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FDA Advisory Panel Backs Grail’s Galleri Blood Test but Flags Key Evidence Gaps

The panel’s votes clear a major regulatory hurdle and send the application to the FDA for a final decision while regulators seek strict labeling and more outcome data.

FDA Advisory Panel Reviews GRAIL’s Galleri Multi‑Cancer Blood Test

NHS‑Backed Trial of Galleri Blood Test Fails to Meet Main Goal

Galleri Blood Test Confirms Cancer in 62% of Positive Screens in Major Trial

Samsung Invests $110 Million in Grail to Bring Galleri Cancer Test to Asia