Seegene submits SARS-CoV-2, flu A/B, RSV assay for EUA
March 2, 2021—Seegene announced it has submitted its Allplex SARS-CoV-2/FluA/FluB/RSV Assay to the FDA for emergency use authorization.
Webinars and Sponsored Roundtables — Register Now
Thursday, April 30, 2026, 11:00 AM–12:00 PM ET
Hear an expert discuss how Memorial Sloan Kettering Cancer Center (MSKCC) is utilizing
the oncoReveal® Nexus 21-gene panel to redefine turnaround time and actionable insights
in cancer care. Dr. Ewalt shares a perceptive look at the clinical need for rapid, front-line NGS sequencing, and how a unique, purpose built targeted NGS panel (Pillar Biosciences’ oncoReveal Nexus 21 gene Panel) was developed, validated and implemented clinically by Memorial Sloan Kettering Cancer Center (MSK-REACT) to complement their current comprehensive genomic profiling (CGP) approach.
Webinar presenter Mark Ewalt, MD, Associate Medical Director for Laboratory Operations for Diagnostic Molecular Pathology in the Molecular Diagnostics Service, Department of Pathology and Laboratory Medicine, MSKCC.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from Pillar Biosciences.
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
Subspecialties
Interactive Product Guides
Industry News
Adaptive Biotechnologies launches T-Detect COVID test
March 1, 2021—Adaptive Biotechnologies Corp. launched its T-Detect COVID, a clinical T-cell–based test to confirm recent or prior COVID-19 infection.
Hologic completes acquisition of Biotheranostics
Feb. 26, 2021–Hologic has completed its acquisition of Biotheranostics for about $230 million. Biotheranostics develops and markets Breast Cancer Index and CancerType ID, two highly differentiated molecular diagnostic tests for breast and metastatic cancers.
Siemens lab-based CoV2Ag test for high-throughput analyzers
Feb. 25, 2021–Siemens Healthineers announced the company’s laboratory-based SARS-CoV-2 Antigen Assay obtained the CE mark; the test runs on the Atellica IM analyzer, which has the capacity to run 440 tests per hour, and the Advia Centaur XP and XPT immunoassay systems.
Bio-Rad Reliance RT-PCR COVID assays granted EUA
Feb. 23, 2021–Bio-Rad Laboratories announced that its Reliance SARS-CoV-2/FluA/FluB RT-PCR and Reliance SARS-CoV-2 RT-PCR assay kits were granted emergency use authorization by the FDA.
BD gets EUA, CE mark for combo SARS-CoV-2, flu A+B test
Feb. 19, 2021–BD announced FDA emergency use authorization for a molecular diagnostic test for SARS-CoV-2 and influenza A and B that can return results in two to three hours. The test also has been CE marked to the IVD directive.
Visby POC COVID-19 PCR test gets CLIA waiver
Feb. 17, 2021–Visby Medical announced FDA authorization of the company’s rapid PCR COVID-19 test for use at the point of care by organizations with a CLIA certificate of waiver.
Bio-Rad enhances InteliQ QC line
Feb. 12, 2021–Bio-Rad Laboratories has enhanced its InteliQ liquid quality controls product line.
FDA clears Cobas BKV test for urine samples
Feb. 12, 2021–Roche announced FDA 510(k) clearance of stabilized urine samples to be used with the Cobas BKV test on the Cobas 6800/8800 systems.
BioDiscovery releases upgrade to NxClinical software system
Feb. 11, 2021–BioDiscovery has released NxClinical 6.0, the company’s fifth major upgrade to its software for integrated analysis of copy number, sequence variants, and allelic changes obtained from multiple technologies.