Core Viewpoint - Roche has received FDA Breakthrough Device Designation for the VENTANA® TROP2 (EPR20043) RxDx Device, marking a significant advancement in computational pathology companion diagnostics for oncology [1][2]. Group 1: Product Details - The VENTANA TROP2 (EPR20043) RxDx Device utilizes artificial intelligence to enhance sample analysis, providing a quantitative TROP2 score for non-small cell lung cancer (NSCLC) tissue [2][8]. - The device integrates the TROP2 algorithm, navify® Digital Pathology Image Management System, and Roche Digital Pathology scanners, along with the VENTANA TROP2 RxDx Assay [2][5]. - It is specifically designed to identify patients with previously treated advanced or metastatic non-squamous NSCLC who are most likely to benefit from treatment with the DATROWAY® (datopotamab deruxtecan-dlnk) [5][8]. Group 2: Technological Innovation - The algorithm employs AstraZeneca's Quantitative Continuous Scoring (QCS) platform, which enhances diagnostic precision beyond traditional manual methods [3][6]. - The device's AI-driven image analysis allows for a more accurate assessment of TROP2 IHC staining intensity, leading to the computation of the Normalised Membrane Ratio (NMR) score [6][8]. Group 3: Market Implications - The Breakthrough Device Designation may expedite the availability of the TROP2 CDx AI-driven system, facilitating timely identification of NSCLC patients who could benefit from targeted therapies [4][8]. - This designation reflects Roche's ongoing commitment to innovation in companion diagnostics and digital pathology, aiming to improve precision in oncology diagnoses [2][8].