Roche granted FDA Breakthrough Device Designation for first AI-driven companion diagnostic for non-small cell lung cancer

The FDA granted Breakthrough Device Designation to Roche's VENTANA TROP2 (EPR20043) RxDx Device, a computational pathology device for non-small cell lung cancer (NSCLC). This is the first such designation for a computational pathology companion diagnostic. The device uses AI-based image analysis for more precise diagnosis than traditional methods. It combines an immunohistochemistry assay with a digital pathology algorithm to determine TROP2 status. This helps identify NSCLC patients likely to benefit from DATROWAY treatment. The device incorporates AstraZeneca's Quantitative Continuous Scoring (QCS) platform. Roche's innovation in companion diagnostics and digital pathology led to this designation. Faster availability of the AI-driven system is expected. The device aids in personalized treatment decisions for cancer patients. A qualified pathologist reviews the results.