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. These tests are now approved to aid in identifying patients with HER2-positive metastatic breast cancer who may be eligible for treatment with Enhertu (trastuzumab deruxtecan). The Pathway HER2 (4B5) test is also approved for identifying metastatic breast cancer patients with HER2-low and HER2-ultralow expression.
The Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody is used in combination with the BenchMark Ultra and BenchMark Ultra Plus staining platforms. The Ventana HER2 Dual ISH DNA Probe Cocktail assay is for use with the Ventana Silver ISH DNP Detection kit and Red ISH DIG Detection kit on the BenchMark Ultra and Ultra Plus.