Roche to acquire PathAI for up to $1 billion
May 7, 2026—Roche has entered into a definitive merger agreement to acquire PathAI, extending a partnership that began in 2021 and expanded in 2024 to develop AI-based companion diagnostic algorithms.
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 Cobas c 703, Cobas ISE Neo
March 31, 2026—The Food and Drug Administration granted 510(k) clearance to Roche’s Cobas c 703 and Cobas ISE Neo analytical units.
Roche mass spec steroid assays categorized as moderate complexity
March 18, 2026—Roche received CLIA moderate complexity categorization for its Ionify steroid assays for mass spectrometry.
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.
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.
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.
FDA clears Roche’s Elecsys pTau181 blood test
Oct. 16, 2025—The FDA has cleared Roche’s Elecsys pTau181 test, a blood-based biomarker test indicated as an aid in the initial assessment for Alzheimer’s disease and other causes of cognitive decline in the primary care setting.
Roche receives CE mark for Elecsys pTau181
September 2025—Roche has received the CE mark for its Elecsys pTau181 test to measure phosphorylated tau 181 protein, an indicator of amyloid pathology. The test, developed in collaboration with Eli Lilly, can be used by clinicians in conjunction with other clinical information to rule out Alzheimer’s disease as the cause of cognitive decline.
The CE mark for the test was based on data from a prospective, multicenter study that included 787 patients in the United States, Europe, and Australia. The study showed the test was able to rule out Alzheimer’s disease with a high negative predictive value of 93.8 percent, based on a 22.5 percent prevalence of amyloid positivity according to PET scans, and with 83.6 percent sensitivity.
Roche gets clearance for Cobas Respiratory 4-flex
Aug. 4, 2025—Roche announced FDA 510(k) clearance for its Cobas Respiratory 4-flex assay.
Roche receives CE mark for Elecsys pTau181
July 28, 2025—Roche has received the CE mark for its Elecsys pTau181 test to measure phosphorylated tau 181 protein, an indicator of amyloid pathology.