SHERIDAN, WYOMING – May 8, 2025 – Roche has achieved a significant milestone in oncology diagnostics with the U.S. Food and Drug Administration (FDA) granting Breakthrough Device Designation for its VENTANA® TROP2 (EPR20043) RxDx Device. This marks the first FDA recognition for a computational pathology companion diagnostic (CDx) device using artificial intelligence, highlighting Roche's continued leadership in cancer diagnostics and precision medicine.
The innovative VENTANA TROP2 RxDx device leverages AI to enhance diagnostic precision, improving the detection of non-small cell lung cancer (NSCLC) and enabling personalized treatment decisions. By utilizing cutting-edge digital pathology and AI-driven algorithms, Roche is setting a new standard for oncological diagnostics, advancing both the accuracy and speed of patient treatment strategies.
Revolutionizing Lung Cancer Diagnosis with AI
The VENTANA TROP2 (EPR20043) RxDx Device combines advanced immunohistochemistry (IHC) technology with an AI-powered digital pathology platform, offering a revolutionary approach to diagnosing NSCLC. The device uses a proprietary algorithm to analyze whole slide images of NSCLC tissue, specifically stained with the TROP2 biomarker, to compute a quantitative TROP2 score.
By incorporating AstraZeneca’s Quantitative Continuous Scoring (QCS) system, this breakthrough solution delivers an unprecedented level of diagnostic precision—far beyond the capabilities of traditional manual scoring methods. The result is a more accurate understanding of tumor characteristics, aiding pathologists in determining which patients are most likely to benefit from targeted treatments.
Strategic Impact on Personalized Cancer Treatment
“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.”
The VENTANA TROP2 device is designed to identify patients with previously treated advanced or metastatic non-squamous NSCLC without actionable genomic alterations (AGA), potentially benefiting from treatment with the DATROWAY® (datopotamab deruxtecan-dlnk) antibody drug conjugate. This collaboration between AstraZeneca and Daiichi Sankyo underscores the growing importance of computational pathology in enhancing therapeutic outcomes for cancer patients.
Breaking New Ground with Computational Pathology
The VENTANA TROP2 RxDx Device represents a paradigm shift in computational pathology, offering a sophisticated tool for pathologists to assess the TROP2 biomarker in cancer tissue. The device works by generating the Normalized Membrane Ratio (NMR) score, which classifies TROP2 status as positive or negative based on predefined thresholds. This objective measure of staining intensity in both the membrane and cytoplasm provides critical insights into a patient’s likelihood of responding to targeted therapies.
The device’s AI-powered algorithm can independently detect tumor cells and generate accurate results in a fraction of the time required by traditional manual methods, improving diagnostic efficiency and consistency. By automating and enhancing the diagnostic process, Roche is empowering healthcare providers to make faster, more informed treatment decisions, ultimately improving patient outcomes.
Industry-Leading Partnership and Future Impact
Roche’s breakthrough in AI-driven diagnostics is complemented by its longstanding collaboration with AstraZeneca. “This FDA Breakthrough Device Designation underscores the potential of our computational pathology platform to enable more personalized treatment decisions for people with cancer,” stated Susan Galbraith, Executive Vice President, Oncology Haematology R&D at AstraZeneca.
The approval of the VENTANA TROP2 RxDx device opens the door to faster and more effective deployment of the TROP2 AI system, potentially expediting patient access to innovative therapies. This advancement aligns with Roche’s commitment to transforming oncology diagnostics and reinforcing its position as a leader in personalized healthcare solutions.
About Roche
Founded in 1896, Roche is the world’s largest biotechnology company and a pioneer in personalized healthcare. Based in Basel, Switzerland, Roche is at the forefront of developing groundbreaking medicines and diagnostics. With a strong commitment to sustainability and innovation, Roche aims to revolutionize how healthcare is delivered, improving patient outcomes globally.
For more information, visit Roche’s official website.