and patient treatment.

May 2020—The CAP has released a new proficiency testing program for the detection of SARS-CoV-2 by nucleic acid amplification testing.

May 2020—EKF Diagnostics has launched in the United States its Stat-Site WB dual-use whole blood β-ketone and glucose meter for professional use in the management of diabetes. The CLIA-waived handheld analyzer quantitatively measures β-ketone (beta-hydroxybutyrate) from fresh capillary and venous whole blood in 10 seconds and delivers quantitative measurements in five seconds for glucose in fresh capillary, venous, and neonatal whole blood. The system has a measurement range of 0.1–8.0 mmol/L for β-ketone and 0.5–33.3 mmol/L for blood glucose. Its hematocrit range is 10–70 percent for β-ketone and 20–70 percent for blood glucose.

May 2020—BD announced that its BD Kiestra ReadA is device listed with the FDA. The BD Kiestra ReadA incubation and imaging system, which is available as a standalone instrument, aims to help improve operational efficiency in clinical microbiology laboratories by automating routine plate management tasks and delivering accuracy through standardized digital image acquisition.

May 2020—MilliporeSigma has been selected by Swedish molecular diagnostics company Elypta as the contract manufacturer for Elypta’s clinical diagnostic liquid biopsy kits. The kits analyze metabolites deregulated in several cancer types and will initially be made available for research use only. They are intended for mass spectrometry systems and will allow qualified researchers to measure the full spectrum of human glycosaminoglycans in body fluid samples.  

May 2020—Viracor Eurofins was granted FDA emergency use authorization for the Viracor SARS-CoV-2 assay, a real-time polymerase chain reaction test intended for the qualitative detection of SARS-CoV-2 viral RNA in nasopharyngeal swab, nasal swab, nasopharyngeal wash, nasal wash, oropharyngeal swab, and bronchoalveolar lavage from individuals suspected of having COVID-19.

May 2020—Ortho Clinical Diagnostics announced the FDA granted emergency use authorization to its second COVID-19 antibody test—the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test. The test demonstrated 100 percent specificity and runs on Ortho’s high-throughput, fully automated analyzers including its Vitros XT 7600 integrated system, Vitros 3600 immunodiagnostic system, Vitros 5600 integrated system, and it will soon be available on Vitros ECi/ECiQ immunodiagnostic systems.

May 2020—Thermo Fisher Scientific has signed an agreement with Janssen Biotech to co-develop a companion diagnostic in oncology. The diagnostic will support clinical trial enrollment worldwide.

May 2020—Horizon Discovery Group announced its cGMP-compliant CHOsource platform has played a key role in generating a stable cell line for the development of an immunotherapy for autoimmune diseases. Horizon’s Chinese hamster ovary cells delivered high yields of monoclonal antibody for LAG-3 immunotherapy, the company reported in a press statement, enabling Immutep and Batavia Biosciences to reach a milestone in the preclinical development of the compound.

April 2020—Sylvia L. Asa, MD, PhD, consultant in endocrine pathology, University Hospitals Cleveland Medical Center and University Health Network Toronto, and professor of pathology, Case Western Reserve University, served as an editor of two recently published books related to pathology and is a coauthor of the first book in series five of the AFIP Atlas of Tumor and Non-Tumor Pathology series. Dr. Asa showcased these books at this year’s USCAP meeting in Los Angeles. Art Gallery of Pathology (ARP Press), created by Tim-Rasmus Kiehl, MD, and edited by Dr. Asa, explores the use of human pathology samples as they are used to create art. Dr. Kiehl worked as a neuropathologist at University Health Network in Toronto.

April 2020—Randox announced that its Randox STI assay has received the CE mark. The multiplex assay detects 10 STIs, including co-infections, from a single patient sample. It tests simultaneously for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma genitalium, Treponema pallidum, HSV-1, HSV-2, Haemophilus ducreyi, Mycoplasma hominis, and Ureaplasma urealyticum.

April 2020—Becton Dickinson and Babson Diagnostics, a diagnostic blood testing company, announced a long-term strategic partnership agreement to bring laboratory-quality, small-volume blood collection to retail pharmacies. BD’s capillary specimen collection devices, in development, are designed to enable the collection of laboratory-quality specimens without the need to access a vein and are for use in health care settings without a trained phlebotomist, such as retail pharmacies, physician offices, urgent care centers, and skilled nursing facilities. Babson’s offerings include proprietary automated sample handling and analytical technologies, which are also in development.

April 2020—Leica Biosystems launched the Aperio GT 450, its next-generation digital pathology scanner. The research-use-only Aperio GT 450 offers continuous rack loading with priority scanning and takes 32 seconds to scan a 15 mm × 15 mm tissue area on a pathology slide at 40× magnification with a throughput of 81 slides per hour. The system’s slide racks are compatible with other Leica Biosystems products.

April 2020—The FDA authorized the marketing of AmplideX Fragile X Dx and Carrier Screen Kit (Asuragen). It is the first test, according to the FDA, to detect Fragile X syndrome, the most common known cause of inherited developmental delay and intellectual disability. Additionally, this test is intended for use in adults who may be carriers of genetic alterations in the FMR1 gene.

April 2020—The FDA approved neratinib (Nerlynx, Puma Biotechnology) in combination with capecitabine for adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2–based regimens in the metastatic setting.

April 2020—ProPath announced that New England Tissue Issue, a dermatopathology practice in Fall River, Mass., has joined the ProPath family of companies. The partnership will allow 8 million patients from NETI’s catchment area in-network access to ProPath’s esoteric testing.

April 2020—Thermo Fisher Scientific launched the Thermo Scientific Multidrop Pico 1 and Pico 8 Digital Dispensers, designed to enable assay miniaturization, boost productivity, and improve accuracy of results. The systems dispense reagent volumes between 11 pL and 200 µL in any well and are suitable for a broad array of low-volume applications, including quantitative polymerase chain reactions, dose response curves, drug screening assays, serial dilutions, genotyping reactions, and enzyme-linked immunosorbent assays.

April 2020—Streck released CE-marked ARM-D kits for the OXA, MCR, and TEM/SHV/GES gene families.

April 2020—Roche announced that the European Commission has approved Venclyxto (venetoclax) in combination with Gazyvaro (obinutuzumab) for the treatment of adult patients with previously untreated chronic lymphocytic leukemia.

April 2020—Siemens Healthineers announced it was selected by Quest Diagnostics to be Quest’s preferred supplier for immunoassay testing. As part of the multiyear agreement, Quest will deploy up to 120 Atellica Solution immunoassay analyzers in 19 esoteric and core laboratories in the United States.

April 2020—The U.S. Food and Drug Administration approved Palforzia (Peanut [Arachis hypogaea] Allergen Powder-dnfp) to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts. Treatment with Palforzia (Aimmune Therapeutics) may be initiated in individuals ages four through 17 years with a confirmed diagnosis of peanut allergy and may be continued in individuals four years of age and older. Those who take Palforzia must continue to avoid peanuts in their diets.

April 2020—Fujirebio Diagnostics received FDA clearance of its Lumipulse G1200 CA19-9-N chemiluminescent enzyme immunoassay for use on the Lumipulse G1200 system. The assay provides the quantitative measurement of CA 19-9 in human serum or plasma and is for use as an aid in the management of patients diagnosed with cancer of the exocrine pancreas.

April 2020—Agilent Technologies introduced three microarrays to meet the needs of cytogenetic laboratories conducting prenatal and postnatal research.

April 2020—Epredia introduced its SlideMate Pro slide printing system at USCAP, Feb. 29–March 5, in Los Angeles. It was the first time the company attended USCAP; Epredia was established in July 2019 through an acquisition by PHC Group from Thermo Fisher Scientific.

April 2020—Thermo Fisher Scientific introduced the Ion Torrent CarrierSeq ECS Kit for the Ion GeneStudio S5 system. The next-generation-sequencing–based solution consolidates a multiplatform approach into a single solution.

April 2020—The Clinical and Laboratory Standards Institute has published its annually updated antimicrobial susceptibility testing supplement, “M100: Performance Standards for Antimicrobial Susceptibility Testing, 30th ed.” M100 is available as part of a package with either “M02: Performance Standards for Antimicrobial Disk Susceptibility, 13th ed.” or “M07: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically, 11th ed.,” or all three documents can be purchased together. A free, read-only web version of M100 is available at https://j.mp/2UEHgtj.

March 2020—Verichem Laboratories announced the availability of its ethanol standard kits. The protein-based, liquid standards are intended for calibration or calibration verification of serum ethanol test systems. The product also contains lactate, salicylate, and acetaminophen in a known linear relation and may be used to determine the linearity, sensitivity, and reportable range for these analytes as well. The reference materials are free of surfactants, glycols, azide, and other interfering substances. The kit contains a six-level set with 5.0 mL of each level.

March 2020—The FDA issued an emergency use authorization for the Centers for Disease Control and Prevention’s 2019-nCoV Real-Time RT-PCR Diagnostic Panel. This test had been limited to use at CDC laboratories; the authorization allows the use of the test at any CDC-qualified lab in the United States.

March 2020—Thermo Fisher Scientific launched the Applied Biosystems Axiom Propel Genotyping workflow designed to allow laboratories to scale up easily by eliminating the need for multiple liquid handlers and lower running costs through the use of reusable dispensing cassettes and minimal labware.

March 2020—Oxford Gene Technology launched its SureSeq CLL + CNV Panel, a next-generation sequencing panel designed to detect 12 key genes and five chromosomal regions implicated in chronic lymphocytic leukemia progression.

March 2020—Roche announced the commercial availability of a quantitative Adenovirus Test for use with the Cobas Omni utility channel on the Cobas 6800/8800 systems in countries accepting the CE mark. The test aims to help health care professionals better monitor and manage severely immunocompromised transplant patients at risk of infections.

March 2020—Qiagen announced the CE marking and launch of its Therascreen PIK3CA RGQ PCR Kit in Europe as an aid in identifying breast cancer patients with a PIK3CA mutation. The Therascreen PIK3CA test was approved in 2019 by the FDA and launched in the U.S. as a companion diagnostic test for Piqray (alpelisib).

March 2020—Agilent Technologies introduced the SureSelect XT HS2 DNA Kit, designed to address key challenges that laboratories encounter when preparing DNA sequencing libraries for their research.

March 2020—Beckman Coulter’s Access PCT assay has received FDA 510(k) clearance and is available for sale in the United States. The assay enables health care providers to integrate procalcitonin testing analysis into their routine sepsis workups on core laboratory analyzers, as a primary or reflex test programmed through Beckman Coulter’s Remisol Advance middleware. Test results are available in less than 20 minutes.

March 2020—Thermo Fisher Scientific and NanoPin Technologies have entered into a collaborative relationship to advance blood-based infectious disease detection technology through the development of highly sensitive liquid chromatography-mass spectrometry–based workflows.

March 2020—Biodesix and Streck announced a regulatory cooperation agreement that will further enable the companies to pursue FDA approval for diagnostic testing services and specimen collection products.

March 2020—Hamilton Storage introduced the Lab­Elite DeFroster for removing frost on tube racks. The unit automatically draws a single rack into one end where mechanical brushes and a liquid solvent remove frost in less than 10 seconds, then the rack is sent out the opposite end. The platform will not warm samples more than 15°C, ensuring sample integrity, can operate in a cold room environment ranging from +10°C to +30°C, and is mobile, allowing users to perform work while using battery power. The defroster is compatible with tube types up to 90 mm high.

February 2020—Olympus and Ultivue, a developer of tissue biomarker identification and quantification assays for translational research, have entered into a comarketing agreement. The partnership will provide a solution for fluorescent multiplexing by combining the Olympus Slideview VS200 automated slide scanner with Ultivue’s proprietary InSituPlex DNA barcoding and staining technology to provide quantitative colocalization analysis in fluorescent whole slide images.

February 2020—SeraCare Life Sciences launched genomic DNA and formalin-fixed, paraffin-embedded reference materials for tumor mutational burden measurement by next-generation sequencing assays. SeraCare collaborated with Friends of Cancer Research and International Quality Network for Pathology in the development and evaluation of a range of gDNA and FFPE-based TMB reference materials across different targeted NGS panels, sequencing platforms, and bioinformatics analysis pipelines.

February 2020—DiaSorin Molecular has received FDA clearance for its Simplexa VZV Swab Direct assay. The CLIA moderate-complexity assay is designed for use on the Liaison MDX instrument to detect varicella-zoster virus DNA from cutaneous and mucocutaneous swab specimens. The assay complements the company’s Simplexa VZV Direct kit, which is for use with cerebrospinal fluid samples.

February 2020—Applied BioCode has received FDA 510(k) clearance for its BioCode Respiratory Pathogen Panel for use on the company’s BioCode MDx-3000 system. The panel tests nasopharyngeal swabs for common viruses and bacteria, including influenza A and subtypes H1, H1N1 2009pdm, and H3; influenza B; respiratory syncytial virus A/B; parainfluenza virus types 1–4; human metapneumovirus A/B; adenovirus; rhinovirus/enterovirus; coronavirus (229E, NL63, OC43, and HKU1); Mycoplasma pneumoniae; Chlamydia pneumoniae; and Bordetella pertussis.

February 2020—The U.S. Food and Drug Administration announced the approval of Ervebo (Merck), the first FDA-approved vaccine for the prevention of Ebola virus disease, caused by Zaire ebolavirus, in people 18 years of age and older. Ervebo is administered as a single-dose injection and is a live, attenuated vaccine that has been genetically engineered to contain a protein from the Zaire ebolavirus.

February 2020—Roche and Sarepta Therapeutics signed a licensing agreement providing Roche exclusive commercial rights, outside the United States, to SRP-9001 (AAVrh74.MHCK7.micro-dystrophin), Sarepta’s investigational gene therapy for Duchenne muscular dystrophy. Under the terms of the agreement, Sarepta will receive an upfront payment of $750 million in cash and $400 million in equity. In addition, Sarepta is eligible to receive regulatory and sales milestones, and royalties on net sales. Roche and Sarepta will equally share global development expenses. As part of the agreement, Roche also obtains an option to acquire ex-U.S. rights to certain future DMD-specific programs from Sarepta, in exchange for separate milestone and royalty considerations, and cost sharing.

