Roche BKV test FDA cleared on Cobas 6800/8800 systems
Sept. 9, 2020—Roche received FDA 510(k) clearance for the Cobas BKV test on the Cobas 6800 and 8800 systems.
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
CAP TODAY does not endorse any of the products or services named within. The roundtable is made possible by a special educational grant from Tosoh Bioscience Inc.
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
CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from OncoLens and Diaceutics.
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
CAP TODAY does not endorse any of the products or services named within. The roundtable is made possible by a special educational grant from Pillar Biosciences.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Thursday, October 1, 2026 1 PM-2 PM ET
This presentation will explore the value of in-house CGP, offer insights into the benefits and drawbacks of incorporation, and provide information about important practical factors when considering in-house implementation of CGP.
Webinar presenter Allison M. Cushman-Vokoun, MD, PhD, FCAP, Medical Director, Molecular Diagnostics and Personalized Medicine Laboratory, Director, Division of Diagnostic Molecular Pathology and Human Genetics, Henry F. Krous Professor of Pathology, University of Nebraska Medical Center
CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from Illumina.
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
CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from Roche.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
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
CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from Diaceutics.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
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Interactive Product Guides
Industry News
FDA clears Simplexa Flu A/B & RSV Direct Gen II assay
Sept. 8, 2020—DiaSorin Molecular received FDA clearance for its Simplexa Flu A/B & RSV Direct Gen II kit.
Roche receives EUA for Cobas SARS-CoV-2 & Influenza A/B test
Sept. 4, 2020—Roche announced that the Cobas SARS-CoV-2 & Influenza A/B Test for use on the Cobas 6800/8800 systems has received emergency use authorization from the FDA.
Roche HIV 1/2 qualitative test approved on Cobas 6800/8800
Sept. 1, 2020—Roche announced FDA approval for the Cobas HIV-1/HIV-2 Qualitative test for use on the fully automated Cobas 6800/8800 systems in the United States.
Abbott’s BinaxNow 15-minute COVID-19 antigen test gets EUA
Aug. 27, 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.
Beckman Coulter launches SARS-CoV-2 IgM antibody test
Aug. 26, 2020—Beckman Coulter launched its Access SARS-CoV-2 Immunoglobulin M assay.
Qiagen expands coronavirus NGS, software solutions
Aug. 25, 2020—Qiagen has launched the QIAseq SARS-CoV-2 Primer Panel for next-generation sequencing of the novel coronavirus genome and integrated analysis and interpretation workflows for insights into the evolution and spread of the virus.
Diazyme gets EUA for COVID-19 antibody test
Aug. 24, 2020—Diazyme Laboratories announced receiving FDA emergency use authorization for the Diazyme DZ-Lite SARS-CoV-2 IgM CLIA test.
Adaptive gets expanded FDA clearance for ClonoSEQ assay
Aug. 20, 2020—Adaptive Biotechnologies received FDA clearance for its ClonoSEQ assay to detect and monitor minimal residual disease in blood or bone marrow from patients with chronic lymphocytic leukemia.
Qiagen web series on biomarker profiling from FFPE samples
Aug. 18, 2020—Qiagen is offering a four-part web seminar series in which the latest tips and tricks for successful biomarker profiling from FFPE samples will be discussed.