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

 Cancer Detection and Positive Predictive Value Substantially Higher Than the Previously Published PATHFINDER Study

GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today 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 (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 (PPV), or likelihood that a positive Galleri test was confirmed to be cancer, of 43%; specificity of 99.5%; and 88% cancer signal origin (CSO) accuracy. Data from evaluable PATHFINDER 2 participants with 12 months of follow-up showed a substantially higher PPV than that observed in the PATHFINDER study. CSO accuracy and specificity were consistent with that observed in the PATHFINDER study.

There were no serious safety concerns reported in PATHFINDER 2.

https://www.prnewswire.com/news-releases/grail-announces-positive-top-line-results-from-the-galleri-pathfinder-2-registrational-study-302485221.html