CMS finalizes pricing determination for OncoReveal CDx
January 2026—The Centers for Medicare and Medicaid Services has finalized its pricing determination for Pillar Biosciences’ OncoReveal CDx.
Webinars and Sponsored Roundtables — Register Now
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
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
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
Subspecialties
Interactive Product Guides
Marketplace
NEB launches flu A integrated indexing primer module
January 2026—New England Biolabs released its NEBNext Flu A Integrated Indexing Primer Module, designed to streamline and scale the sequencing of influenza A virus from a range of species and sample types using Oxford Nanopore Technologies platforms.
FDA clears QuidelOrtho Vitros hs troponin I assay
January 2026—The FDA has granted QuidelOrtho Corp. 510(k) clearance for the Vitros hs Troponin I Reagent Pack.
Roche launches next-gen Cobas 6800/8800 systems, software
January 2026—Roche launched Cobas 6800/8800 systems version 2.0 and software version 2.0.1, following FDA 510(k) clearance.
FDA clears TruVerus multimodal blood testing instrument
January 2026—Werfen announced its commendation of the publication of a special report underscoring the urgent need to address the risks of undetected in vitro hemolysis.
Thermo Fisher Scientific launches microarray solution
January 2026—Thermo Fisher Scientific has introduced the Applied Biosystems SwiftArrayStudio microarray analyzer, designed for fast and scalable sample analysis.
Proscia’s Access25 available on demand
January 2026—Access25, a virtual event that featured live demos of Proscia Aperture, Proscia’s latest product offering that surfaces patient insights at the moment of diagnosis, is now available on demand by registering at Proscia.com. The event included a life sciences track on how pathology data is accelerating therapeutic development and a clinical laboratories track on how digital pathology is powering new models of patient care. The program featured perspectives from Labcorp, Johnson & Johnson, PathGroup, and more, as well as
FDA qualifies AIM-MASH AI Assist for MASH clinical trials
January 2026—PathAI announced that the Food and Drug Administration has qualified AIM-MASH AI Assist through the drug development tool (DDT) biomarker qualification program for use within a context of use in metabolic dysfunction–associated steatohepatitis (MASH) clinical trials. AIM-MASH AI Assist is the first AI-powered pathology DDT to receive FDA qualification.
OncoMate MSI Dx approved as CDx for Keytruda + Lenvima
January 2026—The FDA has approved the Promega OncoMate MSI Dx analysis system as a companion diagnostic designed to identify patients with microsatellite stable (defined as not MSI-high) endometrial carcinoma who may benefit from treatment with pembrolizumab (Keytruda, Merck) plus lenvatinib (Lenvima, Eisai).
Gold Standard Dx launches AIX1000 2.1
December 2025—Gold Standard Diagnostics has released version 2.1 of its flagship AIX1000 RPR automation platform. This release introduces extra high titer capability, supporting screens and titers up to 1:2048. The expanded titer range aims to empower laboratories to more accurately track antibody levels over time, improving clinical decision-making and supporting public health initiatives focused on syphilis control and eradication. The test system meets the 2024 CDC Laboratory Recommendations for Syphilis Testing.