GRAIL Announces Positive Top-Line Results from PATHFINDER 2 Study

Strategic Insights -

GRAIL, Inc., a healthcare company focused on detecting cancer early, has announced positive results from the PATHFINDER 2 study, evaluating the safety and performance of its Galleri multi-cancer early detection (MCED) test in asymptomatic adults over 50 years of age. The study demonstrated substantially greater additional cancer detection than in the previous PATHFINDER study, with a positive predictive value of 43% and specificity of 99.5% in the PATHFINDER study. The PATHFINDER 2 study results will be submitted to the FDA as part of the Galleri premarket approval application.

Key Takeaways:

  • The PATHFINDER 2 study evaluated the safety and performance of the Galleri MCED test in 25,578 participants, demonstrating substantially greater additional cancer detection than in the previous PATHFINDER study.
  • The study showed a positive predictive value of 43% and specificity of 99.5% for the Galleri test, consistent with the previous PATHFINDER study.
  • The PATHFINDER 2 study results will be submitted to the FDA as part of the Galleri premarket approval application, along with data from the prevalent screening round of the NHS-Galleri trial.
  • GRAIL plans to submit to the FDA bridging analyses to compare performance of the Galleri test used in the PATHFINDER 2 study and the NHS-Galleri trial to the updated version that GRAIL plans to submit for premarket approval.
  • The PMA for Galleri is currently in process with a modular submission under a Breakthrough Device Designation from the FDA, with completion expected in the first half of 2026.
  • The PATHFINDER 2 study demonstrated no serious safety concerns, and the test showed a substantially higher positive predictive value than in the previous PATHFINDER study.
  • Josh Ofman, MD, MSHS, President at GRAIL, stated that the company is "delighted to see very encouraging performance of the Galleri MCED test as a cancer screening tool in broad intended use populations."

Statistics:

  • 25,578 participants were enrolled in the PATHFINDER 2 study.
  • The study demonstrated a positive predictive value of 43% and specificity of 99.5% for the Galleri test.
  • The PATHFINDER 2 study showed a substantially higher positive predictive value than in the previous PATHFINDER study.
  • 35,878 adults over 50 years of age with no clinical suspicion of cancer were enrolled in the PATHFINDER study.
  • The PMA for Galleri is expected to be completed in the first half of 2026.

Sources:

  • GRAIL, Inc. (2023). GRAIL Announces Positive Top-Line Results from PATHFINDER 2 Study.