One blood test could screen you for 50 cancers. Here’s why it’s controversial.

Live updates

1. 51m ago

   FDA Advisory Panel Endorses Multi-Cancer Blood Test

   An advisory panel to the Food and Drug Administration has endorsed a controversial multi-cancer early detection blood test developed by Grail. The test aims to screen for more than 50 types of cancer from a single blood draw. While recent studies including the Pathfinder 2 trial and Mayo Clinic research have highlighted the test's ability to detect multiple cancer types, the screening tool remains a subject of ongoing debate among medical experts regarding its overall performance, safety, and clinical utility.

   Why it matters

   Multi-cancer early detection tests represent a major shift in oncology by attempting to identify numerous malignancies before symptoms appear. Whether Medicare and other health insurers will eventually cover the screening tool hinges upon formal approval by the Food and Drug Administration. The recent committee vote serves as a crucial hurdle cleared on the path toward regulatory authorization.

   What is confirmed

   • An FDA advisory panel endorsed a multi-cancer early detection blood test.
   • The test is designed to screen for more than 50 types of cancer.
   • The screening technology was developed by Grail.
   • Recent evaluations of the test include the Pathfinder 2 study and research conducted at the Mayo Clinic.

   Still unconfirmed

   • Future health insurance and Medicare coverage for the screening tool will depend entirely on receiving final FDA approval.

   What to watch next

   • Final regulatory approval decision by the Food and Drug Administration
   • Decisions by Medicare and other health insurers regarding coverage for the test
   Sources used for this update (15)

   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. Scientific American — Blood test for multiple cancers clears crucial hurdle on track to FDA approval
   5. The New York Times — F.D.A. Advisory Panel Endorses Controversial Cancer Blood Test
   6. seattletimes.com — FDA advisory panel endorses controversial cancer blood test
   7. Reuters — US FDA advisers endorse Grail cancer test's benefits in key vote
   8. The Washington Post — One blood test could screen you for 50 cancers. Here’s why it’s controversial.
   9. Cleveland 19 News — New blood test can detect more than 50 types of cancer. Here’s what to know
   10. Star Tribune — Cancer blood test advances toward FDA approval after Mayo research
   11. USA Today — A controversial, cancer-detecting blood test just got backed by key FDA panel
   12. WSJ — Grail’s Multi-Cancer Blood Test Gets FDA Committee Vote for Premarket Approval
   confidence 100%