FDA clears TruVerus multimodal blood testing instrument
Dec. 22, 2025—The FDA has granted 510(k) clearance for Truvian Health’s TruVerus multimodal blood testing benchtop instrument and a test panel focused on kidney health.
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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Industry News
Roche launches next-gen Cobas 6800/8800 systems, software
Dec. 18, 2025—Roche launched Cobas 6800/8800 systems version 2.0 and software version 2.0.1, following FDA 510(k) clearance earlier this year.
Thermo Fisher Scientific launches microarray solution
Dec. 17, 2025—Thermo Fisher Scientific has introduced the Applied Biosystems SwiftArrayStudio microarray analyzer, designed for fast and scalable sample analysis.
FDA approves new indications for Roche HER2 tests
Dec. 16, 2025—The Food and Drug Administration has approved additional indications for Roche’s Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody and Ventana HER2 Dual ISH DNA Probe Cocktail tests.
Werfen applauds call to address undetected hemolysis
Dec. 15, 2025—Werfen announced its commendation of the publication of a special report underscoring the urgent need to address the risks of undetected in vitro hemolysis (Wu AHB, et al. J Appl Lab Med. 2025;10[5]:1347–1361).
Natera acquires Foresight Dx
Dec. 12, 2025—Natera has completed a transaction to acquire cancer diagnostics company Foresight Diagnostics.
FDA qualifies AIM-MASH AI Assist for MASH clinical trials
Dec. 11, 2025—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.
Randox type 1 diabetes risk test gets CE mark
Dec. 8, 2025—Randox’s type 1 diabetes risk test has received CE marking.
Roche gets clearance, CLIA waiver for POC Bordetella test
Dec. 2, 2025—Roche’s Cobas Liat Bordetella test for the detection of Bordetella infections, including pertussis, has been granted FDA 510(k) clearance and a CLIA waiver.
CMS finalizes pricing determination for OncoReveal CDx
Dec. 1, 2025—The Centers for Medicare and Medicaid Services has finalized its pricing determination for Pillar Biosciences’ OncoReveal CDx.