Grail, Inc.(US:GRAL) Prnewswire·2026-01-30 00:25Core Insights - GRAIL, Inc. has submitted the final module of the Premarket Approval (PMA) application for its Galleri multi-cancer early detection (MCED) test to the FDA, marking a significant milestone in early cancer detection [1][2] - The Galleri test has been designated as a Breakthrough Device by the FDA since 2018, highlighting its potential to improve cancer screening outcomes [1][2] Company Overview - GRAIL is focused on early cancer detection using next-generation sequencing and advanced machine learning technologies, aiming to alleviate the global burden of cancer [5] - The company is headquartered in Menlo Park, California, with additional locations in Washington, D.C., North Carolina, and the United Kingdom [5] Clinical Studies - The PMA submission is based on data from the PATHFINDER 2 study, which involved 25,490 participants, and the NHS-Galleri trial, the largest randomized controlled trial of any MCED test [2][3] - The NHS-Galleri trial recruited over 140,000 asymptomatic participants aged 50 to 77, aiming to demonstrate a reduction in late-stage cancers among those who received the Galleri test [3] - The PATHFINDER 2 study evaluates the safety and performance of the Galleri test in approximately 35,000 individuals eligible for cancer screening, focusing on diagnostic evaluations and performance metrics [4] Test Performance and Objectives - The primary objective of the NHS-Galleri trial is to show a reduction in late-stage (III-IV) cancers, particularly in a pre-specified group of 12 cancer types that account for about two-thirds of cancer deaths in England and the U.S. [3] - Secondary objectives include assessing the performance of the Galleri test in terms of positive predictive value, false positive rate, cancer detection rate, and healthcare resource utilization [3][4]