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Roche’s Companion Diagnostic for Enhertu in Breast Cancer Granted CE Mark

NextEdge Admin

10 Apr 2024

1 min 51 sec

Roche recently disclosed that its companion diagnostic test, designed to ascertain breast cancer patients suitable for Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) treatment, has been awarded CE marking. Known as Ventana HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx, marketed as Pathway in the US, this test aims to identify metastatic breast cancer patients with low HER2 expression, indicating potential eligibility for Enhertu therapy, as per Roche’s statement.

The updated test now features a scoring algorithm aiding pathologists in pinpointing low HER2 expressors. This modification in the cutoff facilitates the assay in identifying patients potentially benefiting from Enhertu. Roche specified that the pre-diluted assay is compatible with the BenchMark IHC/ISH slide staining instrument, streamlining immunohistochemistry procedures.

Enhertu, an engineered HER2-directed antibody drug conjugate, is a joint effort between Daiichi Sankyo and AstraZeneca, aiming at targeted treatment for breast cancer.

The CE mark for the HER2-low indication broadens the intended application of the Ventana HER2 assay, which secured approval from the US Food and Drug Administration in 2022. This expansion signifies a step forward in tailoring treatments for breast cancer patients, enhancing the precision and efficacy of therapeutic interventions.