Grail saw a sharp rise in third-quarter sales as it outlined a firmer FDA submission date for its Galleri cancer blood test.
The California company posted a 26% year-over-year increase in third-quarter revenue, reaching $36.2 million, with its Galleri blood test accounting for $32.8 million.
Galleri sales grew 39% in the quarter to more than 45,000 tests, with nearly all revenue coming from the U.S.
Grail’s Galleri test is a multicancer early detection blood test that is commercially available in the U.S. but not yet approved by the FDA.
The company said earlier this year that it would submit new trial results to the FDA as part of Galleri’s premarket approval application along with anticipated data from a large U.K. study conducted with the National Health Service.
Grail had previously guided the first half of next year as the expected timeline for completing its premarket approval application, but CEO Bob Ragusa said in the Nov. 12 results that the company now expects to finish its Galleri submission in the first quarter of 2026.
An FDA approval could open the door to insurance coverage and wider use, expanding Grail’s sales potential.