Roche granted FDA BDD for VENTANA TROP2 RxDx Device

Roche (RHHBY) announced that the U.S. Food and Drug Administration, FDA, granted Breakthrough Device Designation for the VENTANA TROP2 RxDx Device. This is the first Breakthrough Device Designation, BDD, to be granted for a computational pathology companion diagnostic, CDx, device. The VENTANA TROP2 RxDx Device is a computational pathology device, consisting of the TROP2 algorithm, navify Digital Pathology Image Management System, Roche Digital Pathology scanners and the VENTANA TROP2 RxDx Assay used with OptiView DAB Detection Kit for staining on a BenchMark ULTRA IHC/ISH staining instrument. The VENTANA TROP2 RxDx Device analyses whole slide images of non-small cell lung cancer tissue stained with TROP2 to compute a quantitative TROP2 score.