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Roche has achieved CE Mark approval for the VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx, a companion diagnostic designed to identify metastatic breast cancer patients expressing low levels of HER2. This approval enables the consideration of ENHERTU (trastuzumab deruxtecan) as a targeted treatment for these patients.

Metastatic breast cancer (mBC) affects a significant portion of patients, with approximately half expressing low levels of HER2. Traditionally, patients with low HER2 expression were classified as HER2-negative and excluded from HER2-targeted treatments. However, the availability of the VENTANA HER2 (4B5) test now provides a method to identify patients with low HER2 status, potentially expanding treatment options.

The VENTANA HER2 (4B5) test, branded as PATHWAY in the United States, received approval from the US Food and Drug Administration (FDA) in October 2022. This diagnostic tool aids in assessing HER2-low status in metastatic breast cancer patients, facilitating more targeted treatment approaches.

“We are proud to continue our innovation in breast cancer diagnostics through critical tests like this one, which helps identify patients with HER2-low status,” said Jill German, Head of Pathology Lab at Roche Diagnostics. “With this expanded approval of our test, we’re pleased that more metastatic breast cancer patients across the world may be correctly identified and potentially eligible for this targeted therapy.”

The VENTANA HER2 (4B5) test incorporates a scoring algorithm to identify “low expressors” of HER2, enabling the designation of HER2 low status for these patients. This expansion of the test’s approval enhances its utility in identifying patients who may benefit from ENHERTU treatment.

Breast cancer remains a significant global health concern, with millions of new cases diagnosed annually. The approval of the VENTANA HER2 (4B5) test for HER2-low indication underscores Roche’s commitment to advancing personalized healthcare through innovative diagnostics. The VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx, used in conjunction with the BenchMark IHC/ISH slide staining instrument, offers standardization and reliability in immunohistochemistry processes. This pre-diluted antibody minimizes variability and enhances proficiency assessment in HER2 expression testing.

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