Overview
- FDA staff reviewers told advisers they had no major unresolved concerns about Galleri’s laboratory accuracy or safety, leaving the Molecular and Clinical Genetics Panel to weigh clinical labeling and benefits.
- The committee is meeting on Sept. 23 to review GRAIL’s premarket approval file and to vote on whether the evidence supports Galleri’s use for screening adults 50 and older.
- Pivotal studies show very high specificity—about 99.7%—but only modest overall 12‑month sensitivity of roughly 31–35%, with much better detection for some cancers that lack current screening and worse detection for cancers already screened.
- The U.K. randomized trial did not show a statistically significant drop in late‑stage (stage IV) diagnoses on its prespecified endpoint, a key point advisers must reconcile with results from U.S. PATHFINDER2 and bridging analyses.
- Galleri is already sold as a prescription lab test for about $799 with limited insurer coverage; an FDA authorization would likely expand reimbursement, guideline use and post‑approval data collection while raising questions about follow‑up testing, patient anxiety and clinical workflows.