CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
April 15, 2024—Roche announced it obtained the CE mark for its Ventana HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx to identify metastatic breast cancer patients with low HER2 expression for whom Enhertu (trastuzumab deruxtecan) may be considered as a targeted treatment. Enhertu is a specifically engineered HER2-directed antibody drug conjugate jointly developed by Daiichi Sankyo and AstraZeneca. The test is branded Pathway in the United States and received FDA approval in October 2022. It runs on the company’s BenchMark IHC/ISH slide staining instrument.