Illumina Inc. (NASDAQ:ILMN) ranks among the top NASDAQ stocks with low P/E ratios. On September 23, Illumina Inc. (NASDAQ:ILMN) announced that it would collaborate with several global pharmaceutical companies to create companion diagnostics (CDx) for KRAS biomarkers on its TruSight Oncology Comprehensive genomic profiling test. The collaborations are intended to increase tumor-agnostic CDx claims for KRAS mutations, which are known to result in uncontrolled cell growth that can lead to cancer. By identif ...

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].