FDA clears Promega OncoMate MSI Dx system
July 29, 2021—Promega’s OncoMate MSI Dx analysis system has been cleared by the FDA as an IVD medical device to determine microsatellite instability status in colorectal cancer tumors.
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
July 29, 2021—Promega’s OncoMate MSI Dx analysis system has been cleared by the FDA as an IVD medical device to determine microsatellite instability status in colorectal cancer tumors.
July 20, 2021—Sarstedt introduced its BL 1200 Sort Connect, a preanalytical accessioning and sorting instrument that can be connected to integrated systems or analyzer lines.
July 15, 2021—Werfen announced that its companies, including Instrumentation Laboratory, Inova Diagnostics, and Biokit, are uniting under one name and one brand—Werfen—and a new corporate logo.
July 14, 2021—Bio-Rad launched its Reliance SARS-CoV-2/FluA/FluB RT-PCR Kit (IVD) for European markets after having met the CE-IVD mark requirements.
July 12, 2021—Bruker launched, at the 31st European Congress of Clinical Microbiology and Infectious Diseases products, and methods for its MALDI Biotyper platform.
July 9, 2021—Today the FDA issued an emergency use authorization to Ortho Clinical Diagnostics for the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative test.
June 29, 2021–Inova Diagnostics announced FDA 510(k) clearance of its Aptiva system and Aptiva Celiac Disease IgA assay.
June 24, 2021—Thermo Fisher Scientific launched its CE-IVD-marked TaqPath COVID-19 Fast PCR Combo Kit 2.0.
June 23, 2021—Biocept announced a collaboration with Quest Diagnostics to provide laboratory testing services to Quest patients for its Target Selector NGS-based liquid biopsy targeted lung cancer panel.
June 22, 2021—Epredia and Aiforia announced they have entered into a commercial distribution agreement for Aiforia’s portfolio of preclinical and clinical pathology tools.