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FDA Advisory Panel to Vote on Galleri Approval September 23

By Drooid · Sep 23, 2026, 11:07 PM UTC · How we work

Summary

FDA Panel Votes

The FDA advisory panel will vote on recommending approval of Grail's Galleri multi-cancer blood test on September 23, 2026.
Galleri costs $949 per test and could qualify for Medicare reimbursement if approved.
FDA reviewers found no major safety concerns and reported 99.85% specificity in PATHFINDER 2.
In PATHFINDER 2, Galleri showed 35.0% 12-month sensitivity.
The test achieved a 77.0% positive predictive value.

Summary

GRAIL Shares Surge

GRAIL shares surged 33.7% to $107.97 after the FDA released the Galleri briefing package.
The FDA indicated no outstanding questions on Galleri's primary safety analysis ahead of the panel meeting.
Neither Galleri nor Abbott Laboratories' Cancerguard have FDA approval, limiting guideline inclusion and routine insurance coverage.
GRAIL reported $42.6 million Q2 test revenue, a $110.2 million net loss, and $861.6 million cash as of June 30.

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FDA Panel Votes

The FDA advisory panel will vote on recommending approval of Grail's Galleri multi-cancer blood test on September 23, 2026.
Galleri costs $949 per test and could qualify for Medicare reimbursement if approved.
FDA reviewers found no major safety concerns and reported 99.85% specificity in PATHFINDER 2.
In PATHFINDER 2, Galleri showed 35.0% 12-month sensitivity.
The test achieved a 77.0% positive predictive value.

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