Roche’s AI-Driven CDx for Non-Small Cell Lung Cancer Earns FDA Breakthrough Status

Roche has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Ventana TROP2 (EPR20043) RxDx device. According to the company, this is the first breakthrough nod granted for a computational pathology companion diagnostic (CDx) device.

The computational pathology device consists of the TROP2 algorithm, navify digital pathology image management system, Roche digital pathology scanners (DP 200 and DP 600) and the Ventana TROP2 RxDx assay used with OptiView DAB detection kit for staining on a BenchMark Ultra IHC/ISH staining instrument.

Ventana TROP2 RxDx analyzes whole slide images of non-small cell lung cancer (NSCLC) tissue stained with TROP2 to generate a quantitative TROP2 score. The algorithm leverages AstraZeneca’s Quantitative Continuous Scoring (QCS) computational pathology platform, which allows diagnostic precision that’s purportedly impossible with traditional manual scoring methods.

Breakthrough device status for a TROP2 CDx AI-driven system could help identify patients with NSCLC that are 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 is being jointly developed by AstraZeneca and Daiichi Sankyo.

“This FDA Breakthrough Device Designation is another example of our commitment to deliver innovation that enables more precise diagnosis in oncology,” said Matt Sause, CEO of Roche Diagnostics. “This solution, which leverages our industry-leading expertise in companion diagnostics development, uses artificial intelligence for a greater depth of sample analysis, helping to deliver truly personalized treatment.”

In January 2025, the company announced it had won FDA clearance for its Lipoprotein (a) Gen.2 Molarity assay, the first 510(k)-cleared test of its kind in the U.S. to measure lipoprotein (a), or Lp(a), in nanomoles per liter (nmol/L).