February 2020—Qiagen introduced QIAseq Multimodal Panels, which offer a consolidated workflow to enrich DNA variants, RNA fusions, and gene expression levels from a single sample, with input as low as 10 ng of total nucleic acid. It reduces the workflow to approximately nine hours, the company reports, by eliminating the need for two workflows from separate DNA and RNA samples.

February 2020—Baebies announced that its Finder platform is CE marked as an in vitro diagnostic device and commercially available in Europe and other countries that recognize the CE mark. The platform includes an instrument and a cartridge, which tests for glucose-6-phosphate dehydrogenase from 50 μL of whole blood. Features of the platform include an eight-inch-wide footprint, preloaded consumables with all necessary reagents, and a turnaround time of approximately 15 minutes from sample introduction.

February 2020—Genomenon announced a partnership with Sophia Genetics that includes incorporating Genomenon’s Mastermind genomic search engine into the Sophia platform and the Alamut suite.

February 2020—Eppendorf has launched 25-mL conical tubes. It is the same diameter as a conventional 50-mL conical tube and comes with either the SnapTec snap cap or screw cap, both of which have high centrifugation stability. The SnapTec cap allows for single-handed opening and closing of the cap. The wide opening of the tube, combined with the lower height, is designed to offer easy sample access.

February 2020—Codexis, a protein engineering company, announced a license agreement to provide Roche with its EvoT4 DNA ligase high-performance molecular diagnostic enzyme. The enzyme was developed using Codexis’ CodeEvolver protein engineering platform and is expected to be incorporated into Roche’s next-generation sequencing library preparation kits and other sequencing products. The license grants Roche worldwide rights to include the EvoT4 DNA ligase in its nucleic acid sequencing products and workflows.

February 2020—DriBank Labs announced the availability of its DriBank system for preserving, storing, and shipping laboratory samples. The system preserves small (≤ 3 g or 50 µL) laboratory biological samples at room temperature (20˚C) for up to six months using desiccants contained inside a replaceable and rechargeable cartridge, eliminating the need for chemical fixatives or refrigerants. It accepts samples in a variety of media including microscope slides, microcentrifuge tubes, cell culture dishes, swabs, and others.

February 2020—NeuMoDx Molecular and Sentinel Diagnostics announced a partnership to develop diagnostic assays for the NeuMoDx 96 and 288 molecular systems. Sentinel’s real-time PCR assays will be adapted to the NeuMoDx 96 and 288 molecular systems and will incorporate Sentinel’s STAT-NAT technology, which provides the ability to stabilize the activity of a PCR mix, allowing room-temperature storage and transport. The test menu pipeline for the systems will include assays to detect and monitor post-transplant infections, parasitic and hospital-acquired infections, and respiratory infections, and for pharmacogenetics applications.

February 2020—ArcherDX announced a nonexclusive, multiyear partnership with Illumina intended to broaden access of next-generation-sequencing­–based oncology testing, including companion diagnostics for therapeutic selection, personalized monitoring, and recurrence surveillance IVD tests, upon FDA approval.  

February 2020—Horizon Discovery Group went live with a new website and ecommerce system, horizondiscovery.com. Features of the website are improved navigation, including sophisticated gene-based search capabilities and advanced filtering, an intuitive, streamlined purchasing and quotation system, and comprehensive technical support and educational content.

February 2020—Vidan Diagnostics announced the availability of its β-Hydroxybutyrate 21FS prefilled reagent kits, for the quantitative in vitro determination of beta-hydroxybutyrate in serum or plasma, for use with Abbott Architect and Beckman Coulter AU systems.

February 2020—Curetis announced it has received FDA 510(k) clearance to market its Unyvero LRT Lower Respiratory Tract application cartridge for use with bronchoalveolar lavage samples to diagnose lower respiratory tract infections such as pneumonia.

February 2020—The FDA authorized marketing of the Cobas VivoDx MRSA (Roche Molecular Systems) diagnostic test based on bacterial viability and novel technology to detect methicillin-resistant Staphylococcus aureus bacterial colonization. The Cobas VivoDx MRSA test uses a new bacteriophage technology based on bioluminescence to detect MRSA from nasal swab samples in as few as five hours compared with 24 to 48 ...

February 2020—Myriad Genetics announced that the FDA has approved BRACAnalysis CDx for use as a companion diagnostic to identify patients with metastatic pancreatic cancer who have a germline BRCA mutation and are candidates for treatment with PARP inhibitor olaparib (Lynparza, AstraZeneca). BRACAnalysis CDx is the first FDA-approved genetic test for this indication, the company reports.

February 2020—Verichem Laboratories announced the availability of its HDL Cholesterol Verifier kit intended for the calibration verification of HDL and LDL cholesterol assays. The kit contains high-density and low-density lipoprotein cholesterol from human serum in a ready-to-use, liquid stable format that is free of surfactants, glycols, and azide.

February 2020—Karius announced that JAMA Oncology published a clinical study showing that the Karius test detected bloodstream infections before the onset of clinical symptoms in high-risk pediatric patients with relapsed or refractory leukemia (Goggin KP, et al. Epub ahead of print Dec. 19, 2019. doi:10.1001/jamaoncol.2019.4120). The study was performed by researchers at St. Jude Children’s Research Hospital.

February 2020—Quest Diagnostics has acquired certain assets of the clinical laboratory services business of Boston Clinical Laboratories, based in Waltham, Mass.

February 2020—Foundation Medicine has received FDA approval for its FoundationOne CDx to be used as a companion diagnostic for Piqray (alpelisib) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor–positive, human epidermal growth factor receptor 2–negative, PIK3CA-mutated advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.

February 2020—Roche announced FDA approval of Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane [paclitaxel protein-bound; nab-paclitaxel] and carboplatin) for the initial treatment of adults with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations. The European Commission approved the combination therapy in September.

February 2020—The FDA granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2–based regimens in the metastatic setting. Enhertu is a human epidermal growth factor receptor 2–directed antibody and topoisomerase inhibitor conjugate.

February 2020—Siemens Healthineers announced the availability of its Enhanced Liver Fibrosis testing service in the United States, excluding New York State, and Puerto Rico. The testing service is provided by the Siemens Healthcare Laboratory.

January 2020—Olympus introduced its Slideview VS200 slide scanner, designed to capture high-resolution images for quantitative analysis for brain, cancer, and stem cell research, as well as drug discovery. The scanner uses Olympus X Line objectives, which are designed to deliver flatter images with a wide field of view and no intensity fall off at the periphery, improve numerical aperture, and offer a wider range of chromatic correction.

January 2020—Personal Genome Diagnostics received the CE mark for the PGDx Elio Tissue Complete assay. The panel is a 507-gene test for somatic alterations that detects single nucleotide variants, small indels, amplifications, rearrangements, microsatellite instability, and tumor mutation burden.

January 2020—ALPCO announced that the FDA granted its Calprotectin Chemiluminescence ELISA 510(k) clearance. It is intended for in vitro diagnostic use as an aid in the diagnosis of inflammatory bowel disease, specifically Crohn’s disease and ulcerative colitis, and as an aid in the differentiation of IBD from irritable bowel syndrome, in conjunction with other clinical and laboratory findings.

January 2020—Genentech announced positive data from the phase three IMpower110 study evaluating Tecentriq (atezolizumab) as a first-line monotherapy compared with cisplatin or carboplatin and pemetrexed or gemcitabine in advanced nonsquamous and squamous non-small cell lung cancer without ALK or EGFR mutations.

January 2020—Qiagen announced a series of agreements that expand its immuno-oncology assets for future commercialization of novel companion diagnostics, in particular based on next-generation sequencing technology. The agreements include a collaboration with Tokyo-based Repertoire Genesis that will provide access to novel technologies for the development of T-cell/B-cell receptor repertoire assays for use on NGS systems.

January 2020—Biodesix announced it has been issued a patent for its Biodesix Collection Device. The device aims to improve ease of use in blood sample collection for diagnostic testing. The BCD, which is currently used with the Biodesix Nodify XL2 test, combines multiple sample processing steps, including specimen collection and reproducible sample separation with ambient shipping. The company plans to use the BCD in all proteomic testing and make the device available for purchase by labs and diagnostic companies for sample processing and testing.

January 2020—Fujirebio Diagnostics received FDA clearance for its Lumipulse G whole PTH assay for testing on the Lumipulse G1200 immunoassay platform. The assay can be used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from calcium metabolism disorders. The fully automated assay has a reaction time of 30 minutes and uses a single test cartridge. It has demonstrated excellent precision with a coefficient of variation of ≤4.0 percent, the company reports.

January 2020—DiaSorin Molecular has released a primer pair that targets Candida auris, for use in laboratory-developed molecular tests. Candida auris is often multidrug resistant and has caused recent outbreaks in hospitals and long-term care facilities across the U.S. and in more than 20 countries, the company reports. The primer pairs are classified as analyte-specific reagents, which can be used by ...

January 2020—LGC Maine Standards released its Validate LP2 linearity and calibration verification kits for Roche Cobas analyzers. The kits evaluate apolipoprotein A (Apo-A1) and apolipoprotein B (Apo-B). Validate SP1 linearity and calibration verification kits, specifically targeted for Roche Cobas and Roche Cobas Integra analyzers, were also released. The kits evaluate α1-antitrypsin, complement C3, complement C4, immunoglobulin A, immunoglobulin G, immunoglobulin M, and transferrin. The Validate LP2 and SP1 kits are in a human serum matrix.

January 2020—Qiagen’s QuantiFeron-TB Gold Plus has been added to the diagnostic catalog of the Stop TB Partnership’s Global Drug Facility. The GDF provides quality-assured tuberculosis medicines, diagnostics, and laboratory supplies to the public sector.

January 2020—The FDA approved Descovy (emtrici­tabine 200 mg and tenofovir alafenamide 25 mg) in at-risk adults and adolescents weighing at least 35 kg (approximately 77 lbs.) for HIV-1 pre-exposure prophylaxis to reduce the risk of HIV-1 infection from sex, excluding those who have receptive vaginal sex. (Descovy is not indicated in individuals at risk of HIV-1 infection from receptive vaginal sex, the company reports, because the effectiveness in this population has not been evaluated.)

January 2020—ChromaCode has launched the HDPCR Multi-Drug Resistance (MDR) Panel, a highly multiplexed real-time PCR assay. The panel detects nine of the most common causes of Gram-negative multidrug resistance and toxigenic Clostridium difficile in a 96-well format. Key features of the panel, the company reports, include seamless integration onto common qPCR instrumentation, scalable throughput, and streamlined data analysis, management, and test customization with ChromaCode Cloud software. The MDR panel is for research use only.

January 2020—The FDA has approved Myriad Genetics’ MyChoice CDx for use as a companion diagnostic to identify women with advanced ovarian cancer who are candidates for Zejula (niraparib) in the late-line treatment setting. The FDA also approved the expanded use of Zejula (GlaxoSmithKline) for the treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer patients who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency.

January 2020—Oxford Gene Technology has developed the CytoSure NGS panel for the detection of loss of heterozygosity, mosaicism, copy number variants, single nucleotide variants, and indels. The solution features up-to-date content for intellectual disability and developmental delay, the targeted NGS panel, and Interpret software.

January 2020—Veracyte and NanoString have entered into an agreement in which Veracyte has obtained exclusive worldwide rights to develop and commercialize diagnostic tests on NanoString’s nCounter Flex system.

January 2020—Microbiologics has launched rifampicin-resistant Mycobacterium tuberculosis positive and negative control panels for quality control of MTB-RIF molecular assays and test methods. Features of the controls include separate positive and negative control products, positive control representing five common mutations to the rpoB gene associated with rifampicin resistance (L511P, H526Y, S531L, D516V, S522L), room-temperature storage, and inactivated microorganism pellets for in vitro diagnostic use.

January 2020—The FDA authorized marketing of Perkin­Elmer’s GSP Neonatal Creatine Kinase-MM kit, the first test to aid in newborn screening for Duchenne muscular dystrophy.

January 2020—Beckman Coulter Life Sciences announced its acquisition of Cytobank, a privately held, single-cell data analysis, software-as-a-service company based in Santa Clara, Calif.

December 2019—Quansys Biosciences (Logan, Utah) announced that its Q-Plex technology has been selected as a featured innovation at the Geneva Health Forum in Switzerland, March 24–26, 2020.

December 2019—DiaSorin Molecular received the CE mark for its Simplexa VZV Swab Direct assay. The molecular diagnostic test enables the direct detection of varicella-zoster virus DNA from cutaneous and mucocutaneous swab specimens.

December 2019—Menarini Silicon Biosystems launched MSBiosuite, a cloud-based solution that automates next-generation-sequencing data analysis for liquid biopsy and formalin-fixed, paraffin-embedded workflows. The solution, developed in partnership with BlueBee, provides NGS data processing, analysis, interpretation, and reporting for users of Menarini NGS library preparation kits. A clinical interpretation report is available optionally with the Ampli1 and DEPArray OncoSeek pipelines.

December 2019—On Oct. 1, CellaVision completed the acquisition of RAL Diagnostics (Martillac, France). RAL develops and sells products for sample preparation in hematology, microbiology, cytology, and pathology.

December 2019—Nova Biomedical announced the release of its Stat Profile Prime ES Comp Plus. The analyzer offers a complete electrolyte profile, including ionized magnesium, and optional serial batch testing on whole blood, serum, or plasma.

December 2019—nRichDX introduced its Revolution System, a high-yield sample prep platform designed to increase liquid biopsy–based test sensitivity by delivering more target input for molecular assays. The target yield increase is accomplished by combining the ability to process a range of sample volumes (3–50 mL) with recovery rates of 70–90 percent.

December 2019—Qiagen announced the publication of a multicenter clinical study demonstrating the accuracy of its QIAstat-Dx syndromic testing solution for diagnosing the causes of acute gastroenteritis. The study evaluated 385 patient samples at university hospital laboratories across Europe and showed the QIAstat-Dx Gastrointestinal Panel was highly sensitive (98.2 percent positive) and specific (99.9 percent negative). Multiple pathogens were identified in nearly one-third of the patient samples that tested positive. The study also cited the ability of the panel to provide cycle threshold values and amplification curves to aid in interpreting results.

