"The VENTANA TROP2 (EPR20043) RxDx Device is an immunohistochemistry (IHC) assay combined with a digital pathology algorithm to determine patient treatment; The device uses artificial intelligence-based image analysis with a level of diagnostic precision not possible with traditional manual scoring methods; This Breakthrough Device Designation (BDD) demonstrates Roche’s continued innovation in companion diagnostics and digital pathology to enable more precise diagnosis in oncology."