Grail reports results from PATHFINDER 2 study

Grail (GRAL) announced positive top-line performance and safety results from the pre-specified analysis of the first 25,578 participants in GRAIL’s registrational PATHFINDER 2 study. PATHFINDER 2 was initiated in 2021 to evaluate the safety and performance of the Galleri multi-cancer early detection, or MCED, test when added to standard of care single cancer screening in 35,878 adults over 50 years of age with no clinical suspicion of cancer. In the previously published PATHFINDER study, adding Galleri to standard of care cancer screening more than doubled the overall number of cancers detected by screening. In PATHFINDER 2, adding Galleri to standard of care screening demonstrated substantially greater additional cancer detection than in PATHFINDER. In PATHFINDER, Galleri demonstrated a positive predictive value, or likelihood that a positive Galleri test was confirmed to be cancer, of 43%; specificity of 99.5%; and 88% cancer signal origin accuracy. PATHFINDER 2 study results will be submitted to the FDA as part of the Galleri premarket approval application, or PMA, along with data from the prevalent screening round of the NHS-Galleri trial. In addition, GRAIL will submit to the FDA bridging analyses to compare performance of the version of Galleri used in the PATHFINDER 2 study and the NHS-Galleri trial to the updated version that GRAIL plans to submit to the FDA for premarket approval. The PMA for Galleri is currently in process with a modular submission under a Breakthrough Device Designation from the FDA. GRAIL expects to complete the PMA modular submission in the first half of 2026.