December 2019—NeuMoDx Molecular announced an agreement with Amsterdam-based biotech company Self-screen BV to implement a CE-IVD-marked molecular diagnostic test for high-risk strains of human papillomavirus on the NeuMoDx 288 and NeuMoDx 96 molecular systems.

December 2019—Lucid Diagnostics received FDA 510(k) clearance for its EsoCheck Cell Collection Device. EsoCheck is a sterile, single-use disposable non-endoscopic balloon capsule catheter designed to collect and retrieve surface cells of the esophagus. The device is indicated for use in the general population of adults 22 years and older.

December 2019—Abbott announced that its Architect Stat High Sensitivity Troponin-I blood test has received clearance from the FDA for use on the Architect analyzer.

December 2019—Beckman Coulter announced that its DxA 5000 total laboratory automation solution has received FDA 510(k) clearance and is available for sale in the United States.

December 2019—Myriad Genetics announced the publication of results from a clinical outcomes study that demonstrated the Prolaris genetic test can identify men with low-risk prostate cancer who can safely select active surveillance and defer treatment.

December 2019—The Randox RX series provides laboratories with the capabilities of onboard HbA1c testing in whole blood on three fully automated RX analyzers—RX Modena, RX Imola, and RX Daytona+ —to accommodate rapid and reliable measurement of HbA1c in different laboratory settings.

December 2019—T2 Biosystems announced that its T2Resistance Panel is available as a research use only test in the United States. The panel is expected to receive the CE mark by the end of 2019.

December 2019—Ortho Clinical Diagnostics, in collaboration with Thermo Fisher Scientific, has expanded the menu on MicroTip-capable Vitros systems to enable testing for fentanyl and tricyclic antidepressants.

December 2019—MilliporeSigma has acquired FloDesign Sonics, Wilbraham, Mass., developer of an acoustic cell processing platform for cell and gene therapy manufacturing.

December 2019—Hematogenix announced the availability of the assessment of B-cell maturation antigen by flow cytometry and immunohistochemistry at its facilities in China, Asia, Europe, and the United States.

December 2019—The FDA granted breakthrough therapy designation to Novartis’ capmatinib (INC280) as a first-line treatment for patients with metastatic MET exon14 skipping-mutated non-small cell lung cancer.

December 2019—The Food and Drug Administration granted accelerated approval to the combination of pembrolizumab (Keytruda, Merck) plus lenvatinib (Lenvima, Eisai) for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high or mismatch repair deficient and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation.

December 2019—Roche announced the commercial availability of the Cobas EBV (Epstein-Barr virus) and Cobas BKV (BK virus) tests for use on the Cobas 6800/8800 systems in countries accepting the CE mark. The tests are used to assess if transplant patients are at risk of developing disease by these pathogens, which can contribute to organ rejection.

December 2019—The FDA approved Agilent Technologies’ PD-L1 IHC 22C3 pharmDx assay as an aid in identifying patients with esophageal squamous cell carcinoma for treatment with Keytruda (pembrolizumab), an anti-PD-1 therapy manufactured by Merck. Keytruda is approved for patients with recurrent locally advanced or metastatic ESCC whose tumors express PD-L1 (combined positive score ³10), as determined by an FDA-approved test, with disease progression on or after one prior line of systemic therapy.

December 2019—Roche announced that the European Commission has approved and granted marketing authorization for Tecentriq (atezolizumab) in combination with chemotherapy (carboplatin and Abraxane [albumin-bound paclitaxel]) for the initial treatment of adults with metastatic non-squamous non-small cell lung cancer who do not have EGFR mutant or ALK-positive NSCLC.

December 2019—Luminex Corp. has received FDA 510(k) clearance for the Aries MRSA Assay.

December 2019—Sysmex America and LabCorp announced an extension of their hematology automation agreement, to provide LabCorp Diagnostics’ primary reference laboratories with Sysmex America’s latest, upgraded XN-Series technology; the XN-9100 is a scalable, modular automation system that incorporates sample sorting robotics from Yaskawa Motoman.  

November 2019—ProciseDx received the CE mark for its Pro-ciseDx point-of-care diagnostic platform. The company will develop and commercialize near-patient, two- to five-minute tests to precisely quantify diagnostic and treatment
 monitoring markers for inflammatory and autoimmune diseases, such as celiac, and metabolic syndromes, including diabetes and prediabetes.

November 2019—Qiagen launched its QIAseq Expanded Carrier Screening Panel, which provides identification of targets, genes, and other regions of interest responsible for more than 200 disease indications. The QIAseq panel is integrated with the company’s CLC Genomics Workbench and Clinical Insight (QCI)-Interpret for QIAseq to provide evidence-based, actionable insights.

November 2019—Thermo Scientific’s Sensititre Gram Negative MDRGN1F AST Plate is now available on the Sensititre AST System. This format offers eravacycline, omadacycline, and plazomicin on an FDA-cleared, IVD-labeled microbroth dilution susceptibility plate for antimicrobial susceptibility testing using second-line multidrug-resistant organism therapies with expanded dilution ranges for Gram-negative organisms.

November 2019—Alcor Scientific introduced the miniiSED, the newest addition to its iSED family of erythrocyte sedimentation rate analyzers.

November 2019—ChromaCode announced publication of a study by the Medical College of Wisconsin, Milwaukee, and Gundersen Medical Foundation, La Crosse, Wis., highlighting the performance and utility of the High-Definition PCR Tick-Borne Pathogen Panel RUO.

November 2019—The U.S. Food and Drug Administration cleared for marketing four previously cleared tests with new indications to aid in the diagnosis of Lyme disease. The tests cleared involve a new testing paradigm in which two enzyme immunoassays are run concurrently or sequentially, rather than the current two-step process in which a Western blot must be run after the initial EIA test.

November 2019—A study conducted by Medical Database (Leblow L, et al. J Clin Lab Med. Sept. 5, 2019. doi:10.16966/2572-9578.128) showed that its laboratory decision system, LDS, reduced unnecessary test ordering.

November 2019—AutoGen has introduced its fully automated Xtract 16+, for nucleic acid purification from molecular diagnostic, biological, clinical, and forensic sample types. The Xtract 16+ offers nucleic acid isolation from liquid biopsies, plasma, serum, and other body fluids and can process up to 16 samples simultaneously.

November 2019—Hamilton Company introduced its compact Microlab Prep automated liquid handler, designed to fit on a lab bench or in a biological safety cabinet. The system consists of two independent pipetting channels and a high-speed multiprobe head as well as a configuration containing both pipetting technology types.

November 2019—Memorial Sloan Kettering Cancer Center announced that the New York State Department of Health has issued an approval for its Analysis of Circulating cfDNA to Evaluate Somatic Status (MSK-ACCESS) molecular assay. MSK-ACCESS was developed in the Marie-Josée and Henry R. Kravis Center for Molecular Oncology and has been clinically validated and implemented by members of MSK’s molecular diagnostics service.

November 2019—Binding Site’s Immunologicals Group has expanded its line of antibodies and antigens for human coagulation testing applications. Prothrombin and glycerol-free prothrombin proteins are available as antigens, and antibody products include anti-human factor H, factor I, fibrinogen, fibronectin, plasminogen, prothrombin, thrombin, and von Willebrand factor.

November 2019—Randox introduced a research use only sPLA2-IIA assay for use on a range of clinical chemistry analyzers. The latex-enhanced immunoturbidimetric assay measures sPLA2-IIA mass levels.

Biocare Medical released a mouse monoclonal antibody, p16 INK4a, for in vitro diagnostic use in the qualitative identification of the p16 INK4a protein by immunohistochemistry in formalin-fixed, paraffin-embedded human tissues.

November 2019—Bio SB has introduced its TintoDetector Mini Immuno staining system for immunohistochemical, immunocytochemistry, and immunofluorescence protocols in a semiautomated, open platform.

November 2019—The Centers for Medicare and Medicaid Services granted approval for a new technology add-on payment (NTAP) to T2 Biosystems’ T2Bacteria Panel, for fiscal year 2020. The T2Bacteria Panel is the first in vitro diagnostic test to receive approval for NTAP, according to the company.

November 2019—MicroMedicine introduced Sorterra, an automated, microfluidics-based cell isolation and concentration system for research and development and clinical research labs. Sorterra isolates white blood cells from 3 to 75 mL of anticoagulated peripheral blood at a rate of 150 mL per hour.

November 2019—The FDA granted in October marketing authorization of the OraQuick Ebola Rapid Antigen Test to OraSure Technologies. The test is intended for use in patients suspected of and with signs or symptoms consistent with Ebola virus disease and when the patient meets the CDC’s Ebola virus epidemiological criteria, such as history of residence in or travel to a geographic region with active EVD transmission at the time of travel.

November 2019—Sysmex Corporation has obtained Japanese manufacturing and marketing approval for the OncoBeam RAS CRC Kit, used for blood-based circulating tumor DNA molecular testing of mutations in the RAS gene for advanced colorectal cancer patients.

November 2019—Agilent Technologies introduced its xCELLigence RTCA eSight multimode real-time cell analyzer. The research use only system provides label-free, real-time biosensor measurements and kinetic imaging of the same live cell populations independently or simultaneously.

November 2019—The FDA has cleared iCubate’s iC-GN Assay for the detection and identification of Gram-negative bacteria that are associated with bloodstream infection and subsequent sepsis.

October 2019—The Project Santa Fe Foundation, which developed the concept of Clinical Lab 2.0, announced that it has filed for nonprofit 501c status and expanded its board of directors. New members of the board include health care leaders from Seattle Children’s Hospital, Intermountain Healthcare, University of Vermont, Mayo Clinic, and NorthShore University HealthSystem. “It is by design that PSFF did not trademark Clinical Lab 2.0, as we strongly believe that Clinical Lab 2.0 belongs to the health care industry, not to a single entity, and fundamentally believe that Clinical Lab 2.0 has no borders,” Khosrow Shotorbani, MBA, MT(ASCP), president and executive director of the Project Santa Fe Foundation, said in a press release. “The transition to value-based, Clinical Lab 2.0 standards will require cross-industry collaboration. We are honored to have these highly respected industry leaders join the global movement.” Project Santa Fe is a nonprofit organization founded through a collaboration of the Henry Ford Health System, Northwell Health, Geisinger Health System, and TriCore Reference Laboratories.

October 2019—The Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma. Pembrolizumab was approved for use in combination with platinum and fluorouracil for all patients and as a single agent for patients whose tumors express PD‑L1 (combined positive score, ≥1) as determined by an FDA‑approved test.

October 2019—ARUP Laboratories and Techcyte, a developer of artificial intelligence–based image analysis solutions for the diagnostics industry, have developed an AI-augmented ova and parasite detection tool.

October 2019—Biodesix (Boulder, Colo.) announced that it will acquire Oncimmune’s U.S. operations, which include a CLIA lab in De Soto, Kan., and the company’s incidental pulmonary nodule malignancy test, Early-CDT Lung.  

October 2019—Randox Laboratories announced that the NGSP has awarded it with a manufacturer certification for direct HbA1c testing on three of the company’s clinical chemistry analyzers, the RX Modena, RX Imola, and RX Daytona+.

October 2019—Myriad Genetics announced publication of results from a study that demonstrated the Prolaris test can accurately predict the 10-year risk of metastases in men newly diagnosed with localized prostate cancer (Canter DJ, et al. Prostate Cancer Prostatic Dis. Epub ahead of print June 27, 2019). The pooled analysis included 1,062 men with localized prostate cancer who were definitively treated ...

October 2019—The U.S. Federal Bureau of Investigation has approved Thermo Fisher Scientific’s Applied Biosystems Precision ID System mtDNA analysis solution for use by forensic laboratories to generate mitochondrial DNA profiles for submission to the U.S. National DNA Index System CODIS database.

October 2019—Menarini Silicon Biosystems launched its VRNxT, a sample preparation instrument that automates volume reduction steps in rare cell analysis workflows.

October 2019—Helmer Scientific launched its upright laboratory, pharmacy, and blood bank GX Solutions refrigerators, with models ranging from 13 to 56 cubic feet. GX Solutions are designed to keep temperatures within ±1°C throughout the unit, recover quickly from temperature changes after prolonged door openings, and maintain temperature stability.

October 2019—Bio-Rad Laboratories received FDA 510(k) clearance for its IH-500, an automated random access system for blood typing and screening, designed for small to medium-size laboratories. The system can process Bio-Rad’s range of IH gel cards for ABO blood grouping, reverse testing, phenotyping, Rh subgroups, antibody screening, antibody identification, single antigen testing, direct AHG testing, and crossmatching. In a separate ...

October 2019—The FDA approved Victoza (liraglutide) injection for treatment of pediatric patients 10 years or older with type 2 diabetes. Victoza is the first noninsulin drug approved to treat type 2 diabetes in pediatric patients since metformin was approved for pediatric use in 2000. Victoza has been approved to treat adult patients with type 2 diabetes since 2010.

September 2019—Clever Culture Systems announced FDA 510(k) clearance of its APAS Independence instrument and associated urine analysis module as a class II medical device. The APAS Independence automatically screens, interprets, and sorts culture plates and can process more than 200 culture plates at a time. The instrument sorts culture plates showing significant bacterial growth from those that do not, without the need for further microbiologist assistance, the company says.

September 2019—Mesa Biotech launched its respiratory syncytial virus test, the company’s second point-of-care test on its polymerase chain reaction testing platform, the Accula System, at the AACC annual scientific meeting. The Accula Flu A/Flu B test received FDA clearance in 2018. Both tests are indicated for use with nasal swab collection.

September 2019—The U.S. Food and Drug Administration permitted marketing of the Synovasure Lateral Flow Test Kit (CD Diagnostics) as an aid for the detection of periprosthetic joint infection in the synovial fluid of patients being evaluated for revision surgery. The test kit detects human alpha defensins in the synovial fluid of patients with a total joint replacement in approximately 10 minutes. The test is not intended to identify a specific type of infection.

