Roche Receives FDA Breakthrough Device Designation for AI-Driven Lung Cancer Diagnostic
SHERIDAN, WYOMING – May 8, 2025 – Roche has achieved a significant milestone in oncology diagnostics with the U.S. Food and Drug Administration (FDA) granting Breakthrough Device Designation for its VENTANA® TROP2 (EPR20043) RxDx Device. This marks the first FDA recognition for a computational pathology companion diagnostic (CDx) device using artificial intelligence, highlighting Roche's continued leadership in cancer diagnostics and precision medicine.
The innovative VENTANA TROP2 RxDx device leverages AI to enhance diagnostic precision, improving the detection of non-small cell lung cancer (NSCLC) and enabling personalized treatment decisions. By utilizing cutting-edge digital pathology and AI-driven algorithms, Roche is setting a new standard for oncological diagnostics, advancing both the accuracy and speed of patient treatment strategies.