Roche (SWX: ROG), based in Switzerland, has received CE marking from the European Commission (EC) for a new indication of its antibody-based test, Ventana HER2 (4B5). This test serves as a companion diagnostic to identify breast cancer patients eligible for AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo’s (TYO: 4568) antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan), even in cases of low HER2 expression. The upgraded test can now quantify HER2 levels in tumor tissue samples, potentially expanding the market for the HER2-targeted drug by accurately identifying patients who may have been misclassified as HER2-negative due to low protein expression.
This distinction enables Roche to commercialize the test across the European Economic Area.- Flcube.com