September 2019—Caris Life Sciences has entered into a strategic collaboration with Debiopharm for the development of a companion diagnostic test using Caris’ whole transcriptome sequencing assay for mRNA analysis called MI Transcriptome. The assay, which was granted breakthrough device designation by the FDA in May, detects rare fibroblast growth factor receptor (FGFR1, FGFR2, and FGFR3) fusion events.

September 2019—Streck introduced three antibiotic resistance detection kits and its blood collection tube at the AACC Annual Scientific Meeting and Clinical Lab Expo, Aug. 6-–8, in Anaheim, Calif.

September 2019—Meridian Bioscience has acquired Quebec City-–based GenePOC, a provider of molecular diagnostic instruments and assays.

September 2019—Thermo Fisher Scientific previewed its Sensititre Aris HiQ AST System at the 71st annual AACC meeting. The benchtop automated reading and incubation system for antimicrobial susceptibility testing uses broth microdilution to provide minimum inhibitory concentration results.

September 2019—Quest Diagnostics announced the availability of its test panel to guide therapy with HIV pre-exposure prophylaxis, or PrEP. PrEP is the use of antiretroviral drugs to help prevent HIV infection in high-risk individuals who are not infected.

September 2019—Randox launched at the AACC annual meeting the Randox Stroke Biochip, a highly sensitive blood test that complements CT scanning technology to facilitate accurate classification of stroke patients. The test differentiates between ischemic and hemorrhagic stroke, directs the appropriate patient care pathway, and enables rapid thrombolytic therapy.

September 2019—Veravas launched three biotin interference products, VeraTest Biotin, VeraPrep Biotin, and VeraBind Biotin, for research use only.

September 2019—Ortho Clinical Diagnostics announced that its Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator (Vitros HIV Combo test) has been granted FDA premarket approval for use on Ortho’s Vitros XT 7600 Integrated System. The Vitros HIV Combo is a fourth-generation test that detects HIV-1 and HIV-2 antibodies and the p24 antigen.

September 2019—MedTest Dx introduced at the 2019 American Association for Clinical Chemistry annual scientific meeting an improved line of Clinitox Calibrators and Controls for confirmation testing. The product line aims to provide laboratories performing drugs of abuse testing a comprehensive and reliable calibration and controls solution with extended shelf life and simplified documentation.

August 2019—The U.S. Food and Drug Administration authorized marketing of a diagnostic test to detect Zika virus immunoglobulin antibodies in human blood. The ZIKV Detect 2.0 IgM Capture ELISA (InBios, Seattle) is the first Zika diagnostic test the FDA has allowed to be marketed in the U.S.; previously, tests for detecting Zika virus IgM antibodies, including the InBios test, had been authorized only for emergency use.

August 2019—NeuMoDx Molecular launched its CE-IVD assays for hepatitis B virus and hepatitis C virus. The company also launched CE-IVD assays for cytomegalovirus and Epstein-Barr virus.

August 2019—Binding Site’s Immunologicals Group added two native tick-borne encephalitis viral antigens to its line of products for in vitro diagnostic manufacturing and research applications. The standard version of the antigen as well as the premium version are for use as components in enzyme immunoassay testing procedures.

August 2019—The FDA approved lenalidomide (Revlimid, Celgene Corp.) in combination with a rituximab product for previously treated follicular lymphoma and previously treated marginal zone lymphoma.

August 2019—Genentech announced that the FDA has granted accelerated approval to Polivy (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan (rituximab) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma who have received at least two prior therapies. Accelerated approval was granted based on complete response rates observed in the phase one-b/two GO29365 study, a randomized, controlled clinical trial.

August 2019—Inova Diagnostics announced FDA 510(k) clearance of its Quanta Flash RF IgM and Quanta Flash RF IgA assays. The chemiluminescent immunoassays are used in human sera and are indicated for the quantitative determination of IgM rheumatoid factor antibodies (Quanta Flash RF IgM) and the semiquantitative determination of IgA rheumatoid factor antibodies (Quanta Flash RF IgA). The presence

August 2019—LGC Maine Standards released its Validate SP3 linearity and calibration verification kit for Roche Cobas and Beckman Coulter Immage analyzers. The kit, in a human serum matrix, evaluates α1-acid glycoprotein, antistreptolysin O, B2-microglobulin, and immunoglobulin E.

August 2019—Qiagen and Inovio Pharmaceuticals will collaborate to co-develop a companion diagnostic to guide clinical decision-making for the use of Inovio’s DNA-based immunotherapy to treat cervical dysplasia caused by human papillomavirus. The partnership focuses on Inovio’s VGX-3100

August 2019—Loop Genomics has expanded its kits and services capabilities to provide researchers with ultra-high resolution microbiome sequencing solutions using long reads on Illumina sequencers. The four kits are a low biomass (e.g. human skin) phased V1–V9 full-length 16S kit with picogram input amounts and zero human DNA background, a phased 18S-ITS1-ITS2 long-read solution for ultra-high

August 2019—Hamilton Company and Enable Biosciences announced a collaboration to provide fully automated processing of up to 96 liquid biopsy samples at one time using a novel ultra-sensitive and highly specific immunoassay in a hands-free workflow. The immunoassay, available for research applications in type 1 diabetes, Lyme disease, allergy, and HIV testing, is intended to support development of early-stage treatment interventions to improve patient health and quality of life with reduced disease-related complications.

August 2019—MDxHealth announced that a second clinical validation study demonstrating the performance of its liquid biopsy test SelectMDx for prostate cancer has been published in the Journal of Urology (Haese A, et al. 2019;202[2]:256–263).

August 2019—Thermo Fisher introduced its Invitrogen Collibri DNA Library Prep Kits for high-throughput Illumina systems. The kits contain a tracking dye to provide an in-process visual cue, which aims to improve workflow success.

August 2019—Motic Digital Pathology released the latest version of the FS-Live Telepathology Suite for remote pathology consultation and diagnosis. The updated software upgrades FS-Live to load up to six slides at a time, for individual live viewing and remote control.

August 2019—The Clinical and Laboratory Standards Institute has published the second edition of “GP33: Accuracy in Patient and Specimen Identification.”

August 2019—Myriad Genetics announced that its BRACAnalysis CDx companion diagnostic test effectively identified patients with metastatic pancreatic cancer who benefitted from treatment with olaparib (Lynparza, AstraZeneca) in the phase three POLO study. Results of the study were presented at the 2019 American Society of Clinical Oncology annual meeting in Chicago.

August 2019—SpeeDx Pty. announced that the FDA has granted breakthrough device designation for its ResistancePlus GC, a molecular test providing ciprofloxacin susceptibility and resistance information to effectively treat N. gonorrhoeae. It is CE marked and cleared by the Therapeutic Goods Association for use in Europe, Australia, and New Zealand.

August 2019—Oxford Gene Technology has expanded its SureSeq portfolio with the SureSeq NGS Library Preparation Kit, a library preparation solution for hybridization-based target capture in next-generation sequencing. The kit includes a ready-to-use hybridization and wash buffer. OGT has also developed a library preparation automation workflow available for the Agilent Bravo NGS (Option A) instrument that aims to further reduce manual handling and save time.

August 2019—Bühlmann Laboratories received FDA 510(k) clearance for its Bühlmann fCAL turbo in vitro diagnostic assay intended for the quantitative measurement of fecal calprotectin in human stool.

August 2019—BD announced the EU launch of its CE-IVD-marked BD COR, an automated, high-throughput molecular diagnostics system developed for large-capacity laboratories.

July 2019—Randox announced FDA 510(k) clearance for its RX Daytona+ clinical chemistry analyzer. The RX Daytona+ test menu includes routine chemistries, specific proteins, lipids, therapeutic drugs, drugs of abuse, antioxidants, and diabetes and is capable of performing emergency stat sampling. The fully automated benchtop analyzer has a combined throughput of 450 tests per hour, including ISE.

July 2019—Genentech announced results from the pivotal phase three CLL14 study in previously untreated chronic lymphocytic leukemia showing that Venclexta (venetoclax) plus Gazyva (obinutuzumab) met its primary endpoint of investigator-assessed progression-free survival.

July 2019—Natera announced plans to commercialize a research-use-only service for whole exome sequencing of circulating tumor DNA using plasma samples from patients with cancer.

July 2019—Beckman Coulter announced that its DxA 5000 total laboratory automation solution has achieved the CE mark and China Food and Drug Administration approval. The DxA 5000 aims to deliver rapid and consistent turnaround time, provide a new level of comprehensive preanalytical sample quality detection, and reduce the number of manual processing steps.

July 2019—Roche is expanding its partnership with Bio-Techne by offering chromogenic detection kits for automated in situ hybridization tissue analysis.

July 2019—HemoSonics announced that its Quantra Hemostasis Analyzer platform and QPlus cartridge have been granted de novo marketing authorization by the FDA and are available for sale in the United States.

July 2019—Advanced Instruments launched its Web-based Advanced QC Peer Group program. The program allows laboratories to compare their osmometer serum and urine QC with their peers’ data on a real-time and monthly basis. Laboratories can troubleshoot issues by providing instant and monthly reports to evaluate internal and external performance in real time. The program also aims to give labs increased assurance in proficiency survey and patient results.

July 2019—Prelude Corp. presented interim results from its Predict study during a poster presentation at the American Society of Breast Surgeons annual meeting, April 30–May 5, in Dallas (Abstract 581643).

July 2019—Siemens Healthineers announced the worldwide availability of its Atellica CH Enzymatic Hemoglobin A1c (A1c_E) Assay to assist clinicians in diagnosing and monitoring diabetes.

July 2019—Anpac Bio-Medical Science Company announced that its subsidiary Anpac Technology USA achieved CLIA certification for its San Jose, Calif.-based laboratory.

July 2019—Myriad Genetics announced a study published in Breast Cancer Research and Treatment found that the EndoPredict test accurately predicts which women with ER-positive, HER2-negative breast cancer will benefit from adjuvant chemotherapy.

July 2019—LGC Maine Standards launched its Validate LP linearity and calibration verification kit for Siemens Healthineers Advia and Atellica analyzers.

July 2019—Magnolia Medical Technologies and the Center for Phlebotomy Education have expanded their training and education partnership with a Web-based continuing education course now available with Professional Acknowledgment for Continuing Education (PACE) credits.

June 2019—Ortho Clinical Diagnostics’ Vitros XT MicroSlides have been cleared by the FDA. The product features multitest technology that allows laboratories to run two tests simultaneously on one MicroSlide.

June 2019—Positive data demonstrating the clinical value of ConfirmMDx and SelectMDx (MDxHealth, Irvine, Calif.) for prostate cancer were presented in two moderated posters at the American Urological Association annual meeting, May 1–6 in Chicago.

June 2019—BD announced the worldwide availability of its FDA-cleared and CE-marked BD Bactec platelet quality control media to identify contaminated platelet units. The product can be used for quality control testing of leukocyte-reduced apheresis platelet units: leukocyte-reduced single and a pool of up to six units of leukocyte-reduced whole blood platelet concentrates.

June 2019—The Food and Drug Administration approved pembrolizumab (Keytruda, Merck) plus axitinib for the first-line treatment of patients with advanced renal cell carcinoma. Approval was based on Keynote‑426, a randomized, multicenter, open-label trial conducted in 861 patients who had not received systemic therapy for advanced renal cell carcinoma. Patients were enrolled regardless of PD-L1 tumor expression status.

June 2019—GenePOC announced that its GenePOC Carba assay received CE marking. The assay is a qualitative, in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48-like, and blaIMP gene sequences associated with carbapenem nonsusceptibility.

June 2019—Indivumed and Flagship Biosciences have announced a partnership in which the companies will offer a comprehensive set of services combining Flagship’s experience in biomarker development and Indivumed’s multiplex immunohistochemistry assay development capabilities.

June 2019—Ambry Genetics announced a laboratory services agreement with Clovis Oncology.

June 2019—Banyan Biomarkers will provide Abbott a license for its traumatic brain injury blood biomarkers, ubiquitin carboxy-terminal hydrolase-L1 (UCH-L1) and glial fibrillary acidic protein (GFAP), for use on Abbott’s core laboratory instruments.

June 2019—T2 Biosystems (Lexington, Mass.) announced that a study demonstrating the advantages of its T2Bacteria Panel and how it can aid in diagnosing bloodstream infections was published in the Annals of Internal Medicine.

June 2019—Qiagen and NeuMoDx Molecular are expanding the menu for the NeuMoDx 96 and 288 molecular systems. The companies also announced the commercial availability of the NeuMoDx 96 mid-throughput version of the fully integrated PCR-based systems.

June 2019—PerkinElmer, in collaboration with Helix, launched a genetic screening test called GenePrism: Actionable Insights, which analyzes a subset of 59 medically actionable genes, including BRCA1 and BRCA2, identified by the American College of Medical Genetics and Genomics.

June 2019—GenMark Diagnostics received FDA 510(k) clearance for its ePlex Blood Culture Identification Gram-Negative Panel.

June 2019—Group K Diagnostics has signed an agreement with the Centers for Disease Control and Prevention to design and evaluate a prototype reverse transcriptase loop-mediated isothermal amplification assay for the detection of the Zika virus RNA that can be performed by clinical personnel or health care practitioners where real-time RT-PCR instrumentation is not available.

May 2019—BD announced CE-IVD certification for its BD FacsDuet automated flow cytometry system. The fully automated sample preparation instrument aims to reduce errors and limit the manual user interactions required to run assays on the BD FacsLyric clinical flow cytometer.

May 2019—Roche presented at the American Association for Cancer Research annual meeting the initial results from a phase one-b study evaluating the efficacy and safety for the combination of ipatasertib, Tecentriq (atezolizumab) and chemotherapy (paclitaxel or nab-paclitaxel (Abraxane [paclitaxel albumin-bound particles for injectable suspension]) as a first-line treatment option for people with advanced triple-negative breast cancer.

