Biotechnology company GRAIL, Inc. (NASDAQ:GRAL) announced on Monday an update on its PATHFINDER 2 and NHS-Galleri trials for the Galleri multi-cancer early detection (MCED) test.

PATHFINDER 2 has completed enrollment of over 35,000 eligible participants across 30+ North American healthcare institutions. This prospective study assesses Galleri's safety and performance in individuals aged 50 years and older, per FDA-approved investigational device exemption (IDE).

Key objectives include evaluating diagnostic efficacy, positive predictive value, and cancer signal origin prediction accuracy. Secondary aims involve assessing post-test screening utilization and participant-reported outcomes regarding anxiety and satisfaction.

PATHFINDER 2 collaborators encompass prominent US institutions such as Cleveland Clinic, Duke University Health System, and Mayo Clinic. Meanwhile, NHS-Galleri, initiated in 2021 with over 140,000 participants aged 50 to 77, examines Galleri's integration into NHS cancer screening protocols.

The trial's primary goal is to determine if early detection reduces late-stage cancer incidences. Participants undergo three blood draws over two years, with half receiving immediate Galleri testing and the remainder for future analysis, maintaining study blinding.

Collaborators include Queen Mary University of London, King's College London Cancer Prevention Trials Unit, and NHS England.