Access PCT cleared by the FDA
Feb. 13, 2020—Beckman Coulter’s Access PCT assay has received FDA 510(k) clearance and is available for sale in the United States.
Webinars and Sponsored Roundtables — Register Now
Thursday, October 29, 2026, 1 PM-2 PM ET
Hear an expert discuss the evolving role of PD-L1 testing in HNSCC and ovarian cancer.
Webinar presenter Georgios Deftereos, MD, Professor of Pathology, Associate Director of the Clinical Cancer Genomics Laboratory, Director of Molecular Cytopathology, University of California, San Francisco
CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from Agilent.
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
Tuesday, November 10, 2026, 1 PM-2 PM ET
Join us for a session to help improve diagnostic accuracy in your practice when scoring HER2 IHC 0 with faint, incomplete membrane staining in ≤10% of tumor cells vs IHC 0 with no membrane staining detected in patients with mBC.
Webinar presenter Jeffrey Gregg, MD, University of Nevada
CAP TODAY does not endorse any of the products or services named within. This program is being sponsored by Daiichi Sankyo, Inc. and AstraZeneca. The speaker is being compensated for the presentation. The program is not CME accredited and may not be used for CME accreditation.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Monday, November 16, 2026, 12:30 PM-2 PM ET
Hear experts discuss a multidisciplinary approach to oncopathology for HER2
assessments for solid tumors in the absence of a companion diagnostic.
Webinar presenters Funda Meric-Bernstam, MD, Chair, Department of Investigational Cancer Therapeutics Medical Director, Institute for Personalized Cancer Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas, and Emina E. Torlakovic, MD, PhD, College of Medicine, University of Saskatchewan, Canadian Biomarker Quality Assurance, Saskatoon, Saskatchewan, Canada, and Carol Cheung, MD, PhD, JD, FRCPC, Deputy Director, Canadian Biomarker Quality, Assurance—Programme canadien d’assurance de la qualité des biomarqueurs
CAP TODAY does not endorse any of the products or services named within. This program is being sponsored by Daiichi Sankyo, Inc. and AstraZeneca. The speaker is being compensated for the presentation. The program is not CME accredited and may not be used for CME accreditation.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
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Interactive Product Guides
Industry News
Siemens adds ARK Fentanyl Assay to its testing menu
Jan. 27, 2020—Siemens Healthineers has added the ARK Fentanyl Assay to its testing menu.
OGT launches NGS panel for chronic lymphocytic leukemia
Jan. 15, 2020—Oxford Gene Technology launched its SureSeq CLL + CNV Panel, a next-generation sequencing panel designed to detect 12 key genes and five chromosomal regions implicated in chronic lymphocytic leukemia progression.
Applied BioCode respiratory pathogen panel gets FDA clearance
Jan. 9, 2020—Applied BioCode has received FDA 510(k) clearance for its BioCode Respiratory Pathogen Panel for use on the company’s BioCode MDx-3000 system.
FDA clears Curetis Unyvero LRT for BAL specimens
Jan. 7, 2020—Curetis announced it has received FDA 510(k) clearance to market its Unyvero LRT Lower Respiratory Tract application cartridge for use with bronchoalveolar lavage samples to diagnose lower respiratory tract infections such as pneumonia.
FDA authorizes marketing of Roche MRSA diagnostic test
Dec. 27, 2019—The FDA authorized marketing of the Cobas VivoDx MRSA (Roche) diagnostic test based on bacterial viability and novel technology to detect methicillin-resistant Staphylococcus aureus bacterial colonization.
Roche launches Zika test to markets accepting the CE mark
Dec. 23, 2019—Roche announced the CE-IVD launch of the Cobas Zika test for use on the Cobas 6800/8800 systems. The test detects Zika virus RNA in samples of human plasma and is intended for use in screening blood donations.
DiaSorin receives FDA clearance for Simplexa VZV Swab Direct
Dec. 19, 2019—DiaSorin Molecular has received FDA clearance for its Simplexa VZV Swab Direct assay. The CLIA moderate-complexity assay is designed for use on the Liaison MDX instrument to detect varicella-zoster virus DNA from cutaneous and mucocutaneous swab specimens.
Veracyte acquires exclusive license to NanoString platform
Dec. 5, 2019—Veracyte and NanoString have entered into an agreement in which Veracyte has obtained exclusive global rights to develop and commercialize diagnostic tests on NanoString’s nCounter Flex system.
Qiagen, DiaSorin receive FDA approval for Liaison QFT-Plus
Dec. 2, 2019—Qiagen and DiaSorin announced FDA approval of the Liaison QuantiFeron-TB Plus Test developed by Qiagen and DiaSorin and the U.S. launch of an automated workflow for QFT-Plus on Liaison platforms.