Will FDA advisers recommend a multi-cancer blood test for approval? They'll vote

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1. 1h ago

   FDA Advisers Back Grail Multi-Cancer Blood Test

   U.S. food and drug administration advisers voted to back grail's multi-cancer early detection blood test, concluding that its benefits outweigh its risks. The panel voted on the premarket approval application for the galleri test, which aims to spot early signs of more than fifty types of cancer before symptoms appear. While federal health advisers expressed doubts about how definitive the results may be and whether the test works, they determined there was a reasonable assurance of safety for its proposed use.

   Why it matters

   Multi-cancer early detection blood tests represent a major frontier in oncology, seeking to identify numerous malignancies from a single draw before physical symptoms emerge. Panel members emphasized that the first-of-a-kind diagnostic tool should not replace standard medical guideline-recommended cancer screenings. The advisory vote precedes a final decision by the agency regarding market approval.

   What is confirmed

   • U.S. Food and Drug Administration advisers voted to back a multi-cancer early detection blood test from Grail.
   • The test aims to spot early signs of more than 50 types of cancer before symptoms appear.
   • Panel members advised that the blood test should not be used to replace medical guideline-recommended cancer screenings.

   Still unconfirmed

   • Panel members narrowly backed the test despite doubts over its effectiveness.

   What to watch next

   • Final FDA decision on the premarket approval application for the Galleri test.
   Sources used for this update (14)

   1. Reuters — Grail rallies as FDA staff flags no major concerns for multi-cancer test
   2. NPR — Will FDA advisers recommend a multi-cancer blood test for approval? They'll vote
   3. wsj.com — Opinion | The Galleri Result That Could Matter Most
   4. Nature — Performance and safety of a multi-cancer early detection test: the PATHFINDER 2 study
   5. University of Exeter News — First papers published in major NHS cancer blood test trial
   6. Investor's Business Daily — The Holy Grail In Cancer? FDA Mulls New Blood Tests.
   7. Mayo Clinic News Network — Multicancer blood test detects 17 cancer types in large prospective study
   8. OHSU News — PATHFINDER 2 findings advance multi-cancer early detection blood testing
   9. STAT — FDA advisory panel endorses Grail blood test for cancer, saying benefits outweigh risks
   10. www.biopharmadive.com — Grail multicancer detection test wins FDA advisers’ backing
   11. medicalxpress.com — FDA panel narrowly backs multi-cancer blood test despite doubts it works
   12. www.fox5ny.com — FDA-endorsed blood test can spot early signs of more than 50 types of cancer, drugmaker says
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