Roche gets FDA approval for HPV test on Cobas 5800 system
Nov. 6, 2023—Roche announced that the FDA has approved the Cobas HPV test for use on its next-generation Cobas 5800 molecular instrument.
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 clears Roche tTau/Abeta42 Alzheimer’s assays
June 28, 2023—Roche announced that its Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Total-Tau CSF (tTau) assays have received FDA 510(k) clearance and will be available in Q4 2023.
FDA expands approval for Ventana PD-L1 assay
May 2023—Roche announced FDA approval of the Ventana PD-L1 (SP263) assay as a companion diagnostic to identify patients with locally advanced and metastatic non-small cell lung cancer eligible for treatment with Libtayo (cemiplimab-rwlc), a PD-1 inhibitor therapy developed by Regeneron. Libtayo’s approval is based on results of the phase three EMPOWER-Lung 1 study. The OptiView DAB IHC detection kit is used for staining on a BenchMark Ultra instrument.
Roche, Eli Lilly to develop Elecsys Amyloid Plasma Panel for Alzheimer’s
March 22, 2023—Roche has entered into a collaboration with Eli Lilly to support the development of Roche’s Elecsys Amyloid Plasma Panel.
FDA expands approval for Ventana PD-L1 (SP263) assay
March 13, 2023—Roche announced that the FDA has approved the Ventana PD-L1 (SP263) assay as a companion diagnostic to identify non-small cell lung cancer patients eligible for treatment with Libtayo, a PD-1 inhibitor therapy developed by Regeneron.
Roche launches antibody to identify PRAME protein expression
January 2023—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. Studies suggest that the detection of PRAME expression by immunohistochemistry complements findings from routinely used tests and enables more informed clinical decisions and improved patient outcomes, according to a company press release.
Roche launches antibodies to ID mutations in brain cancer
Feb. 27, 2023—Roche launched the IDH1 R132H (MRQ-67) Rabbit Monoclonal Primary Antibody and ATRX Rabbit Polyclonal Antibody to identify mutation status in patients who have brain cancer.
Roche gets EUA for high-throughput monkeypox test
December 2022—Roche announced that the FDA has granted emergency use authorization for the Cobas MPXV for use on Cobas 6800/8800 systems. The real-time PCR test is for the qualitative detection of DNA from monkeypox virus in lesion swabs collected from individuals suspected of having monkeypox infection by their health care provider. The assay uses β-globin as an endogenous control to assess specimen adequacy. It detects monkeypox nucleic acids and the endogenous control in the same well.
Roche introduces Cobas 5800 to expand access to PCR testing in the U.S.
December 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
November 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. It is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in nasal and nasopharyngeal swab specimens collected from symptomatic patients who are suspected of having COVID-19 by their health care provider. The single-well, dual-target assay includes specific detection of SARS-CoV-2 and pan-sarbecovirus detection for the sarbecovirus subgenus that includes SARS-CoV-2.