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Roche granted FDA Breakthrough Device Designation for first AI-driven companion diagnostic for non-small cell lung cancer

Roche Diagnostics Schweiz AG

The VENTANA TROP2 (EPR20043) RxDx Device is an immunohistochemistry (IHC) assay combined with a digital pathology algorithm to determine patient treatment

2 May 2025

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Roche has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the VENTANA® TROP2 (EPR20043) RxDx Device. This is the first Breakthrough Device Designation to be granted for a computational pathology companion diagnostic (CDx) device.

The VENTANA TROP2 (EPR20043) RxDx Device is a computational pathology device, consisting of the TROP2 algorithm, navify® Digital Pathology Image Management System, Roche Digital Pathology scanners (DP 200, DP 600) and the VENTANA TROP2 (EPR20043) RxDx Assay used with OptiView DAB Detection Kit for staining on a BenchMark ULTRA IHC/ISH staining instrument.

The VENTANA TROP2 (EPR20043) RxDx Device analyses whole slide images of non-small cell lung cancer (NSCLC) tissue stained with TROP2 to compute a quantitative TROP2 score.

The algorithm incorporates AstraZeneca’s proprietary computational pathology platform, Quantitative Continuous Scoring (QCS), which enables a level of diagnostic precision not possible with traditional manual scoring methods.

The FDA granting Breakthrough Device Designation has the potential to make a TROP2 CDx AI-driven system available sooner, which could aid in identifying patients with NSCLC most likely to benefit from treatment with Daiichi Sankyo and AstraZeneca’s DATROWAY® (datopotamab deruxtecan-dlnk).

DATROWAY is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by AstraZeneca and Daiichi Sankyo.

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