Grail, Inc.(US:GRAL) Prnewswire·2025-10-17 22:08Core Insights - GRAIL, Inc. announced positive results from the PATHFINDER 2 study, demonstrating the effectiveness of the Galleri multi-cancer early detection test in identifying cancers at earlier stages and increasing detection rates significantly [1][2][4]. Group 1: Study Overview - PATHFINDER 2 is the largest U.S. multi-cancer early detection interventional study, involving 35,878 participants aged 50 and older with no clinical suspicion of cancer [1][11]. - The study evaluated the safety and performance of the Galleri test alongside standard cancer screenings, with results from 25,578 participants analyzed for performance and 25,114 for safety [1][2]. Group 2: Detection Rates and Performance - Adding Galleri to standard screenings for breast, cervical, colorectal, and lung cancers resulted in a more than seven-fold increase in cancer detection rates [2][7]. - Approximately 53.5% of new cancers detected by Galleri were stage I or II, and 69.3% were detected at stages I-III, indicating earlier detection [3][4]. - Galleri demonstrated a cancer signal detection rate of 0.93%, with a cancer detection rate of 0.57% and a positive predictive value of 61.6% [4][6]. Group 3: Diagnostic Efficiency - Galleri accurately identified the cancer signal origin 92% of the time, leading to efficient diagnostic evaluations with a median resolution time of 46 days [7][8]. - Only 0.6% of participants underwent invasive procedures, with invasive procedures being twice as common in participants diagnosed with cancer compared to those without [7][8]. Group 4: Future Plans and Regulatory Submission - GRAIL plans to submit data from the PATHFINDER 2 study to the U.S. FDA as part of the Galleri premarket approval application, expected to be completed in the first half of 2026 [8][9].