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 Commercial Conversations — Register Now
Tuesday, November 10, 2026, 1:00 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 Samuel Caughron, MD, FCAP, Chief Strategy Officer, MAWD Pathology, Medical Director of Laboratory, AdventHealth Kansas City, Medical Director of Laboratory, Labcorp, President, Member & Director, Pathology Ventures, LLC
CAP TODAY does not endorse any of the products or services named within. This program is intended for US healthcare professionals. This program is being sponsored by 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
Wednesday, November 18, 2026, 12:00 PM-1 PM ET
Join leading pathology experts, Savitri Krishnamurthy, MD, and Marilyn Bui, MD, PhD, for a webinar exploring potential challenges in HER2 IHC testing for breast cancer, emerging evidence supporting digital and computational pathology as assistive tools for pathologists in HER2 IHC assessment, and practical considerations for real-world implementation and adoption.
Webinar presenters Savitri Krishnamurthy, MD, Professor of Pathology, Department of Anatomical Pathology The University of Texas MD Anderson Cancer Center, Houston, Texas, and Marilyn Bui, MD, PhD, Surgical Pathologist and Cytopathologist Member and Professor, Departments of Pathology, Machine Learning, and Translational Pathology, Scientific Director, Analytic Microscopy Core Chair, Women in Oncology Executive Board Moffitt Cancer Center, Tampa, Florida
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 speakers are being compensated for their presentations. The program is not CME accredited and may not be used for CME credit.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Wednesday, December 9, 2026, 12 PM-1 PM ET
Hear an expert pathologist discuss the role of HER2 IHC testing and scoring in solid tumors including endometrial, ovarian, cervical, bladder, non-small cell lung, colorectal, and biliary cancers
Webinar presenter Michelle Shiller, DO, MSPT, Baylor Sammons Cancer Center; Fulgent Genetics; Texas Cancer Interception Institute
CAP TODAY does not endorse any of the products or services named within. This program is intended for US healthcare professionals. This program is being sponsored by 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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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.