Grail, Inc.(US:GRAL)2025-10-20 12:00PATHFINDER 2 Study Key Findings - The PATHFINDER 2 study evaluated the performance and safety of the Galleri MCED test in individuals eligible for cancer screening [15, 18] - The study involved approximately 35,000 participants [11, 16] - The observed positive predictive value (PPV) across all cancers was approximately 61.6% (95% CI: 54.9-67.8%) [19] - The negative predictive value (NPV) was 99.1% (95% CI: 99.0-99.3%) [19] - The episode sensitivity was 40.4% (95% CI: 35.3-45.8%), and specificity was 99.6% (95% CI: 99.5-99.7%) [19] - For 12 cancers responsible for two-thirds of US cancer deaths, the episode sensitivity was 73.7% (65.6-80.4%) [23, 25] - MCED testing increased the number of screen-detected cancers by over 7 times when added to recommended screening [26, 43] - 73% of all MCED-detected cancers do not have recommended screening options [32] - The median time to diagnostic resolution for true positive MCED test results was 36 days (IQR: 24-61 days) [38] - 0.6% of participants had an invasive procedure to evaluate a positive MCED result, with no serious study-related adverse events reported at the time of initial analysis [41, 42]