Grail's Q3 Sales Surge as FDA Submission for Galleri Cancer Test Approaches

Grail, a California-based biotech company, has reported a significant increase in third-quarter sales, driven primarily by the growing adoption of its Galleri multicancer early detection blood test. The company also announced a more definitive timeline for its FDA submission, signaling potential advancements in cancer diagnostics and market expansion.

Strong Financial Performance

Grail's third-quarter revenue reached $36.2 million, marking a 26% year-over-year increase. The Galleri blood test was the primary contributor to this growth, accounting for $32.8 million of the total revenue. This represents a substantial 39% increase in Galleri sales compared to the same period last year, with over 45,000 tests sold in the quarter.

Galleri Test Gains Traction

The Galleri test, a multicancer early detection blood test, has shown promising commercial potential despite not yet receiving FDA approval. Nearly all of Grail's revenue from the test came from the U.S. market, where it is currently available for commercial use. The test's ability to detect multiple types of cancer through a simple blood draw has garnered significant interest from healthcare providers and patients alike.

FDA Submission Timeline Accelerated

In a notable development, Grail CEO Bob Ragusa announced that the company now expects to complete its premarket approval (PMA) application for the Galleri test in the first quarter of 2026. This timeline is earlier than previously anticipated, as the company had initially guided for submission in the first half of next year.

The PMA application will include new trial results and data from a large-scale study conducted in collaboration with the UK's National Health Service. An FDA approval could potentially pave the way for insurance coverage and wider adoption of the Galleri test, significantly expanding Grail's market reach and sales potential.