FDA Staff Find No Major Concerns With Galleri Multicancer Early Detection Test

FDA review staff reported no major concerns about the safety, accuracy, risks or benefits of the Galleri multicancer early detection (MCED) blood test in briefing documents released ahead of a Wednesday advisory committee meeting. Galleri is a cell-free DNA methylation-based liquid biopsy designed to screen for signals from dozens of cancer types, most of which currently have no recommended screening test. A favourable agency review substantially improves the odds of the first regulatory approval for an MCED assay, which would open a new category of population-level cancer screening. The advisory committee vote is non-binding, and questions about false positives, diagnostic follow-up burden and mortality benefit remain to be debated.