Roche’s Ventana HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx has received the CE mark to identify metastatic breast cancer patients associated with low HER2 expression eligible for Enhertu. The US FDA approved the test in Oct 2022 under the brand name, PATHWAY
The Ventana HER2 (4B5) test works on a scoring algorithm that detects the patient population with less HER2 expression and grants them a HER2 low-status
The test is combined with the automated BenchMark IHC/ISH slide staining instrument to minimize errors. Additionally, it was utilized in the DESTINY-Breast04 program to diagnose breast cancer patients with low HER2 (IHC 1+ or IHC 2+/ISH-) eligible for Enhertu, leading to the product’s approval
Ref: PR Newswire | Image: Roche
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