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.
Webinars and Sponsored Roundtables — Register Now
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
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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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.
Bio-Rad launches enhanced Liquichek opiate control
December 2025—Bio-Rad Laboratories has launched an enhanced version of its Liquichek opiate control. This version includes updated fentanyl target levels optimized for clinically relevant cutoffs across major chemistry platforms. It contains eight opioid drugs or drug metabolites at concentrations above and below assay cutoffs as recommended by the U.S. Substance Abuse and Mental Health Services Administration, other agencies, and reagent manufacturers.
OGT launches SureSeq Myeloid MRD Plus NGS panel
December 2025—OGT launched the SureSeq Myeloid MRD Plus NGS panel, to detect ultra-low frequency variants in key measurable residual disease–associated biomarkers in acute myeloid leukemia. The panel targets 16 biomarkers associated with AML, including NPM1 and large FLT3 internal tandem duplications, and detects variants at allele frequencies as low as 0.01 percent.