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, July 21, 2026, 11:00-11:30 AM CT
Learning Objectives:
- Explain how transparency and manufacturer partnerships improve quality, consistency, and decision-making confidence in specimen management.
- Evaluate blood collection tubes beyond cost and commodity assumptions, incorporating clinical impact and risk into decision-making.
- Assess the potential risk points when using a blood collection device that has not been cleared for a specific purpose.
Roundtable presenters Nick Fingland, PhD, PMP, Senior Director, R&D Operations and Science, BD, and Chris Farnsworth, PhD, D(ABCC), Section Head of Clinical Chemistry, Professor of Pathology and Immunology, Washington University School of Medicine.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Wednesday, July 29, 2026, 1:00-2:00 PM ET
Learn about digital pathology technology that is future-ready, yet practical for today’s
laboratory needs.
Webinar presenters Scott Hammond, Senior Systems Consultant, Digital Pathology Division, Wexner Medical Center, Department of Pathology, and Ursula Hofer, Imaging Technologist, Pathology Digital Imaging Lab, Wexner Medical Center, Department of Pathology, and Sandra Banky, PA(ASCP), Director of Operations, Wexner Medical Center, Department of Pathology.
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.