May 2019—Qiagen introduced its exoRNeasy Midi and Maxi kits for isolation of exosomes and other extracellular vesicles from urine and other samples and its miRNeasy 96 Advanced QIAcube HT Kit for automated purification of total RNA, including miRNA, from serum and plasma samples.

May 2019—Binding Site’s Immunologicals Group has added purified monoclonal antibodies for the testing of human immunodeficiency virus, designed for use as components within enzyme immunoassay test procedures.

May 2019—Schuyler House introduced its Turn Around Time (TAT) Monitor for its medical laboratory software SchuyLab.

May 2019—Genentech announced FDA approval of Tecentriq (atezolizumab) in combination with carboplatin and etoposide for the initial treatment of adults with extensive-stage small cell lung cancer.

May 2019—Cepheid announced the CE-IVD marking of Xpert HBV Viral Load, a rapid test for the quantitation of hepatitis B virus that delivers results in less than one hour.

May 2019—Thermo Fisher Scientific launched its standard performance ultra-low temperature freezer series.

May 2018—Sysmex America announced the availability of its first fully automated urine particle counter and digital imaging system, the UN-2000. The scalable system is composed of the UF-5000 automated urine particle analyzer and UD-10 automated urine particle digital imaging device.

May 2019—Sakura Finetek USA launched two ready-to-use antibodies in the United States and eight outside the U.S. for use on the Tissue-Tek Genie Advanced Staining System.

May 2019—Agilent Technologies announced its Magnis NGS Prep System, a fully automated next-generation sequencing library preparation system designed to run complex DNA sequencing assays.

May 2019—Nikon Instruments debuted the OS-15-N, a digital slide scanning system featuring Nikon optics, at the USCAP annual meeting, March 16–21, National Harbor, Md. Nikon partnered with OptraScan to provide an end-to-end digital pathology solution that takes advantage of Nikon’s optics and OptraScan’s desktop slide scanning system, the OS-15.

May 2019—Helmer Scientific has unveiled its GX Solutions, professional medical-grade refrigerators with OptiCool cooling systems. The refrigerators have been designed for the needs of critical health care applications, such as medication, vaccine, blood, and patient sample storage and offer control in temperature management, noise management, and energy management.

May 2019—Roche and Spark Therapeutics entered into a definitive merger agreement for Roche to fully acquire Spark Therapeutics for about $4.3 billion.

May 2019—The Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for the first-line treatment of patients with stage III non-small cell lung cancer who are not candidates for surgical resection or definitive chemoradiation or metastatic NSCLC.

May 2019—Bio SB announced its line of Fast Mohs IHC antibodies and detection systems for immunohistochemical cancer detection on frozen tissue after Mohs surgery.

April 2019—Luminex has completed its acquisition of MilliporeSigma’s flow cytometry portfolio for $75 million. The flow cytometry portfolio includes the Amnis family of imaging flow cytometry products for cell-based analysis and the Guava portfolio of microcapillary flow cytometry systems. “The Amnis and Guava products complement our wide range of existing flow-based offerings, further differentiating our portfolio and ensuring we are well positioned to support customers today and into the future,” Homi Shamir, president and CEO of Luminex, said in a press release. “With this acquisition, we now have expanded our installed base to include more than 5,000 flow cytometry systems worldwide, adding to our impressive footprint and creating the potential for additional meaningful growth.” The buyout is expected to contribute $40–$50 million in revenue to Luminex this year.

April 2019—Bio-Rad Laboratories announced the launch of Quantify Advance Control, an independent quality control used to monitor the precision of laboratory urinalysis test procedures. The control contains human urine solution and offers 31 days of open vial stability for all analytes, including ketones, at room temperature.

April 2019—Audit MicroControls announced several additions to its line of calibration verification/linearity and daily quality control products. The company’s galectin-3 linearity and control kits are for use with quantitative assays on clinical laboratory analyzers, simulating human patient samples.

April 2019—The Food and Drug Administration approved trastuzumab and hyaluronidase-oysk (Herceptin Hylecta, Genentech) for subcutaneous injection for the treatment of certain people with HER2-positive early breast cancer in combination with chemotherapy and HER2-positive metastatic breast cancer in combination with paclitaxel or alone in people who have received one or more chemotherapy regimens for metastatic disease.

April 2019—PMT Scientific, a company that designs morgue, pathology, histology, and vivarium medical equipment, is now operating in Redford, Mich. PMT Scientific focuses on providing custom grossing stations along with a complete array of pathology equipment. Its grossing stations incorporate height-adjustable actuators, high-color-rendering lighting, and durable and easy-to-maintain plumbing fixtures, and can come equipped with air quality monitoring devices.

April 2019—Worthington Biomedical Corp. has released the 18th edition of its Tissue Dissociation Guide for biochemistry, cell biology, molecular biology, preclinical research, and bioprocessing applications.

April 2019—The U.S. Food and Drug Administration is issuing a proposed order to exempt certain class II flow cytometry instruments from premarket notification (510[k]) requirements, subject to limitations and conditions.

April 2019—GenePOC announced its GenePOC Strep A assay has been cleared by the FDA for use with the Revogene device. The assay is a qualitative in vitro diagnostic test for the detection of Streptococcus pyogenes nucleic acids from throat swab specimens. It can provide results in 42 minutes for positive specimens and in about 70 minutes for negative specimens, without the need for culture confirmation.

April 2019—NeoGenomics announced availability of the Ventana PD-L1 (SP142) Assay for tumor tissue from patients with the triple negative subtype of breast cancer.

April 2019—Qiagen and Tecan Group announced a collaboration to improve the processing of Qiagen’s QuantiFeron-TB Gold Plus diagnostic test. The companies are working together to optimize a solution that standardizes and automates the manual steps in liquid handling for the aliquoting of samples.

April 2019—LGC Maine Standards has added Cerebrospinal Fluid Total Protein to its Validate Body Fluids kit for laboratory-developed test validation, documentation of linearity, calibration verification, and verification of the reportable range.

April 2019—Abbott announced that Regional Medical Laboratory, of Tulsa, Okla., will use Abbott’s Alinity ci-series. RML, part of the Ascension network, performs diagnostics testing for more than 2.4 million patients through hospital systems in Texas, Wisconsin, Oklahoma, Kansas, and Tennessee.

April 2019—Ortho Clinical Diagnostics, in collaboration with Beijing Leadman Biochemistry, launched four MicroTip partnership assays in China. The assays, for renal, liver, and cardiac testing, include cystatin C, α-hydroxybutyrate dehydrogenase, homocysteine, and total bile acid.

April 2019—Hardy Diagnostics is now an authorized distributor of EliTech’s Mycofast US, a rapid system to detect, enumerate, and identify genital Mycoplasma hominis and Ureaplasma urealyticum.

April 2019—Abbott announced it has received the CE mark for its Alinity m automated molecular diagnostics system and assays. Alinity m features ReadiFlex technology, the company’s proprietary technology for true random access, a universal sample rack, and a time to first result of less than 115 minutes. The system can provide 300 results in about eight hours and can have up to 20 assays onboard at one time.

April 2019—EKF Diagnostics has signed a private label distribution agreement with McKesson Medical-Surgical for the company’s hand-held, reagent-free hemoglobin analyzer, the DiaSpect. The DiaSpect will be sold by McKesson under its own branded line as the McKesson Consult Hb analyzer.

March 2019—Sarstedt has released its next generation of vacuum filtration products. Options include bottle top filters, receiver bottles, and assembled units available in 250 mL, 500 mL, and 1,000 mL. The filters contain wide, 90-mm diameter polyethersulfone membranes with 0.2 µm and 0.45 µm pore sizes; 500 mL filters are also available with a 0.1 µm pore size for mycoplasma removal. The bottle tops are one-piece construction to prevent leakage above the neck and reduce overall height.

March 2019—Fluidigm introduced its Maxpar Human Immune Monitoring Panel Kit for comprehensive immune cell profiling in cancer and immune-mediated diseases. The immune monitoring kit contains 29 metal-labeled antibodies and reagents designed for deep immune profiling of human peripheral blood mononuclear cells in one tube.

March 2019—Bio-Techne announced the launch of its cell and gene therapy portfolio.

March 2019—BD announced that its BD Phoenix CPO detect test to identify infections caused by carbapenemase-producing organisms has received 510(k) clearance by the Food and Drug Administration.

March 2019—Roche announced FDA approval of Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) and paclitaxel and carboplatin for the initial treatment of people with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.

March 2019—Nova Biomedical has been awarded a multiyear group purchasing agreement for critical care blood gas analyzers from Premier. The agreement allows Premier members to take advantage of special, prenegotiated pricing and terms for Nova’s Stat Profile Prime Plus critical care blood gas analyzers and consumables in addition to Nova’s 10-test Prime.

March 2019—Qiagen released a bioinformatics analysis tool designed to bring the company’s sequencing analysis solutions to biologists who do not have a primary focus on bioinformatics.

March 2019—BioMérieux’s BacT/Alert BPA and BPN culture bottles have received 510(k) clearance from the FDA. The culture bottles are for quality control testing of leukocyte-reduced apheresis platelet units and support the growth of aerobic and anaerobic microorganisms in two types of leukocyte-reduced units: apheresis platelet units and both single and pools of up to six units of whole blood platelet concentrates.

March 2019—BD announced FDA 510(k) clearance of its BD Max enteric viral panel, a molecular diagnostic test for the direct qualitative detection and differentiation of enteric viral pathogens that cause viral gastroenteritis.

March 2019—Binding Site’s Immunologicals Group has added five recombinant Epstein-Barr virus antigens to its line of products for in vitro diagnostic manufacturing and research applications. The EBV capsid antigen P18; EBV capsid antigen P23; EBV early antigen P138; EBV early antigen P54; and EBV nuclear antigen EBNA1, P72 have been designed for use as components within solid phase enzyme immunoassay test procedures, especially ELISA. The antigens are E. coli source-derived recombinant proteins.  

March 2019—Thermo Fisher’s ImmunoCAP Specific IgE blood test for Ara h 6, part of a line of assays for detecting specific peanut allergen components, has been cleared by the FDA for in vitro diagnostic use.

March 2019—CellaVision has launched its CellaVision DC-1, a digital system for blood cell analysis designed for small and mid-size clinical laboratories. The system is commercially available for the markets accepting the CE mark.

March 2019—Quidel has received the CE mark for its Sofia Quantitative Vitamin D FIA for use with the Sofia fluorescent immunoassay analyzer for the quantitative determination of total 25-OH vitamin D from serum samples. The test is intended for use with the Sofia analyzer to aid in the assessment of vitamin D sufficiency and is the first quantitative assay on the Sofia.

March 2019—EntroGen announced the availability of a lung cancer RNA panel intended for the qualitative detection of ALK, ROS1, and RET fusion genes, as well as MET exon 14 skipping mutations in human lung RNA.

March 2019—The FDA has approved ID Core XT, a molecular-based assay used in blood transfusion medicine to help determine blood compatibility. The assay can be used to determine blood donor and patient non-ABO red blood cell types. ID Core XT is the second molecular assay approved for use in transfusion medicine and the first to report genotypes as final results.  

March 2019—Hycor Biomedical received FDA 510(k) clearance for its new allergy testing system, Noveos. Features of the system include a reduction in sample size (4 μL of serum per test), reduced blood-based interferences, less variability within allergen lots, increased accuracy, and improved walkaway time, the company reports.

March 2019—The Japanese Pharmaceuticals and Medical Device Agency has approved Qiagen’s Therascreen EGFR RGQ PCR Kit for use as a companion diagnostic with Pfizer’s Vizimpro (dacomitinib) for EGFR gene mutation-positive, inoperable or recurrent non-small cell lung cancer.

March 2019—Bio-Rad Laboratories announced the availability of Liquichek Serum Indices, used as part of laboratory interference testing to monitor an instrument’s ability to detect hemolysis, icterus, and lipemia specimen interferences in patient samples.

February 2019—Qiagen launched the QIAcube Connect, the next generation of the QIAcube instrument. QIAcube Connect fully automates the lysis, bind, wash, and elute steps of the Qiagen spin columns (which can also be used manually) for DNA, RNA, and protein sample processing. It is compatible with a range of the company’s sample technologies and can be used to automate more than 80 Qiagen kits with more than 3,000 proven protocols.

February 2019—Siemens Healthineers and Healthy.io have announced a worldwide original equipment manufacturer alliance in which Siemens urinalysis reagents will integrate into Healthy.io’s smartphone-based urinalysis system to provide a home testing option to monitor kidney function.

February 2019—Roche announced that the FDA has approved Xofluza (baloxavir marboxil) for the treatment of acute, uncomplicated influenza in people 12 years of age and older. Xofluza is a single-dose oral medicine with a novel proposed mechanism of action that inhibits polymerase acidic endonuclease.

February 2019—National Jewish Health Advanced Diagnostic Laboratories has launched a line probe assay to detect nontuberculous mycobacteria infections and identify NTM species and drug-resistance markers at a molecular level within 48 hours after obtaining a sample from culture.

February 2019—Insight Genetics launched its proprietary Insight TNBCtype, a test for categorizing triple-negative breast cancer tumors into distinct molecular subtypes through its wholly owned CLIA- and CAP-accredited laboratory, Insight Molecular Labs.

February 2019—Leica Biosystems launched a programmed death-ligand 1 antibody. The PD-L1 1 (73-10) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of endogenous PD-L1 protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the company’s fully automated Bond system.

February 2019—The Lunar assay, a new blood-based assay intended to detect early-stage cancer and recurrence of disease, is available from Guardant Health for research use by biopharmaceutical and academic researchers.

February 2019—Thermo Fisher Scientific received FDA clearance for its de novo submission of its QMS Plazomicin Immunoassay. This quantitative immunoassay measures the concentration of a novel therapeutic antibiotic, plazomicin, using the Beckman Coulter AU 680 automated clinical chemistry analyzer. Plazomicin (Zemdri, Achaogen) is a next-generation aminoglycoside being used to treat patients with complicated urinary tract infections.

February 2019—The Food and Drug Administration approved gilteritinib (Xospata, Astellas Pharma) for treatment of adult patients who have relapsed or refractory acute myeloid leukemia with an FLT3 mutation as detected by an FDA-approved test.

