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…
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