April 29, 2025—Roche announced that the FDA granted breakthrough device designation for the Ventana TROP2 (EPR20043) RxDx device, a computational pathology device. It consists of the TROP2 algorithm, Navify digital pathology image management system, Roche digital pathology scanners (DP 200, DP 600), and Ventana TROP2 (EPR20043) RxDx assay used with the OptiView DAB detection kit for staining on a BenchMark Ultra IHC/ISH staining instrument. The device analyzes whole slide images of non-small cell lung cancer tissue stained with TROP2 to compute a quantitative TROP2 score. The algorithm incorporates AstraZeneca’s proprietary computational pathology platform, Quantitative Continuous Scoring.
The device is indicated as an aid in identifying patients with previously treated advanced or metastatic nonsquamous NSCLC without actionable genomic alteration most likely to benefit from treatment with Daiichi Sanko and AstraZeneca’s Datroway (datopotamab deruxtecan-dlnk).
Roche reports that this is the first breakthrough device designation to be granted for a computational pathology companion diagnostic device.