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-powered image analysis for precise TROP2 scoring, surpassing traditional manual methods. It combines an IHC assay with a digital pathology algorithm to aid in identifying NSCLC patients who would benefit from DATROWAY treatment. AstraZeneca's Quantitative Continuous Scoring (QCS) platform is integrated into the algorithm. The device helps personalize treatment by accurately identifying suitable candidates for the targeted therapy. This designation could expedite the device's availability, benefiting patients with advanced or metastatic NSCLC. Roche highlights its commitment to innovative oncology diagnostics through this development. The device requires pathologist review for quality assurance and adequate tumor detection. The final TROP2 status is determined by a normalized membrane ratio (NMR) score.