Grail's cancer blood test nears landmark FDA approval, but insurance coverage looms
GRAL•An FDA advisory panel said the potential benefits of Grail's Galleri test outweigh its risks, moving it closer to approval. Approval could make the test eligible for Medicare coverage starting in 2028, while patients currently pay about $700 out of pocket.
1. FDA review advances
The FDA is not required to follow its advisory panel's recommendation, though it often does. Wall Street analysts expect the agency to rule in Grail's favor in the coming months.
2. Coverage could expand
Galleri is marketed as a laboratory-developed test and is not covered by Medicare. Under a US law passed this year, FDA approval could make it eligible for Medicare coverage starting in 2028; private insurers would also likely have to cover it if the US Preventive Services Task Force recommends its use. Analyst Elena Meng estimated widespread coverage could create a $60 billion-a-year US market by 2030, based on 120 million adults aged 50 and older taking a $500 test annually.
3. Benefits remain debated
Grail says Galleri can detect signals for more than 50 cancer types and identify their likely origin with 93.4% accuracy. A UK trial found no significant increase in early cancer detection or reduction in late-stage diagnoses versus standard care, though full results showed a 26% reduction in stage IV diagnoses across 12 deadly cancers by the third screening round. Doctors and researchers have raised concerns about follow-up costs and whether the tests reduce cancer deaths.
