Roche's AI-Powered Lung Cancer Diagnostic Receives FDA Breakthrough Designation

Roche has secured a breakthrough designation from the U.S. Food and Drug Administration (FDA) for its innovative cancer test that combines antibody assay technology with artificial intelligence-driven analysis. This computational pathology system, known as the Ventana TROP2 RxDx Device, could become the first AI-driven companion diagnostic for non-small cell lung cancer (NSCLC) approved by the FDA.

Revolutionary Diagnostic Technology

The Ventana TROP2 RxDx Device incorporates several advanced components, including an immunohistochemistry staining kit and instrument, digital pathology scanners, an image management platform, and an AI algorithm. This integrated system processes whole-slide images of NSCLC tissue to generate a quantitative TROP2 score, offering a level of precision that surpasses traditional manual methods.

A key feature of the diagnostic is its ability to measure the ratio of TROP2 protein expression on the membranes of tumor cells versus within their cytoplasm. This normalized membrane ratio score, dubbed QCS-NMR, allows for the classification of non-squamous NSCLC patients as either positive or negative based on a predefined cutoff level.

Companion Diagnostic for Datroway

Roche's test is designed to identify patients with advanced or metastatic NSCLC who may benefit from treatment with Datroway (datopotamab deruxtecan-dlnk), an antibody-drug conjugate (ADC) developed by AstraZeneca and Daiichi Sankyo. Datroway received its first U.S. approval in January for HR-positive, HER2-negative breast cancer and is currently under priority review by the FDA for EGFR-mutated NSCLC, with a decision expected in mid-July.

The development of this companion diagnostic follows a setback in Datroway's phase 3 trial for NSCLC last year, where it failed to meet its overall survival improvement target. In response, AstraZeneca and Daiichi Sankyo pursued an AI-powered diagnostic strategy after a retrospective analysis revealed varying efficacy among patient subgroups. The Ventana TROP2 assay incorporates AstraZeneca's proprietary algorithm platform, known as quantitative continuous scoring (QCS).

Market Impact and Future Prospects

While Datroway has shown promise in breast cancer treatment, collecting approximately $10 million in sales through the end of March in the U.S. and Japan, its potential in the NSCLC market remains a key focus for AstraZeneca and Daiichi Sankyo. Analysts have described the EGFR-mutated NSCLC indication as potentially the larger market opportunity for the drug.

The breakthrough designation for Roche's companion diagnostic underscores the growing importance of AI-driven technologies in oncology and personalized medicine. As the pharmaceutical industry continues to develop targeted therapies like ADCs, the role of advanced diagnostics in identifying suitable patients and optimizing treatment outcomes is likely to expand further.