GRAIL Announces Positive Top-Line Results From The Galleri® PATHFINDER 2 Registrational Study

Core Insights - GRAIL, Inc. announced positive top-line performance and safety results from the PATHFINDER 2 study, which involved 25,578 participants and aimed to evaluate the Galleri multi-cancer early detection test [1][5] Group 1: Study Results - The PATHFINDER 2 study demonstrated that adding Galleri to standard cancer screening significantly increased cancer detection rates compared to the previous PATHFINDER study [2] - In the PATHFINDER study, Galleri had a positive predictive value (PPV) of 43%, specificity of 99.5%, and cancer signal origin (CSO) accuracy of 88%. The PATHFINDER 2 study showed a substantially higher PPV while maintaining consistent CSO accuracy and specificity [3] Group 2: Safety and Regulatory Aspects - No serious safety concerns were reported in the PATHFINDER 2 study, indicating a favorable safety profile for the Galleri test [4] - GRAIL plans to submit the PATHFINDER 2 study results to the U.S. FDA as part of the Galleri premarket approval application, which is currently in process under a Breakthrough Device Designation [5][6] Group 3: Future Directions - Detailed results from the PATHFINDER 2 study are expected to be presented at a leading international oncology meeting later this year [6] - The study aims to evaluate the Galleri test's performance across various measures, including PPV, negative predictive value (NPV), sensitivity, specificity, and CSO prediction accuracy [7]