By Fineline Cube 
Swiss giant Roche AG (SWX: ROG, OTCMKTS: RHHBY) announced that its VENTANA TROP2 (EPR20043) RxDx Device has been granted Breakthrough Device Designation (BDD) by the US Food and Drug Administration (FDA). This marks the first BDD status awarded to a computational pathology companion diagnostic (CDx) device.
Device Overview and Components
The VENTANA TROP2 (EPR20043) RxDx Device is a computational pathology tool that includes the TROP2 algorithm, the Navify Digital Pathology Image Management System, Roche Digital Pathology scanners (DP 200, DP 600), and the VENTANA TROP2 (EPR20043) RxDx Assay used with the OptiView DAB Detection Kit for staining on a BenchMark ULTRA IHC/ISH staining instrument. The device analyzes whole slide images of non-small cell lung cancer (NSCLC) tissue stained with TROP2 to compute a quantitative TROP2 score.
Significance of Breakthrough Designation
The FDA’s Breakthrough Device Designation has the potential to expedite the availability of a TROP2 CDx AI-driven system. This is expected to aid in identifying patients with NSCLC who are most likely to benefit from treatment with Daiichi Sankyo and AstraZeneca’s Datroway (datopotamab deruxtecan-dlnk).-Fineline Info & Tech