Roche Receives FDA Breakthrough Device Designation for AI-Driven Companion Diagnostic for Non-Small Cell Lung Cancer

Roche has been granted FDA Breakthrough Device Designation for the VENTANA® TROP2 (EPR20043) RxDx Device, marking a significant milestone in the field of computational pathology for non-small cell lung cancer (NSCLC). On April 29, 2025, Roche (SIX: RO, ROG; OTCQX: RHHBY) announced the receipt of this designation from the U.S. Food and Drug Administration (FDA). The VENTANA TROP2 (EPR20043) RxDx Device is the first AI-driven companion diagnostic to receive such recognition. "This FDA Breakthrough Device Designation is a testament to our ongoing commitment to delivering precise diagnostic tools for oncology," stated Matt Sause, CEO of Roche Diagnostics. "By leveraging our expertise in companion diagnostics and artificial intelligence, we can offer a deeper analysis of samples, enabling truly personalized treatment options." The VENTANA TROP2 (EPR20043) RxDx Device integrates several components: the TROP2 algorithm, the navify® Digital Pathology Image Management System, Roche Digital Pathology scanners (DP 200 and DP 600), and the VENTANA TROP2 (EPR20043) RxDx Assay with the OptiView DAB Detection Kit. This comprehensive system stains NSCLC tissue samples with TROP2 and then analyzes whole-slide images to compute a quantitative TROP2 score, which helps identify patients who may benefit from specific treatments. AstraZeneca's proprietary computational pathology platform, Quantitative Continuous Scoring (QCS), plays a crucial role in this device. QCS significantly enhances diagnostic precision compared to traditional manual scoring methods. "The FDA Breakthrough Device Designation is a strong endorsement of our computational pathology platform," said Susan Galbraith, Executive Vice President of Oncology Haematology R&D at AstraZeneca. "It brings us closer to making more personalized treatment decisions for cancer patients." The Breakthrough Device Designation from the FDA can expedite the development and review process for the VENTANA TROP2 (EPR20043) RxDx Device. This accelerated pathway aims to bring the device to market faster, where it can assist in identifying patients with previously treated advanced or metastatic non-squamous NSCLC without actionable genomic alterations (AGAs) who are most likely to benefit from treatment with DATROWAY® (datopotamab deruxtecan-dlnk). DATROWAY is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) developed through a collaboration between Daiichi Sankyo and AstraZeneca. Initially discovered by Daiichi Sankyo, this treatment targets TROP2, a protein expressed in many types of cancer cells, and delivers a potent anticancer drug directly to those cells. The identification of eligible patients with the aid of the VENTANA TROP2 (EPR20043) RxDx Device is critical for optimizing the effectiveness of DATROWAY. In more technical terms, the VENTANA TROP2 (EPR20043) RxDx Device aids in identifying patients with previously treated advanced or metastatic non-squamous NSCLC who lack actionable genomic alterations. Pathologists play a vital role in using this device, as they are responsible for evaluating staining and image quality and ensuring the tumor detection sensitivity and precision are adequate. These assessments are made in conjunction with histological examination, relevant clinical data, and appropriate controls. Roche, a leader in healthcare innovation, has been driving advancements in medicine and diagnostics for over 125 years. The company's commitment to sustainability is evident through its participation in initiatives like the Science Based Targets and the Sustainable Markets Initiative, aiming for net zero emissions by 2045. Roche's U.S. subsidiary, Genentech, and its majority stake in Chugai Pharmaceutical in Japan further highlight its global reach and influence in the healthcare sector. For additional information, visit www.roche.com. Roche Investor Relations Investor Relations North America