Abbott’s 15-minute COVID-19 antigen test gets EUA
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.
Webinars and Sponsored Roundtables — Register Now
Thursday, May 28, 2026, 1:00–2:00 PM ET
This session is designed to improve understanding and application of recent updates to synoptic pathology reporting protocols such as the latest Reporting Template for Reporting Results of Biomarker Testing of Specimens from Patients with Carcinoma of the Breast. These changes reflect evolving clinical guidelines that directly influence diagnostic accuracy and treatment selection in breast cancer care.
Webinar presenters Thaer Khoury, MD, FCAP, Chair, Pathology and Laboratory Medicine, Roswell Park Comprehensive Cancer Cente, and Colin Murphy, CEO of mTuitive.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Wednesday, June 24, 2026, 12:00–1:00 PM ET
Hear an expert discuss the expanded clinical utility of HER2 IHC scoring in metastatic breast cancer and its impact on your practice
Webinar presenters Michelle Shiller, DO, AP, CP, MGP, FACP, Baylor University Medical Center.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
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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.
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.
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.