Companion Diagnostics

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Roche granted FDA Breakthrough Device Designation for first AI-driven companion diagnostic for non-small cell lung cancer
Globenewswire· 2025-04-29 13:00
The VENTANA TROP2 (EPR20043) RxDx Device is an immunohistochemistry (IHC) assay combined with a digital pathology algorithm to determine patient treatment. The device uses artificial intelligence-based image analysis with a level of diagnostic precision not possible with traditional manual scoring methods. This Breakthrough Device Designation (BDD) demonstrates Roche’s continued innovation in companion diagnostics and digital pathology to enable more precise diagnosis in oncology. Basel, 29 April 2025 - Roc ...