Roche gets CE mark for Cobas Mass Spec solution
Dec. 20, 2024—Roche announced it has received CE mark approval for its Cobas Mass Spec solution, including the Cobas i 601 analyzer and Ionify reagent pack of four assays for steroid hormones.
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
Subspecialties
Interactive Product Guides
Roche
FDA approves Roche CDx for biliary tract cancer
December 2024—Roche announced FDA approval of a label expansion into biliary tract cancer for the Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, a companion diagnostic to aid in the assessment of HER2-positive status to identify patients with biliary tract cancer who are eligible for treatment with zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals). Ziihera is an FDA-approved treatment for adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer. The Pathway HER2 (4B5) test is used in combination with the Ventana BenchMark slide staining instrument.
Newsbytes
October 2024—Conducting informal pathology clinics in his office to help patients better understand their diagnosis has been standard fare for John Groth, MD. But this will change in the coming months as he finishes setting up a formal clinic, replete with the technology and tools necessary to more easily educate patients at Endeavor Health’s Evanston Hospital.
Roche launches Cobas Respiratory flex test
October 2024—Roche announced the launch of the Cobas Respiratory flex test, the first to use Roche’s novel and proprietary TAGS (temperature-activated generation of signal) technology. Developed by Roche scientists, TAGS technology uses multiplex PCR testing combined with color, temperature, and data processing to identify as many as 15 pathogens in a single PCR test. The Respiratory flex test can detect up to 12 of the most common respiratory viruses, including influenza A and B, respiratory syncytial virus, and SARS-CoV-2. The test runs on the high-throughput Cobas 5800, 6800, and 8800 analyzers.
Roche launches ISH test for B-cell lymphoma
August 2024—Roche has launched the Ventana Kappa and Lambda Dual ISH mRNA Probe Cocktail assay in countries accepting the CE mark. The assay is intended for the qualitative detection of kappa and lambda mRNA in formalin-fixed, paraffin-embedded human bone marrow and lymphoid tissue stained on a BenchMark IHC/ISH instrument using chromogenic in situ hybridization and visualized using light microscopy. The test is intended as an aid in the identification of B-cell lymphomas and plasma cell neoplasms. The results of the assay should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. The product is intended for in vitro diagnostic use.
Roche gets breakthrough device designation for Lp(a) assay
July 2024—Roche announced that the Tina-quant lipoprotein Lp(a) RxDx assay, developed in collaboration with Amgen, has received breakthrough device designation from the FDA. The assay measures lipoprotein (a) in a person’s bloodstream and is for use in identifying patients who may benefit from Lp(a)-lowering therapy now in development. If approved, the assay will be available on select Cobas platforms.
FDA clears Roche digital pathology solution for diagnostic use
June 18, 2024—Roche announced that its whole slide imaging system, the Roche Digital Pathology Dx, has received FDA 510(k) clearance.
Newsbytes
June 2024—Fairness, like so many principles, is subjective. Yet that is not deterring a growing number of medical informaticists and others interested in health care technology from advocating to incorporate fairness into machine learning algorithms to combat bias.
Roche gets breakthrough device designation for Lp(a) assay
May 22, 2024—Roche announced that the Tina-quant lipoprotein Lp(a) RxDx assay, developed in collaboration with Amgen, has received breakthrough device designation from the FDA.
Roche gets approval for HPV self-collection solution
May 15, 2024—The FDA has approved Roche’s HPV self-collection solution for use with the company’s Cobas HPV test.