Beckman Coulter DxA 5000 gets 510(k) clearance
Oct. 11, 2019–Beckman Coulter announced that its DxA 5000 total laboratory automation solution has received FDA 510(k) clearance and is available for sale in the United States.
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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Industry News
Qiagen, Illumina to deliver NGS-based IVD kits
Oct. 9, 2019—Illumina and Qiagen announced a 15-year partnership intended to broaden the availability and use of NGS-based in vitro diagnostic kits, including companion diagnostics, for patient management.
FDA clears Xpert BCR-ABL Ultra
Oct. 7, 2019—Cepheid received clearance from the FDA for Xpert BCR-ABL Ultra for monitoring disease burden in patients with chronic myeloid leukemia. It is the first FDA-cleared test of its kind capable of delivering accurate molecular results from whole blood samples in under three hours, Cepheid said in an Oct. 2 release.
Visiun awarded group purchasing agreement
Oct. 3, 2019—Visiun announced it has been awarded a group purchasing agreement from Premier. The agreement allows Premier members to take advantage of special pricing and terms prenegotiated by Premier for Visiun’s Performance Insight laboratory analytics system.
FDA clears Abbott high sensitivity troponin-I blood test
Oct. 2, 2019—Abbott announced that its Architect Stat High Sensitivity Troponin-I blood test has received clearance from the FDA.
Roche launches Cobas EBV, BKV tests on 6800/8800 systems
Sept. 30, 2019—Roche announced the commercial availability of the Cobas EBV (Epstein-Barr virus) and Cobas BKV (BK virus) tests for use on the Cobas 6800/8800 systems in countries accepting the CE mark. The tests are used to assess transplant patients’ risk of developing disease by these pathogens, which can contribute to organ rejection.
Simplexa VZV Swab Direct assay gets CE mark
Sept. 27, 2019–DiaSorin Molecular received the CE mark for its Simplexa VZV Swab Direct assay. The molecular diagnostic test enables the direct detection of varicella-zoster virus DNA from cutaneous and mucocutaneous swab specimens.
nRichDX unveils high-yield liquid biopsy sample prep platform
Sept. 26, 2019—nRichDX introduced its Revolution System, a high-yield sample prep platform designed to increase liquid biopsy–based test sensitivity by delivering more target input for molecular assays. The target yield increase is accomplished by combining the ability to process a wide range of sample volumes (3–50 mL) with recovery rates of 70–90 percent.
FDA approves Cobas Babesia
Sept. 20, 2019–Roche received FDA approval for the Cobas Babesia test for use on the Cobas 6800 and Cobas 8800 systems. It is a qualitative in vitro nucleic acid screening test for the direct detection of babesia (B. microti, B. duncani, B. divergens, and B. venatorum) DNA and RNA in whole blood samples from individual human donors, including donors of whole blood and blood components, and other living donors.
Nova Biomedical introduces ES Comp Plus Electrolyte System
Sept. 18, 2019—Nova Biomedical announced the release of its Stat Profile Prime ES Comp Plus. The analyzer offers a complete electrolyte profile, including ionized magnesium, and optional serial batch testing on whole blood, serum, or plasma.