February 2019—CellMax Life announced the kickoff of its Zenith study, a U.S. clinical study for the company’s circulating tumor cell blood test.

February 2019—Quest Diagnostics has signed a definitive agreement to acquire the assets of the clinical laboratory services business of Boyce and Bynum Pathology Laboratories; BBPL’s anatomic pathology division, long-term care division, and Boyce and Bynum Pathology Professional Services are not part of the transaction.

February 2019—The FDA granted accelerated approval to larotrectinib (Vitrakvi, Loxo Oncology) for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase gene fusion without a known acquired resistance mutation, are metastatic, or where surgical resection is likely to result in severe morbidity and have no satisfactory alternative treatments or that have progressed following treatment.

February 2019—Microbiologics launched two panels for quality control of group A Streptococcus and respiratory molecular assays and test methods. The Group A Streptococcus Control Panel and Respiratory (21 Targets) Control Panel feature multiplexed pellets and swabs that mimic patient sample processing and are stored at room temperature.

February 2019—Mesa Biotech has received 510(k) clearance and CLIA waiver from the FDA for its Accula RSV test, cleared for diagnosing children and adults.

February 2019—ChromaCode announced the commercial launch of its first multiplex test using the company’s proprietary high-definition polymerase chain reaction technology.

February 2019—Inova Diagnostics announced FDA clearance of its Fecal Extraction Device for use in conjunction with Quanta Flash Calprotectin, which aids in the diagnosis of inflammatory bowel disease and helps differentiate IBD from irritable bowel syndrome.

February 2019—DiaSorin Molecular announced the availability of three new primer pairs for atypical pneumonia that can be used in laboratory-developed tests. The specific targets are Legionella species, Chlamydophila pneumoniae, and Mycoplasma pneumoniae.

February 2019—The FDA granted accelerated approval to pembrolizumab (Keytruda, Merck) for patients with hepatocellular carcinoma who have been previously treated with sorafenib.

February 2019—Binding Site’s Immunologicals Group has added to its line of products purified proteins to be used for the analysis and testing of hepatitis.

February 2019—Streck Retic-Chex Linearity for BC is now assayed for the Beckman Coulter UniCel DxH 900 analyzer. Retic-Chex Linearity for BC is designed to establish the reportable range and linearity of analyzers that report the reticulocyte parameter.

February 2019—Dragonfly Therapeutics has entered into a new agreement with Celgene to discover, develop, and commercialize immunotherapies for patients with solid and hematological cancers.

February 2019—Quidel has received the CE mark for its TriageTrue High Sensitivity Troponin I Test for the quantitative determination of troponin I in EDTA anticoagulated whole blood and plasma specimens. The test is to be used as an aid in the diagnosis of myocardial infarction for use with the company’s Triage MeterPro instrument.

February 2019—Viracor Eurofins launched a 16S Next Generation Sequencing Bacterial Meningitis test for use in patients suspected of having bacterial meningitis.

February 2019—NxGen MDx introduced its NxGen MDx Hereditary Cancer Panel, which tests for variants in 32 genes known to cause certain forms of hereditary cancer.

February 2019—ArcherDx announced that the FDA granted a breakthrough device designation for its companion diagnostic assay application.

February 2019—The FDA granted accelerated approval to pembrolizumab (Keytruda, Merck) for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.

February 2019—London-based LGC announced the acquisition of SeraCare Life Sciences. SeraCare provides quality control materials for infectious disease testing through its Accurun reagents and next-generation sequencing reference materials through its Seraseq products for oncology, noninvasive prenatal testing, and inherited disease testing.

February 2019—Olaparib (Lynparza, AstraZeneca) has been approved by the FDA for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line, platinum-based chemotherapy.

January 2019—Menarini Silicon Biosystems announced the launch of its DEPArray FFPE Sample­Prep Kit at the Association for Molecular Pathology’s annual meeting. The kit allows for the disaggregation and staining of formalin-fixed, paraffin-embedded tissue sections down to a single-cell suspension. The kit enables the detection, identification, and recovery of different cell populations by the DEPArray system based on specific immunofluorescent staining and DNA content. It has been tested using FFPE human tissue sections of primary and metastatic keratin-positive carcinomas in lung, breast, colon, pancreas, prostate, and ovarian tissues.

January 2019—SeraCare Life Sciences announced an exclusive partnership with AccuRef Diagnostics, a division of Applied StemCell, to market and sell AccuRef’s portfolio of CRISPR-engineered cell line reference materials alongside the Seraseq portfolio of NGS cancer products.

January 2019—Qiagen launched its QIAscreen HPV PCR Test, a CE-marked in vitro molecular diagnostic test for the detection of 15 recognized high-risk genotypes of human papillomavirus. Validated sample types include cervical specimens collected in PreservCyt, Pathtezt, and Surepath collection medium, as well as self-collected vaginal brush specimens collected and shipped dry or in saline or self-collected cervico-vaginal lavage specimens.

January 2019—Quest Diagnostics and Oxford Immunotec announced that Quest has completed its acquisition of the U.S. laboratory services business of Oxford Immunotec; the T-Spot.TB tuberculosis and the Accutix tick-borne disease testing services are now part of Quest’s portfolio of infectious disease testing services.

January 2019—Ortho Clinical Diagnostics is offering three new assays through its MicroTip Partnership Assay program. The company will offer kappa free light chain and lambda free light chain assays in collaboration with Diazyme Laboratories and a methotrexate assay through a collaboration with Ark Diagnostics and Sekisui Diagnostics.

January 2019—The FDA expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma. This is the first FDA approval for the treatment of newly diagnosed PTCL.

January 2019—Leica Biosystems has partnered with Ultivue to co-market Ultivue’s Ulti­Mapper assays with Leica’s Bond Rx research staining platform.

January 2019—The FDA has accepted Roche’s supplemental biologics license application and granted priority review to the company’s Tecentriq in combination with Abraxane (nab-paclitaxel, Celgene) for the initial treatment of people with PD-L1-positive, metastatic triple-negative breast cancer.

January 2019—Bio-Rad has announced its InteliQ selection of quality controls, available in barcoded, load-and-go tubes. This new configuration is designed to help optimize workflow efficiency and improve the laboratory’s risk management program.

January 2019—Genomic Testing Cooperative announced it will offer multiple laboratory-developed genomic profiling tests for hematologic and solid tumors using next-generation sequencing technology.

January 2019—Hologic announced the availability of Open Access functionality for its Panther Fusion system. This enhanced functionality will allow CLIA-certified laboratories to develop laboratory-developed tests to run on the fully automated Fusion platform.

January 2019—Illumina announced it will acquire Pacific Biosciences for approximately $1.2 billion.

January 2019—The FDA approved Truxima (rituximab-abbs, Celltrion) as the first biosimilar to Rituxan (rituximab, Genentech) for patients with CD20-positive, B-cell non-Hodgkin lymphoma to be used as a single agent or in combination with chemotherapy.

January 2019—Ortho Clinical Diagnostics’ Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator received FDA approval for use on Ortho’s Vitros 5600 Integrated System.

December 2018—Beckman Coulter launched Kaluza C Flow Cytometry Analysis Software, which aims to streamline clinical QC reporting and address standardization issues in flow cytometry. Kaluza C improves the visualization and analysis of rare events. It makes it possible to process large, multicolor files with up to 20 million events and set the plot resolution according to the gate level. The software enables the operator to focus on a limited number of events to preserve the integrity of the scatterplot.

December 2018—Chembio Diagnostics announced FDA emergency use authorization for its DPP Ebola Antigen System for use with human capillary fingerstick whole blood, EDTA venous whole blood, and EDTA plasma. The test detects viral antigens and provides qualitative results in 15 to 20 minutes when used with the handheld, battery-operated DPP Micro Reader.

December 2018—Myriad Genetics announced FDA approval of its BRACAnalysis CDx to identify patients with HER2-negative metastatic breast cancer who have a germline BRCA mutation and are eligible for treatment with Pfizer’s PARP inhibitor, Talzena (talazoparib).

December 2018—BD announced the availability of the CE-marked BD Max MDR-TB panel in Europe. Clinicians can use the single PCR-based molecular diagnostic test to simultaneously detect bacteria that cause tuberculosis and determine if the bacteria contain mutations associated with resistance to two first-line drugs, isoniazid and rifampicin.

December 2018—Mawi DNA Technologies launched its iSwab-Cells cell stabilization product line. Designed to collect and stabilize intact cells for up to four weeks at room temperature, the sample collection system enables users to perform multiple omics analyses from the same sample.

December 2018—GenomOncology announced that Emory Healthcare is using GenomOncology’s GO Pathology Workbench system as part of its clinical reporting process.

December 2018—Sakura Finetek USA launched the Tissue-Tek Prisma H&E Stain Kit #1, specifically designed for the Tissue-Tek Prisma line of stainers.

December 2018—The FDA has granted 23andMe de novo authorization to offer direct-to-consumer reports on pharmacogenetics. The authorization allows 23andMe to report variants in multiple genes that are associated with how an individual may metabolize some medications.

December 2018—Sysmex Inostics announced publication of a study in the Journal of Molecular Oncology (Rowe SP, et al. 2018;12[10]:1661–1672) highlighting the clinical value of blood-based ctDNA mutation testing to complement standard-of-care management of patients with advanced melanoma.

December 2018—LGC Maine Standards has released its Validate Body Fluids kit, 205bf. The kit, in a simulated body fluid matrix, will assist in the documentation of linearity, calibration verification, and verification of the reportable range for albumin, amylase, cholesterol, creatinine, glucose, lactate, lactate dehydrogenase, total protein 2, triglycerides, and urea nitrogen.

December 2018—Ansh Labs has received de novo FDA clearance for its MenoCheck picoAMH ELISA.

December 2018—Qiagen announced the worldwide launch of the QIAamp PowerFecal Pro DNA Kit, for the extraction of high-quality DNA from fecal and gut samples.

December 2018—Agena Bioscience released its Chimeric ID Panel, designed to reduce the time and cost of performing chimerism analysis for bone marrow engraftment monitoring studies.

December 2018—Knowledge-Quest announced a new virtual textbook titled “Diagnostic Encyclopedia of Medicine,” or DxEM, a digital library for medical diagnosis available at dxconcur.com.

December 2018—LGC Maine Standards released its Validate CM2 linearity and calibration verification kit for Ortho Vitros analyzers.

December 2018—Australian health care company Primary Health Care has joined forces with Siemens Healthineers to deploy more than 70 Atellica Solution immunoassay and clinical chemistry analyzers.

December 2018—MDxHealth announced that the journal Urology Practice has published a study demonstrating the clinical utility of SelectMDx, a noninvasive liquid biopsy test to identify patients at increased risk of aggressive prostate cancer, in guiding initial prostate biopsy decision-making.

December 2018—A prospective study in patients with advanced non-small cell lung cancer has demonstrated that the blood-based Guardant360 assay, developed by Guardant Health, identified clinically actionable mutations in nearly twice as many patients as tissue biopsy alone.

December 2018—Magnolia Medical Technologies launched its new Best Practice Blood Culture Kit. The kit, developed in partnership with Aero-Med, includes the Steripath Gen2 Initial Specimen Diversion Device, two blood culture bottles, one ChloraSep antiseptic skin prep, and two alcohol prep pads.

December 2018—Qiagen launched its QIAseq FastSelect RNA Removal Kit, which allows rapid selective removal of RNA classes from any sample, enabling researchers to attain high-quality, reproducible RNA sequencing results.

December 2018—Precipio launched a new ICEme kit using the company’s proprietary Ice-Cold PCR technology. The kit provides physicians with the ability to use a liquid biopsy to identify patients eligible for tyrosine kinase inhibitor therapies through analysis of tumor DNA for these EGFR mutations.

November 2018—Qiagen has introduced an automated, CE-marked workflow for its Quanti-Feron-TB Gold Plus Blood Collection Tubes and a novel DiaSorin Liaison Test on DiaSorin’s Liaison systems. The launch offers Liaison customers high-throughput detection with QFT-Plus as part of the system’s broad menu, and QFT-Plus users will gain an option for full automation of laboratory handling to support TB control efforts. Customers using the new latent TB detection workflow for Liaison systems will purchase the detec-tion components from DiaSorin and the blood collection tube kits from Qiagen. The test is available in Europe and other markets, with an expected U.S. release in 2019 and in China in 2020. In a separate release, Qiagen and NeuMoDx Molecular announced a strategic partnership to commercialize two fully integrated systems for automation of PCR test-ing. Under the agreement, Qiagen will initially distribute the NeuMoDx 288 (for high throughput) and NeuMoDx 96 (for mid-throughput) in Europe and other markets outside of the United States; NeuMoDx will cover the U.S.

November 2018—Detroit-based Henry Ford Health System Pathology and Laboratory Medicine announced a research and development partnership with Sakura Finetek USA to increase the automation level of its core anatomic pathology laboratories.

November 2018—Beckman Coulter Diagnostics is collaborating with Johns Hopkins Medicine to explore co-innovation initiatives with the goal of developing and commercializing novel solutions that address challenges in health care.

November 2018—Qiagen and Hamilton Robotics announced a collaboration to improve processing of Qiagen’s QuantiFeron-TB Gold Plus diagnostic test through the integration of Hamilton’s Microlab Star automated liquid handling workstation into the QFT-Plus assay workflow.

November 2018—Singulex introduced its Singulex Clarity C. diff toxin A/B assay. The assay is a rapid, high-sensitivity, high-precision, one-step solution to C. difficile toxin testing that matches the sensitivity and specificity of cell cytotoxicity neutralization assay, the company reports, “giving it the potential to reduce the false-positives of PCR and the false-negatives of current, less sensitive toxin immunoassays.”

November 2018—Heathrow Scientific introduced its MagFuge high-speed centrifuge and magnetic stirrer in one unit. The MagFuge features a back-lit digital display and one button programming. Three rotors are included, two for centrifugation (a 12 place for 1.5/2.0 mL tubes and a six place for 5 mL tubes, with adapters for additional tube sizes) and one for stirring that includes two rare earth magnets for high-performance mixing.

