GRAIL Submits FDA Premarket Approval Application for Galleri Multi-Cancer Early Detection Blood Test

GRAIL has submitted the final module of a Premarket Approval application to the US Food and Drug Administration for its Galleri multicancer early detection blood test, marking a key regulatory step toward potential clinical use of the test for population-level cancer screening.

According to the company, the submission is supported by safety and performance data from large US- and UK-based studies and builds on the test’s prior designation as an FDA Breakthrough Device in 2018. The application seeks approval of Galleri as a multicancer early detection test intended to complement existing single-cancer screening approaches.

Evidence supporting the PMA submission

The PMA submission is centered on results from 25 490 participants enrolled in the US-based PATHFINDER 2 study with 1 year of follow-up, as well as data from the first screening round of the NHS-Galleri trial, described by GRAIL as the largest randomized, controlled trial conducted to date for a multicancer early detection test. The submission also includes a bridging analysis comparing the versions of Galleri used in these studies with the updated test configuration submitted for FDA review.

The NHS-Galleri trial (NCT05611632) enrolled more than 140 000 asymptomatic adults aged 50 to 77 years in England and is evaluating the clinical utility of adding Galleri to standard cancer screening. The primary objective is to determine whether use of the test reduces the incidence of late-stage (stage III–IV) cancers compared with usual care alone. The analysis focuses initially on a prespecified group of 12 cancer types that together account for approximately two-thirds of cancer-related deaths in the United Kingdom and the United States.

Secondary end points of the NHS-Galleri trial include reductions in stage IV cancers, test performance measures such as positive predictive value and false-positive rate, cancer detection rate, safety outcomes, and health care resource utilization.

PATHFINDER 2 study design

The PATHFINDER 2 (NCT05155605) clinical trial is a prospective, multicenter interventional study enrolling approximately 35 000 US adults aged 50 years and older who are eligible for guideline-recommended cancer screening. Primary objectives include assessment of safety and test performance based on the diagnostic evaluations undertaken following a cancer signal detected result, as well as evaluation of key performance metrics including sensitivity, specificity, positive and negative predictive values, and cancer signal origin prediction accuracy.

Participants who receive a cancer signal detected result undergo additional diagnostic testing guided by the predicted cancer signal origin. Secondary objectives include evaluation of subsequent use of guideline-recommended screening procedures and participant-reported outcomes such as anxiety and satisfaction with testing.

Clinical context

Currently, routine cancer screening programs target a limited number of cancer types and are largely organ specific. Galleri is designed to detect signals associated with multiple cancers from a single blood draw, potentially identifying cancers that lack established screening tests. GRAIL has emphasized that the test is intended to be used alongside, rather than replace, existing screening modalities.

The FDA has not yet indicated a review timeline for the application. If approved, Galleri would represent the first multicancer early detection test authorized for population screening in the US.

Reference: GRAIL Submits FDA Premarket Approval Application for the Galleri® Multi-Cancer Early Detection Test. GRAIL Inc. News release. January 29, 2026. Accessed January 30, 2026. https://www.prnewswire.com/news-releases/grail-submits-fda-premarket-approval-application-for-the-galleri-multi-cancer-early-detection-test-302674611.html?tc=eml_cleartime