FDA panel endorses first-of-a-kind cancer blood test from Grail

Live updates

1. 44m ago

   FDA advisers endorse Grail's Galleri multi-cancer blood test

   An FDA advisory panel voted to recommend the Galleri multi-cancer early detection test from Grail for approval. The committee voted 7-2 that the benefits of the test outweigh its risks and 10-0 that the test is safe for its proposed use. However, the panel was divided on effectiveness, with a narrow 6-4 vote regarding whether the test works. The test is designed to detect early signs of more than 50 types of cancer before symptoms appear.

   Why it matters

   Early detection of cancer typically requires specific screenings for individual organs. A single blood test capable of identifying dozens of cancer types would change how clinicians screen asymptomatic patients. Grail has previously conducted large prospective studies to test the detection of 17 cancer types.

   What is confirmed

   • The FDA advisory panel voted 10-0 that the Galleri test is safe for its proposed use.
   • The committee voted 7-2 that the benefits of the Galleri test outweigh its risks.
   • Panel members split 6-4 on the question of the test's effectiveness.
   • The Galleri test aims to detect early signs of more than 50 types of cancer.
   • Grail developed the multi-cancer early detection test.

   What to watch next

   • Final FDA decision on the commercial approval of the Galleri test
   • Publication of further safety and performance data from the PATHFINDER 2 study
   Sources used for this update (14)

   1. NPR — Will FDA advisers recommend a multi-cancer blood test for approval? They'll vote
   2. Nature — Performance and safety of a multi-cancer early detection test: the PATHFINDER 2 study
   3. Mayo Clinic News Network — Multicancer blood test detects 17 cancer types in large prospective study
   4. AP News — FDA panel endorses first-of-a-kind cancer blood test from Grail
   5. Scientific American — Blood test for multiple cancers clears crucial hurdle on track to FDA approval
   6. ft.com — Cancer-screen blood test wins tepid support from US drug advisory panel
   7. The New York Times — F.D.A. Advisory Panel Endorses Controversial Cancer Blood Test
   8. seattletimes.com — FDA advisory panel endorses controversial cancer blood test
   9. PR Newswire — FDA Advisory Committee Votes In Favor of Approval of GRAIL's Galleri® Multi-Cancer Early Detection Test
   10. Reuters — US FDA advisers endorse Grail cancer test's benefits in key vote
   11. medicalxpress.com — FDA panel narrowly backs multi-cancer blood test despite doubts it works
   12. www.ntd.com — FDA Panel Backs Multi-Cancer Blood Test Despite Uncertainty Over Effectiveness
   confidence 95%