November 2018—Roche announced the phase three KATHERINE study met its primary endpoint, showing Kadcyla (trastuzumab emtansine) as a single agent significantly reduced the risk of disease recurrence or death (invasive disease-free survival) compared with trastuzumab as an adjuvant treatment in people with HER2-positive early breast cancer who have residual disease present following neoadjuvant treatment.

November 2018—Binding Site’s Immunologicals Group has introduced highly purified Borrelia and chikungunya glycoprotein antigens for use in IVD manufacturing and research applica-tions and as a component within solid phase ELISA-based immunoassay test procedures.

November 2018—ARUP Laboratories has added seven new genes to its Solid Tumor Mutation Panel by Next Generation Sequencing. The genes added are CTNNB1 (beta catenin), DDR2, MAP2K1, MTOR, NTRK1, ROS1, and TERT.

November 2018—Siemens Healthineers announced that Cincinnati Children’s Hospital Medical Center is the first children’s hospital worldwide to install the Atellica Solution immunoassay and clinical chemistry analyzers.

November 2018—Sakura Finetek USA launched the Accu-Cut SRM 300 LT manual microtome. New features include a four-color LED backlit 3D precision chuck, which increases the contrast between specimens and paraffin without warming the block. Users can visualize translucent biopsies in the block using one or a combination of the four LED colors.

October 2018—Kurin announced the results of clinical data from hospitals that use its FDA-cleared blood culture diversion device. In studies conducted at Crouse Hospital, Syracuse, NY, and Bayfront Health, St. Petersburg, Fla., the hospitals saw an overall reduction—56 percent and 54 percent, respectively—in contaminated blood cultures inclusive of all cultures drawn with or without the device. When a Kurin set was used in the blood collection, Crouse saw an 89 percent reduction in contaminated blood cultures and Bayfront a 90 percent reduction in contaminated cultures. In both cases, the hospitals were already below the three percent national contamination rate benchmark when they began using Kurin. Using the company’s passive diversion technology, the hospitals’ overall contamination rates decreased to 0.8 percent and 1.2 percent, respectively. The company has also released a five-minute documentary film titled Cry Wolf: The Consequences of Blood Culture Contamination. The film addresses the prevalence of blood culture contamination, the clinical impact on patients, and the steep associated costs for hospitals. Cry Wolf can be viewed at www.betterbloodcultures.com.

October 2018—Techlab received FDA 510(k) clearance for its H. Pylori Quik Chek and H. Pylori Chek tests. The tests aim to offer quick and reliable detection of Helicobacter pylori–specific antigen in human fecal specimens.

October 2018—Oxford Gene Technology announced it is selling its Cytocell fluorescence in situ hybridization products through several affiliates of Sysmex Corp. in Europe. “The move is a testament to the ongoing successful integration of the two companies and commitment to combine efforts to support and serve end users,” according to a press release from OGT.

October 2018—The Project Santa Fe Foundation and LTS Health announced a collaboration to build awareness of the Clinical Lab 2.0 initiative both through the development of an online crowdsourcing platform to facilitate an international conversation and through LTS Health’s organizational footprint in the U.S., U.K., Middle East, and Africa.

October 2018—Nova Biomedical’s StatStrip Glucose Hospital Meter System has been cleared by the FDA for fingerstick capillary testing with critically ill patients. The FDA granted this 510(k) clearance to StatStrip after extensive prospective and retrospective studies were performed.

October 2018—Hologic received FDA clearance for its group B Streptococcus assay on the Panther Fusion system. The Panther Fusion GBS assay is a real-time PCR assay for the qualitative detection of group B strep in antepartum women with dual-target detection of Cfb and SIP genes.

October 2018—Bio-Rad announced the launch of recombinant beta-2 microglobulin from the company’s line of critical raw materials. This recombinant sourced tumor marker protein offers consistency and security over materials harvested from human sources.

October 2018—Beckman Coulter filed a submission for 510(k) clearance with the FDA for its Early Sepsis Indicator, offered as part of a standard CBC with differential test.

October 2018—The Food and Drug Administration approved moxetumomab pasudotox-tdfk (Lumoxity, AstraZeneca), a CD22-directed cytotoxin indicated for adult patients with relapsed or refractory hairy cell leukemia who received at least two prior systemic therapies, including treatment with a purine nucleoside analog.

October 2018—PerkinElmer announced that its Euro­immun ANCA IFA and Europlus Granulocyte Mosaic assays for use with its EuroPattern microscope have received 510(k) clearance from the FDA. The Euro­immun IFA Granulocyte assays are designed as indirect immunofluorescence tests for the qualitative or semiquantitative determination of antineutrophil cytoplasmic antibodies of immunoglobulin class IgG in human serum.

October 2018—EliTechGroup Biomedical Systems released its FDA-cleared Macroduct Advanced Sweat Collection System for use in the diagnosis of cystic fibrosis. The system includes a touchscreen user interface with step-by-step graphical instructions that help standardize pilocarpine iontophoresis and sweat collection.

October 2018—Gold Standard Diagnostics announced FDA clearance of its Borrelia burgdorferi IgG/IgM ELISA assay. The test is intended as an initial screening assay in the CDC-recommended two-step testing for evidence of antibodies against the Lyme disease bacteria.

October 2018—Natera announced it has partnered with Fox Chase Cancer Center to assess the Signatera (RUO) ctDNA assay for recurrence monitoring of kidney cancer.

October 2018—BacterioScan received FDA 510(k) clearance for its 216Dx Urinary Tract Infection detection system for the detection of bacterial UTIs. The system uses an advanced laser sensor to rapidly detect infections, reducing lab turnaround time to three hours.

October 2018—Vidan Diagnostics announced the availability of its glucose test for the Lucid­plus β-Ketone plus Glucose Monitoring System.

October 2018—MDxHealth announced that a study validating the cost-effectiveness of Select­MDx for Prostate Cancer has been published in Prostate Cancer and Prostatic Diseases. The study evaluates the potential cost-effectiveness of SelectMDx, a noninvasive liquid biopsy test to identify patients at increased risk of aggressive prostate cancer, in a population of men from France, Germany, Italy, and Spain with elevated prostate specific antigen.

October 2018—LGC Maine Standards announced the release of its Validate hsTnT kit for Roche Cobas. The kit, in a human serum matrix, is a linearity and calibration verification product that targets Roche’s Troponin T Gen 5 Stat (TnTG5) assay range.

October 2018—Flagship Biosciences announced that its Muscle­Map algorithm that supports therapeutic development for Duchenne muscular dystrophy has been validated to be as effective as manual pathology. The study was published in the Archives of Pathology & Laboratory Medicine.

October 2018—Beckman Coulter launched its DURA Innovations Cost Benefit Calculator Tool, which allows flow cytometry customers to analyze areas of waste in the laboratory. The Cost Benefit Calculator helps the laboratory achieve greater efficiencies by identifying at least eight significant sources of waste.

October 2018—Qiagen announced a collaboration with SRL, a large clinical testing laboratory company in Japan, to prepare for introducing new companion diagnostics simultaneously with new drug approvals. The nonexclusive master collaboration agreement for clinical laboratory research services will enable rapid implementation by SRL of Qiagen’s companion diagnostic workflows upon approval of the drugs and tests by Japan’s Pharmaceuticals and Medical Devices Agency.

September 2018—Agios Pharmaceuticals announced that Tibsovo (ivosidenib) was granted FDA approval for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 mutation, as detected by an FDA-approved test. Tibsovo is an oral, targeted inhibitor of the IDH1 enzyme. The efficacy of the drug was studied in a single-arm trial of 174 adult patients with relapsed or refractory AML with an IDH1 mutation. The trial measured the percentage of patients with no evidence of disease and full recovery of blood counts after treatment, as well as patients with no evidence of disease and partial recovery of blood counts after treatment. With a median follow-up of 8.3 months, 32.8 percent of patients experienced complete remission or complete remission with partial hematologic recovery that lasted a median 8.2 months. Of the 110 patients who required transfusions of blood or platelets due to AML at the start of the study, 37 percent went at least 56 days without requiring a transfusion after treatment with Tibsovo.

September 2018—Roche announced the result of a collaboration with the University of Missouri School of Medicine to implement the company’s Navify tumor board solution, cloud-based clinical workflow and decision-support software to assist with cancer patient case reviews in tumor board and multidisciplinary team meetings.

September 2018—PerkinElmer has received FDA 510(k) clearance for its NeoLSD MSMS kit, an in vitro diagnostic that uses tandem mass spectrometry to screen for six lysosomal storage disorders in newborns via a single dried blood spot sample. The kit is intended for the quantitative measurement of the activity of the enzymes acid β-glucocerebrosidase, acid sphingomyelinase, acid α-glucosidase, β-galactocerebrosidase, α-galactosidase A, ...

September 2018—Leica Biosystems introduced the Bond Rx next-generation research stainer. The system offers greater flexibility when optimizing conditions for a variety of test types including immunofluorescence, immunohistochemistry, fluorescence in situ hybridization, tyramide signal amplification, multiplexing, and other emerging tests.

September 2018—Inova Diagnostics announced FDA clearance of its Quanta Flash HMGCR for use on its Bio-Flash random access chemiluminescent system.

September 2018—Beckman Coulter announced commercialization of its DxM MicroScan WalkAway system, a diagnostic solution for bacterial identification and antibiotic susceptibility testing that uses direct minimum inhibitory concentrations for detection of antimicrobial resistance.

September 2018—Novartis announced FDA approval for Kisqali (ribociclib) for women with hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer.

September 2018—Agilent Technologies has entered into a definitive agreement to acquire ProZyme, a provider of glycan analysis reagents, kits, and standards. The acquisition will expand Agilent’s portfolio of biopharma consumables.

September 2018—Oxford Gene Technology launched its SureSeq Interpret software, designed to be used with SureSeq NGS panels, to analyze and visualize a range of mutation types and structural variants. The software rapidly processes sequencing data and delivers accurate mutation calling with 100 percent sensitivity and 99.9 percent specificity at >1 percent variant allele frequency.

September 2018—LGC Maine Standards’ Validate IBC linearity and calibration verification kit for Ortho Vitros analyzers is now available. The liquid, ready-to-use kit, in a human serum matrix, evaluates total iron binding capacity.

September 2018—The Clinical and Laboratory Standards Institute announced the publication of “EP34—Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking, 1st ed.” EP34 provides recommendations for establishing a dilution scheme to be used for patient specimens that contain measurand concentrations in the extended measuring interval above a measurement procedure’s upper limit of quantitation.

September 2018—Binding Site’s Immunologicals Group announced a line of highly purified TORCH antigens for use in in vitro diagnostic manufacturing and research applications.

September 2018—Qiagen announced a partnership with multiple organizations to support creating a worldwide genomics campus in Manchester, U.K., for innovation, life sciences, translational science, and molecular diagnostics. Qiagen is working with Health Innovation Manchester to bring together public, academic, and clinical resources to develop the Genomic Health Innovation Campus, anchored by Qiagen’s European Centre of Excellence for Precision Medicine and hub for diagnostics development.

September 2018—The Anatomical Pathology Patient Interest Association, a nonprofit professional membership organization focused on advancing patient safety, quality, standards, and accessibility of care in anatomical pathology, is looking for new members.

September 2018—Microbiologics has launched a series of panels for verification and routine quality control of common molecular assays.

September 2018—Inova Diagnostics announced FDA clearance of its Quanta Flash HMGCR for use on its Bio-Flash random access chemiluminescent system.

September 2018—Oxford Gene Technology launched its SureSeq Interpret software, designed to be used with SureSeq NGS panels, to analyze and visualize a range of mutation types and structural variants. The software rapidly processes sequencing data and delivers accurate mutation calling with 100 percent sensitivity and 99.9 percent specificity at >1 percent variant allele frequency.

September 2018—Qiagen has introduced next-generation sequencing solutions for a range of hereditary diseases on its GeneReader NGS System.

September 2018—Siemens Healthineers announced FDA clearance of its High-Sensitivity Troponin I assays (TnIH) for its Atellica IM and Advia Centaur XP/XPT in vitro diagnostic analyzers to aid in the early diagnosis of myocardial infarctions.

September 2018—Quidel received 510(k) clearance from the FDA to market its Solana Bordetella Complete Assay, a molecular diagnostic assay for use with the Solana instrument for the qualitative detection and differentiation of Bordetella pertussis and Bordetella parapertussis nucleic acids isolated from nasopharyngeal swab specimens.

September 2018—NeuMoDx Molecular announced it has received FDA 510(k) clearance for its NeuMoDx 288 Molecular System and NeuMoDx GBS Assay. The fully automated NeuMoDx 288 is a scalable platform that integrates the diagnostic process, from extraction to detection, in approximately one hour. The analyzer can load up to 288 patient samples in a continuous random-access mode and features a walkaway time of more than six hours.

August 2018—Binding Site’s Immunologicals Group has added infectious and contagious disease state sera and plasma products to its line of products. The human-based serum/plasma biological materials cover a variety of infectious and contagious disease state conditions, including Epstein-Barr virus, influenza, measles, mumps, TORCH, and West Nile. Evaluation samples are available and all materials come in bulk formats for use in the manufacturing of calibration and quality control materials. The company offers comprehensive data on analyte positives and negatives along with a certificate of analysis. In a separate release, the Immunologicals Group announced it has expanded its antibody and antigen product offerings for human coagulation and complement applications.

August 2018—Aquaro Histology announced the launch of the Aquaro Wishbone blade-handling tool. The handheld tool allows histologists to remove and dispose of blades, as well as insert and align them, without having to touch the blade.

August 2018—Natera announced a research collaboration with the Institut Jules Bordet, in Brussels, using the company’s Signatera research-use-only circulating tumor DNA assay to evaluate molecular response and minimal residual disease in women with early stage breast cancer.

August 2018—Luxembourg-based Advanced Biological Laboratories has signed a definitive agreement to acquire CDL Pharma. CDL Pharma, headquartered in France, provides biological sample management solutions in clinical research for pharmaceutical laboratories, contact research organizations, biotechnology companies, and others.

