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, June 9, 2026, 1:00–2:00 PM ET
In this webinar, we will examine how immune recognition after allogeneic HCT can influence leukemia relapse and disease progression. The session will highlight the clinical relevance of HLA loss of heterozygosity (LOH), approaches used for its detection, and how LOH findings may support transplant strategies, including considerations for donor selection in subsequent transplantation.
Webinar presenter Alberto Cardoso Martins Lima, PhD, Clinical consulting scientist in histocompatibility,
specializing in allogeneic hematopoietic cell transplantation (HCT) at IGEN/AFIP São Paulo and CHC/UFPR in Curitiba, Brazil
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Wednesday, June 24, 2026, 12:00–1:00 PM ET
Hear an expert discuss the expanded clinical utility of HER2 IHC scoring in metastatic breast cancer and its impact on your practice
Webinar presenter Michelle Shiller, DO, AP, CP, MGP, FACP, Baylor University Medical Center.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Wednesday, July 15, 2026, 1:00-2:00 PM ET
Hear an expert discuss how to integrate Kappa and Lambda in situ hybridization testing into your standard hematopathology workflow to accurately assess B-cell and plasma cell clonality. You will also gain the skills to recognize testing pitfalls in challenging reactive versus neoplastic proliferations and apply ancillary tools to resolve complex cases.
Webinar presenter Xiaojun Wu, MD, PhD, Assistant professor, Director of Hematopathology Section at NCR of Johns Hopkins Medicine Department of Pathology, SOM at Johns Hopkins University
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.