Vidas SARS-CoV-2 antibody serology tests get EUA
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.
Webinars and Sponsored Roundtables — Register Now
Wednesday, September 23, 2026. 12 PM-1 PM ET
Roundtable presenters Dr. David Sacks MB, ChB, FRCPath, Chairman, Steering Committee National Glycohemoglobin Standardization Program (NGSP), and Priya Sivaraman, PhD, Senior Technical Product Manager, Tosoh Bioscience.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Thursday, September 24, 2026 11 AM-12 PM CT
This session explores the evolving role of RAS in precision oncology, from the biology of RAS mutations to the expanding landscape of targeted therapies. Through expert presentations, real-world case discussions, and interactive audience polling, participants will examine best practices for RAS biomarker testing across solid tumors, including lung, colorectal, and pancreatic cancers. The session will highlight practical considerations for tissue and liquid biopsy, strategies to address testing gaps, and the importance of multidisciplinary collaboration to ensure timely identification of patients who may benefit from RAS-targeted therapies.
Webinar presenters David Braxton, MD, Chief of Molecular Pathology Services, Hoag Family Cancer Institute & Hoag Memorial Hospital Presbyterian, and Carlos Becerra, MD, Research Director for Medical Oncology, Margaret Given Larkin Endowed Chair for Developmental Cancer Therapeutics, Hoag Memorial Hospital Presbyterian.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Wednesday, September 30, 2026. 1 PM-1:30 PM ET
Roundtable presenters John Longshore, PhD, Head of Scientific Affairs, Global Oncology Diagnostics, AstraZeneca, and Flora Berisha, MS, Executive Director, Global Head of Diagnostic Partnering and Development, Johnson & Johnson Innovative Medicine, and Mark D. Ewalt, MD, Associate Medical Director for Laboratory Operations, Diagnostic Molecular Pathology, Molecular Diagnostics Service, Department of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, and Isabel Preeshagul, DO, MBS, Thoracic Medical Oncologist, Memorial Sloan Kettering Cancer Center.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Tuesday, October 20, 2026 11 AM-12 PM ET
Hear experts review the biological and clinical significance of the HER2 expression continuum in breast tissue, providing a clearer understanding of how these variations might impact diagnosis, and discuss the emerging importance of documenting HER2-low and HER2-ultralow categories using a validated IHC assay.
Webinar presenters Keith Wharton, MD, PhD, Global Medical Affairs Leader–Pathology,
Roche Diagnostics Solutions, and Hannah Y. Wen, MD, PhD, Director, Breast Pathology Fellowship, Associate Team Leader, Breast Pathology Team, Attending Pathologist, Memorial Sloan Kettering Cancer Center.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
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Verichem calibration verification kits, standards
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.
Access SARS-CoV-2 IgG assay gets EUA
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.
Alpha-Tec launches SARS-CoV-2, HPV controls
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.
Simplexa Congenital CMV Direct kit gets CE mark
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.
Randox unveils cytokine tests
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.
Illumina receives EUA for sequencing-based COVID-19 dx
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.
FDA issues first EUA for sample pooling in dx testing
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.
Microbiologics SARS-CoV-2 quality controls
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.
BD launches POC SARS-CoV-2 antigen test
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.