GRAIL’s Galleri wins FDA panel backing, Medicare coverage pathway begins in 2029

Nov 10, 2026 01:05 (3h ago)

GRAIL received FDA Advisory Committee backing for Galleri, with a potential FDA decision expected by early Q1 2027.
GRAIL completed 174,000 Galleri tests in the first nine months of 2026, up 36% year over year, while the listed price is $949.
Medicare coverage cannot begin before January 1, 2029, and requires FDA approval or clearance plus a favorable CMS determination and applicable age eligibility.

GRAIL Inc.’s Galleri multi-cancer early detection test received favorable backing from an FDA Advisory Committee on September 23, 2026, supporting a potential FDA decision by early Q1 2027 while label negotiations continue. The prescription laboratory-developed blood test, which detects tumor DNA and methylation patterns to identify signals from more than 140 cancer types, is designed to supplement rather than replace recommended screenings. Galleri is not currently FDA-approved or covered by Medicare and lists at $949, although promotional and provider pricing can be lower. The Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act, signed February 3, 2026, permits coverage no earlier than January 1, 2029, subject to FDA approval or clearance and a favorable CMS determination. Its age phase-in may exclude beneficiaries who are already 70 or older unless the U.S. Preventive Services Task Force gives the test an A or B rating. GRAIL completed 174,000 tests in the first nine months of 2026, up 36% year over year, while third-quarter revenue rose 4% and screening revenue increased 14%. The company is expanding sales and health-system integrations, but lower pricing and higher overhead reduced adjusted gross margin to 42%, and the suspended Illumina royalty is due to resume in late December 2026.