FDA clears Roche Alzheimer’s disease CSF assays
Dec. 8, 2022—Roche announced FDA 510(k) clearance of its Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Phospho-Tau (181P) CSF (pTau181) assays.
Webinars and Sponsored Roundtables — Register Now
Thursday, May 28, 2026, 1:00–2:00 PM ET
This session is designed to improve understanding and application of recent updates to synoptic pathology reporting protocols such as the latest Reporting Template for Reporting Results of Biomarker Testing of Specimens from Patients with Carcinoma of the Breast. These changes reflect evolving clinical guidelines that directly influence diagnostic accuracy and treatment selection in breast cancer care.
Webinar presenters Thaer Khoury, MD, FCAP, Chair, Pathology and Laboratory Medicine, Roswell Park Comprehensive Cancer Cente, and Colin Murphy, CEO of mTuitive.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
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
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Interactive Product Guides
Roche
FDA approves Ventana CDx to ID patients eligible for Elahere
Nov. 17, 2022—Roche announced FDA approval of the Ventana FOLR1 (FOLR1-2.1) RxDx assay, the first immunohistochemistry companion diagnostic test to aid in identifying epithelial ovarian cancer patients who are eligible for targeted treatment with Elahere (mirvetuximab soravtansine-gynx).
Roche launches antibody to identify PRAME protein expression
Nov. 15, 2022—Roche has launched its Anti-PRAME (EPR20330) Rabbit Monoclonal Primary Antibody to identify PRAME protein expression in tissue samples from patients who are suspected of having melanoma.
Roche introduces Cobas 5800 system
Nov. 9, 2022—Roche announced plans for the U.S. launch of the Cobas 5800 system, a compact, fully-automated molecular instrument that aims to offer a flexible, PCR testing solution to help clinicians diagnose infectious diseases.
FDA clears COVID-19 PCR test on Cobas 6800/8800 systems
Oct. 25, 2022—Roche announced that the FDA has granted 510(k) clearance for the Cobas SARS-CoV-2 Qualitative PCR test for use on the automated Cobas 6800 and Cobas 8800 systems.
Roche launches digital PCR system
October 2022—Roche launched its Digital LightCycler system, the company’s first digital polymerase chain reaction system, for precise DNA and RNA analysis in areas such as oncology and infectious diseases. The instrument features three unique reaction plates, six channel multiplexing capabilities, and a 5× concentrated master mix reagent. Run time is two to four hours with up to 96 samples per run.
Roche CDx approved to ID patients eligible for Enhertu
Oct. 5, 2022—Roche announced that the FDA has approved the Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody to identify patients with HER2-low metastatic breast cancer for whom Enhertu (fam-trastuzumab deruxtecan-nxki) may be considered as a targeted treatment. Enhertu is a specifically engineered HER2-directed antibody drug conjugate developed and commercialized by AstraZeneca and Daiichi Sankyo.
FDA clears Roche Cobas Pure for low- to mid-vol labs
Sept. 19, 2022—Roche received FDA 510(k) clearance for the Cobas Pure, a compact and modular solution that combines clinical chemistry, immunoassay, and ion-selective electrode diagnostic testing on a single platform with a footprint of about 21 square feet.
Roche receives EUA for Cobas SARS-CoV-2 Duo
September 2022—Roche announced that the FDA issued emergency use authorization for the Cobas SARS-CoV-2 Duo for use on the fully automated Cobas 6800/8800 systems. The real-time RT-PCR assay is for the in vitro qualitative and quantitative detection of SARS-CoV-2 RNA in nasal and nasopharyngeal swab specimens. The assay also performs quantitation of SARS-CoV-2 RNA levels in the collected specimen; however, only the qualitative result of the assay is intended for use as an aid in diagnosing SARS-CoV-2 infection in patients suspected of COVID-19 by their health care provider.
Roche COVID-19 test detects, differentiates BA.2.75
September 2022—Roche and its subsidiary TIB Molbiol have developed a COVID-19 test that detects and differentiates the BA.2.75 subvariant. The VirSNiP SARS-CoV-2 Spike 147E 152R test, for research use only, targets two of the known unique mutations, K147E and W152R, in BA.2.75, which allows clear differentiation against other notable subvariants. The test is for use on the Lightcycler and Cobas z480 instruments and is available worldwide.