Posted by Michael Wonder on 30 Apr 2025
Roche granted FDA breakthrough device designation for first AI-driven companion diagnostic for non-small cell lung cancer
29 April 2025 - The VENTANA TROP2 (EPR20043) RxDx device is an immunohistochemistry assay combined with a digital pathology algorithm to determine patient treatment.
Roche announced today that the US FDA granted breakthrough device designation for the VENTANA TROP2 (EPR20043) RxDx device. This is the first breakthrough device designation to be granted for a computational pathology companion diagnostic device.
