FDA Panel Backs Grail's Galleri Cancer Blood Test — SkimNews
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- FDA advisory panel voted 10-0 that Grail's Galleri blood test is safe, finding "reasonable assurance" of safety
- Panel members split 6-4 on whether there is reasonable assurance the test is effective for screening multiple cancer types
- Voters concluded 7-2 with one abstention that Galleri's benefits outweigh its risks for patients meeting the criteria in the proposed indication
- Galleri is designed by biotech firm Grail as a single blood draw to screen for multiple types of cancer
- The FDA is not obligated to follow advisory panel recommendations but typically does
Why it matters: A positive FDA panel vote on Galleri puts a multi-cancer screening blood test one step closer to market, though the narrower 6-4 effectiveness vote and the FDA's discretion to ignore panel advice mean final approval is not guaranteed. Grail stands to gain a first-mover position in multi-cancer early detection if the agency follows the panel's endorsement.
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