GRAIL Reports Positive Results from Galleri Multi-Cancer Early Detection Test Registrational Study

Strategic Insights -

GRAIL Inc., a California-based healthcare company focused on early detection of cancer, has reported positive top-line performance and safety results from the pre-specified analysis of the first 25,578 participants in its registrational PATHFINDER 2 study. The PATHFINDER 2 study aims 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 adults over 50 years of age with no clinical suspicion of cancer. The results demonstrate substantially greater additional cancer detection than in the previous PATHFINDER study, with no serious safety concerns reported. GRAIL plans to submit the PATHFINDER 2 study results, along with data from the NHS-Galleri trial, to the US Food and Drug Administration (FDA) as part of the Galleri premarket approval application (PMA).

Key Takeaways:

  • The PATHFINDER 2 study includes 25,578 participants, exceeding the initial study sample size of 35,878 adults.
  • The Galleri multi-cancer early detection (MCED) test demonstrates substantially greater additional cancer detection than in the previous PATHFINDER study when added to standard of care cancer screening.
  • No serious safety concerns were reported in the PATHFINDER 2 study.
  • GRAIL plans to submit the PATHFINDER 2 study results, along with data from the NHS-Galleri trial, to the US Food and Drug Administration (FDA) as part of the Galleri premarket approval application (PMA).
  • 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.

Statistics:

  • 25,578 participants in the PATHFINDER 2 study
  • 35,878 adults initially planned to participate in the study
  • 2021: The year PATHFINDER 2 was initiated
  • First half of 2026: The expected completion date of the PMA modular submission
  • 2026 (first half): The expected completion date of the PMA modular submission

Sources:

  • M2 EQUITYBITES-June 19, 2025-GRAIL reports positive results from Galleri multi-cancer early detection test registrational study (C)2025 M2 COMMUNICATIONS http://www.m2.co.uk