Roche Earns FDA Breakthrough Designation For First AI-Based TROP2 Diagnostic Device In Lung Cancer

Roche has received Breakthrough Device Designation from the U.S. FDA for its VENTANA® TROP2 (EPR20043) RxDx Device, marking the first time a computational pathology companion diagnostic has earned this status. The designation could accelerate access to the AI-driven diagnostic system for non-small cell lung cancer (NSCLC) patients.

“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 personalised treatment.”

The VENTANA TROP2 RxDx Device integrates several Roche technologies, including the TROP2 algorithm, digital pathology scanners, and staining systems, to analyse TROP2 expression in NSCLC tissue samples. It produces a quantitative TROP2 score using whole slide imaging and advanced AI. The diagnostic tool incorporates AstraZeneca’s Quantitative Continuous Scoring (QCS) platform, which enhances precision beyond conventional methods.

“This FDA Breakthrough Device Designation underscores the potential of our computational pathology platform to enable more personalised treatment decisions for people with cancer,” said Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca.

This breakthrough device could play a crucial role in identifying NSCLC patients likely to benefit from DATROWAY® (datopotamab deruxtecan-dlnk), a TROP2-targeted antibody drug conjugate developed by Daiichi Sankyo and AstraZeneca.