August 2018—Qiagen launched the QIAseq 16S/ITS Panels and UCP Multiplex PCR Kit with a new generation of reagents to enable accurate microbial community profiling from complex microbiome samples. The UCP Multiplex PCR Kit is a standalone product as well as a component of the QIAseq 16S/ITS Panels.

August 2018—Hologic has obtained approval from Health Canada for its Panther Fusion system and Panther Fusion assays for respiratory virus infections. The Panther Fusion module adds the capacity to run PCR assays in addition to tests based on transcription-mediated amplification, the proprietary Hologic chemistry that powers the company’s Aptima brand.

August 2018—Agena Bioscience has entered into a commercial partnership agreement with Zhejiang Dian Diagnostics, an independent medical laboratories provider headquartered in Hangzhou, China.

August 2018—Agilent Technologies announced that the FDA has approved its Dako PD-L1 IHC 22C3 pharmDx assay for expanded use. PD-L1 IHC 22C3 pharmDx is a laboratory test doctors can use to identify the protein programmed cell death ligand 1 in tumor tissue obtained from patients with lung and gastric cancer.

August 2018—MilliporeSigma has entered into an agreement with HistoCyte Laboratories (Tyne, U.K.) to be the exclusive multinational distributor of HistoCyte’s cell line reference products for immunohistochemistry and in situ hybridization.

August 2018—Ortho Clinical Diagnostics received the CE mark for the Ortho Vitros XT 7600 integrated chemistry system. The digital chemistry is based on three technologies: dry slide, microslide, and digital imaging. Dry slide technology does not require water to run, which eliminates the risk of poor water quality affecting test results.

August 2018—Array BioPharma announced that the FDA has approved Braftovi (encorafenib) capsules in combination with Mektovi (binimetinib) tablets for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or BRAF V600K mutation, as detected by an FDA-approved test.

August 2018—LGC Maine Standards released its Validate Procalcitonin linearity and calibration verification kit for Abbott Architect analyzers.

August 2018—EliTechGroup and R-Biopharm announced an agreement in which the two companies will develop, produce, and market real-time PCR reagents.

August 2018—Meridian Life Science released Japanese encephalitis virus pairs suitable for use in ELISAs and immunofluorescence assays. The product is specific for the nonstructural protein 1 (NS1) and exhibits no cross-reactivity with other flaviviruses, including tick-borne encephalitis, yellow fever, West Nile, dengue, Zika, and chikungunya.

August 2018—The FDA has approved Senseonics Holdings’ Eversense Continuous Glucose Monitoring System for adults age 18 and older with diabetes. The system features an implantable glucose sensor and provides long-term continuous monitoring for up to three months.

July 2018—Arlington Scientific announced it has received FDA 510(k) clearance for its ASI Evolution, a fully automated nontreponemal syphilis system for diagnostic testing and blood donor screening.

July 2018—CARB-X has awarded Specific Diagnostics up to $1.7 million to support the development of the company’s antibiotic susceptibility testing system. Up to $1.7 million more could be awarded based on achievement of project milestones. Specific’s AST instrument determines phenotypic antibiotic susceptibility within hours of blood infection.

July 2018—Cancer Genetics announced it has received special 510(k) clearance from the FDA for its Tissue of Origin test following modifications made to test reagents and software.

July 2018—Bio-Rad Laboratories has launched its Liquichek AMH Control for reproductive health testing.

July 2018—SpeeDx’s ResistancePlus MG Positive Control kit has been cleared by the FDA.

July 2018—Biocept has launched its CEE-Sure blood collection tubes for research use only, and internationally distributed through VWR. CEE-Sure BCTs allow for the intact transport of liquid biopsy samples at room temperature.

July 2018—Immucor announced its next-generation, fully automated Echo Lumena received FDA clearance. Echo Lumena is the company’s fifth-generation benchtop immunohematology instrument, designed for small- to mid-volume laboratories.

July 2018—ChromaCode announced the publication of studies from Dartmouth-Hitchcock Medical Center and USC’s Keck School of Medicine highlighting the utility of the company’s HDPCR chemistry and the performance of the HDPCR respiratory assay, for research use only.

July 2018—Becton Dickinson introduced several informatics and automation solutions for clinical laboratories at the European Congress of Clinical Microbiology and Infectious Diseases in Madrid, in April.

July 2018—Siemens Healthineers completed the first U.S. installation of its Atellica Solution immunoassay and clinical chemistry analyzers connected to Aptio Automation at Access Medical Laboratories in Jupiter, Fla.

July 2018—FDA granted in June accelerated approval to pembrolizumab (Keytruda, Merck) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma or for patients who have relapsed after two or more prior lines of therapy.

July 2018—LGC Maine Standards announced that its Validate Fibrinogen for linearity and calibration verification is available on Instrumentation Laboratory’s ACL Top 500, Siemens Healthineers’ Sysmex CS-2500, and Diagnostica Stago’s STA-R Evolution hemostasis test systems.

July 2018—Streck and Diesse Diagnostica Senese have introduced the Cube 30 Touch, an automated instrument for high-volume erythrocyte sedimentation rate testing in EDTA tubes.

July 2018—Qiagen announced the European launch of its QIAstat-Dx, a next-generation multiplex molecular diagnostic that provides a one-step, fully integrated molecular analysis of common syndromes as tested for in syndromes in infections, oncology, and other diseases.

July 2018—Beckman Coulter announced its Early Sepsis Indicator received the CE mark. The Early Sepsis Indicator is a hematology-based solution designed to alert emergency department clinicians to the possibility of sepsis or risk of developing sepsis and is to be offered as part of a routine CBC with differential test.

July 2018—DiaSorin Molecular introduced three primer pairs for use in laboratory-developed molecular tests.

July 2018—Quantimetrix announced the launch of its Dipper POCT Single-Use Liquid Urinalysis Dipstick Control for use in a variety of testing environments, including central labs, reference labs, nursing stations, and doctors’ offices.

July 2018—Meridian Life Science launched TruBlock Ready, a broad-acting HAMA blocker that is ready to use within a single dilution step.

July 2018—Binding Site’s Immunologicals Group has added three parainfluenza virus antigens for in vitro diagnostic manufacturing and research applications. The Parainfluenza Virus Type 1, Type 2, and Type 3 antigens have been designed for use in solid phase enzyme immunoassay test procedures, especially ELISAs.

July 2018—Fujirebio has entered into an agreement with Janssen Pharmaceuticals to develop and commercialize an amyloid β 42/40 ratio assay. The assay will run on the Lumipulse series

July 2018—PLUGS (Patient-centered Laboratory Utilization Guidance Services) and Metis Genetics announced a partnership to provide case review services via Gene­Test­Advisor, a case management solution for genetic testing to support health care systems and insurance payers in effectively administering their genetic testing caseload.

June 2018—Sakura Finetek USA launched its Tissue-Tek Prisma Plus Automated Slide Stainer, which has a throughput of 530 slides per hour.

June 2018—Beckman Coulter Diagnostics announced it received the CE mark for its DxH 520 hematology analyzer, a 5-part differential, closed-tube analyzer for small-volume laboratories.

June 2018—EKF Diagnostics announced FDA 510(k) clearance and CLIA waiver for its Dia­Spect handheld hemoglobin analyzer.

June 2018—Curetis has been granted de novo clearance by the FDA to market the Unyvero System and Lower Respiratory Tract Infection Application Cartridge in the U.S.

June 2018—MDxHealth announced that its ConfirmMDx is included in the 2018 European Association of Urology guidelines. Inclusion in the guidelines will facilitate adoption of the test in EU member state-specific guidelines, and the company will pursue CE marking of the test.

June 2018—Enzo Life Sciences introduced three clinically relevant antibodies for immunohistochemistry detection.

June 2018—Nova Biomedical has opened a sales and after-sales support subsidiary in the canton of Zug, outside of Zurich.

June 2018—Thermo Fisher Scientific has signed agreements with Daiichi Sankyo and Takeda Pharmaceuticals designed to expand the clinical utility of Oncomine Dx Target Test in support of clinical trials and drug development programs at the Japanese companies.

June 2018—Sanquin and Abbott announced they signed a multiyear contract for the supply of primary serological equipment and consumables, including Abbott’s Alinity s system, for blood and plasma screening.

June 2018—LGC Maine Standards released its Validate Body Fluids, a comprehensive body fluids kit for linearity and calibration verification.

June 2018—The FDA has granted a de novo request to Dexcom for its Dexcom G6 integrated continuous glucose monitoring system for determining blood glucose levels for people with diabetes ages two and older.

June 2018—MilliporeSigma launched its CellStream flow cytometry system at the CYTO 2018 conference, April 28–May 2, in Prague. The CellStream is a benchtop, customizable flow cytometer that uses a camera for detection.

June 2018—Phenomenex introduced Strata-X-Drug B Plus, a solid-phase extraction sample preparation product for urine drug testing in clinical and forensic toxicology laboratories.

June 2018—DiaSorin received clearance from the FDA to market the Liaison Brahms PCT II Gen assay for the quantitative determination of procalcitonin.

June 2018—Aurora Diagnostics announced that Cascade Pathology Services, a physician-owned multispecialty pathology practice providing surgical pathology services to hospitals and physician groups in the Portland area, has joined Aurora Diagnostics.

June 2018—Beckman Coulter Diagnostics launched its Access Sensitive Estradiol in the U.S. and in the majority of worldwide markets. The assay aims to help laboratories deliver more accurate results for patients seeking answers to reproductive health questions.

June 2018—SciGene introduced the CytoBrite Plus Slide Incubation System, a programmable FISH hybridizer with onboard temperature verification of each slide position, as required by CAP cytogenetics checklist item CYG.33950.

June 2018—Medtronic received FDA approval for its Guardian Connect continuous glucose monitoring system for people with diabetes ages 14 to 75 years.

June 2018—Becton Dickinson announced the commercial availability of the CE-IVD-marked PAXgene Blood ccfDNA tube within the European Economic Area and Switzerland.

June 2018—Binding Site’s Immunologicals Group announced the availability of affinity-purified, unconjugated, anti-human antibodies to the IgG subclasses, including IgG1, IgG2, IgG3, and IgG4, for IVD research use in solid phase enzyme immunoassay based test methods, especially ELISAs, and other potential testing applications.

June 2018—Rosetta Genomics’ stockholders have approved the acquisition of the company by Genoptix, which will immediately begin marketing, selling, and distributing Rosetta Genomics’ products.

June 2018—Sekisui Diagnostics has partnered with Qualigen to distribute the FastPack IP System, Qualigen’s POC immunoassay testing system.

May 2018—AdvantEdge Healthcare Solutions, a medical billing company, has acquired Professional Management, Inc., a Baltimore-based medical billing company that provides billing services to pathology, radiology, and emergency medicine physician groups.

May 2018—Thermo Fisher Scientific announced its Oncomine Dx Target Test has been approved for coverage by the Centers for Medicare and Medicaid Services as part of the agency’s national coverage determination for next-generation sequencing in vitro diagnostic tests.

May 2018—ArcherDx and Ambry Genetics announced a partnership in which Ambry will provide biopharma sequencing services using ArcherDx’s next-generation sequencing assays. Ambry Genetics will utilize Archer Immunoverse and VariantPlex NGS assays to provide large-scale immune repertoire analysis and chimeric antigen receptor T-cell manufacturing characterization and pharmacodynamics to biopharma customers.

May 2018—Integrated Diagnostics announced the e-publication of full results of a large prospective clinical trial validating its Xpresys Lung 2 in Chest, titled “Assessment of plasma proteomics biomarker’s ability to distinguish benign from malignant lung nodules: results of the PANOPTIC (PulmonAry NOdule Plasma proTeomIc Classifier) trial”.

May 2018—Sebia launched two CE-marked serum free light chain assays, Sebia FLC Kappa and Sebia FLC Lambda, for multiple myeloma testing. The two assays aim to provide more consistent results by overcoming the challenges in analytical performance and coherence encountered in current testing methods.

May 2018—Agena Bioscience and Simcere Diagnostics signed a strategic partnership agreement to expand the use of Agena’s Mass­Array System for companion diagnostics and pharmacogenetic testing in China.

May 2018—Intrinsic LifeSciences released its Erythroferrone IE ELISA kit for research use only. It is designed for quantification of human erythroferrone in serum and does not contain mercaptoethanol or azide- or mercury-based preservatives.

May 2018—Thermo Fisher Scientific has acquired IntegenX, a forensic DNA testing firm. IntegenX products include the RapidHIT platforms, software analysis tools, and related consumables that are compatible with Thermo Fisher’s short tandem repeat chemistries for human identification.

May 2018—Randox Laboratories unveiled Vivalytic, a molecular diagnostics platform, with Bosch Healthcare Solutions at the 28th European Congress of Clinical Microbiology and Infectious Diseases, April 21–24, in Madrid.

May 2018—Binding Site’s Immunologicals Group announced the addition of sheep anti-human, monkey adsorbed, IgG polyclonal antibodies designed for use with a variety of testing procedures, especially enzyme immunoassays, for research applications.

May 2018—Qiagen and Natera will partner to develop cell-free DNA assays, including for prenatal screening, for use on the Qiagen GeneReader NGS System.

May 2018—Technopath Clinical Diagnostics, an Ireland-based developer and manufacturer of total quality control solutions for clinical laboratories, and Beckman Coulter Diagnostics signed a long-term supply and distribution agreement.

May 2018—Foundation Medicine announced that FoundationOne CDx, an FDA-approved comprehensive genomic profiling assay for all solid tumors incorporating multiple companion diagnostics, is available in the United States. FoundationOne CDx is a test for patients with advanced cancer and is offered as a nationally covered benefit across all solid tumors for Medicare and Medicare Advantage beneficiaries who meet eligibility requirements.

May 2018—Helmer Scientific announced the release of its FDA 510(k)-cleared, next-generation automatic cell washing system, the UltraCW II, for hospital blood banks and clinical laboratories. The UltraCW II automates steps within typical tube testing blood bank workflows. It removes plasma and unwanted antibodies from blood cells for pretransfusion testing procedures—ABO and Rh grouping, antibody identification, and cross-matching.