AI Pathology Breakthrough: Roche’s Lung Cancer Diagnostic Makes FDA History
In April 2025, Roche’s Ventana TROP2 (EPR20043) RxDx test became the first AI-powered diagnostic to receive FDA Breakthrough Device Designation. The device pairs an immunohistochemistry stain for TROP2 with a digital pathology AI algorithm that runs in Roche’s Navify system to analyze NSCLC biopsy slides. The AI calculates a Normalized Membrane Ratio (NMR), the ratio of surface TROP2 to internal TROP2, to classify tumors as TROP2-positive or -negative. The Ventana TROP2 RxDx is a full diagnostic system, including Roche’s slide scanners, the Navify image management software, the Ventana TROP2 IHC kit, and the AI algorithm. A positive NMR score thresholds