NeuMoDx gets emergency use authorization for SARS-CoV2 test
April 2, 2020—NeuMoDx Molecular announced that the FDA has issued an emergency use authorization for the NeuMoDx SARS-CoV-2 Assay implemented on NeuMoDx molecular systems.
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Thursday, October 29, 2026, 1 PM-2 PM ET
Hear an expert discuss the evolving role of PD-L1 testing in HNSCC and ovarian cancer.
Webinar presenter Georgios Deftereos, MD, Professor of Pathology, Associate Director of the Clinical Cancer Genomics Laboratory, Director of Molecular Cytopathology, University of California, San Francisco
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Tuesday, November 3, 2026, 1 PM-2 PM ET
Hear an expert discuss the challenges of detecting NRG1 fusions and how RNA-based testing can support more comprehensive fusion identification in clinical practice.
Webinar presenter Benjamin Weinberg, MD, Associate Professor of Medicine and Attending Physician
specializing in gastrointestinal medical oncology
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Tuesday, November 10, 2026, 1 PM-2 PM ET
Join us for a session to help improve diagnostic accuracy in your practice when scoring HER2 IHC 0 with faint, incomplete membrane staining in ≤10% of tumor cells vs IHC 0 with no membrane staining detected in patients with mBC.
Webinar presenter Jeffrey Gregg, MD, University of Nevada
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Monday, November 16, 2026, 12:30 PM-2 PM ET
Hear experts discuss a multidisciplinary approach to oncopathology for HER2
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Webinar presenters Funda Meric-Bernstam, MD, Chair, Department of Investigational Cancer Therapeutics Medical Director, Institute for Personalized Cancer Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas, and Emina E. Torlakovic, MD, PhD, College of Medicine, University of Saskatchewan, Canadian Biomarker Quality Assurance, Saskatoon, Saskatchewan, Canada, and Carol Cheung, MD, PhD, JD, FRCPC, Deputy Director, Canadian Biomarker Quality, Assurance—Programme canadien d’assurance de la qualité des biomarqueurs
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Industry News
Beckman to develop tests to detect coronavirus antibodies
April 2, 2020—Beckman Coulter announced it is developing assays to identify IgM and IgG antibodies to SARS-CoV-2. The assays will be designed for use on any of the company’s high-throughput Access family of immunoassay systems.
FDA clears RapidPoint 500e Blood Gas Analyzer for critically ill
April 2, 2020—Siemens Healthineers announced that its RapidPoint 500e Blood Gas Analyzer has received clearance from the FDA. The analyzer generates blood gas, electrolyte, metabolite, CO-oximetry, and neonatal bilirubin results, which are used to diagnose and monitor critically ill patients in the intensive care unit, operating room, or emergency room.
QIAstat-Dx test kit for SARS-CoV-2 gets EUA
April 1, 2020—Qiagen has received emergency use authorization from the FDA for its QIAstat-Dx Respiratory SARS-CoV-2 Panel test for use in diagnosing patients infected with the novel COVID-19 coronavirus.
Vivalytic test for detecting SARS-CoV-2
April 1, 2020—Randox Laboratories and Bosch Healthcare Solutionswill launch this month the Vivalytic Viral Respiratory Tract Infection Array, which can identify SARS-CoV-2 and differentiate it from nine other respiratory infections with similar symptoms, including influenza and all known coronaviruses.
Abbott announces POC test for COVID-19
April 1, 2020—Abbott announced that the FDA has issued emergency use authorization for its molecular point-of-care test for the detection of novel coronavirus. The test delivers positive results in as few as five minutes and negative results in 13 minutes and runs on the company’s ID Now platform.
Quidel’s Lyra SARS-CoV-2 gets expanded use authorization
March 31, 2020—Quidel’s Lyra SARS-CoV-2 Assay has received expanded emergency use authorization claims from the FDA to allow testing with three additional thermocyclers: Applied Biosystems 7500 Standard, Roche LightCycler 480, and Qiagen Rotor-Gene Q.
BioFire Defense BioFire COVID-19 test gets EUA
March 31, 2020—BioFire Defense, a subsidiary of BioMérieux, has received emergency use authorization by the U.S. Food and Drug Administration for its BioFire COVID-19 test for use in CLIA moderate and high-complexity clinical laboratories to detect SARS-CoV-2.
Envetec 200 system for COVID-19–infected medical waste
March 31, 2020—Northwell Health, in New York, is minimizing the risk of spreading COVID-19 by adopting Technopath Clinical Diagnostics’ on-site medical waste treatment technology for COVID-19–infected medical waste.
Hardy Diagnostics releases rapid test for COVID-19
March 30, 2020—Hardy Diagnostics announced it is a U.S. supplier of the Anti-SARS-CoV-2 Rapid Test, developed by Autobio Diagnostics (Zhengzhou, China).