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GRAIL Highlights Galleri Test Growth, Shares NHS-Galleri Trial Results
Biotech firm reports Q4 2025 earnings and provides updates on multi-cancer early detection blood test development and regulatory progress.
Published on Feb. 27, 2026
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GRAIL, the biotech company behind the Galleri multi-cancer early detection (MCED) blood test, reported its Q4 2025 earnings and provided updates on the Galleri test's commercial growth, top-line results from the randomized NHS-Galleri trial in the U.K., and progress toward FDA premarket approval.
Why it matters
GRAIL's Galleri test represents a significant advancement in cancer screening, with the potential to detect more than 50 types of cancer at their earliest stages through a simple blood draw. The NHS-Galleri trial results and FDA approval process will be closely watched as indicators of the test's real-world performance and clinical utility.
The details
GRAIL reported that the NHS-Galleri trial did not meet its primary endpoint of a statistically significant reduction in combined Stage III and Stage IV cancers, though the company described a favorable trend after the prevalent screening round. No serious safety concerns were reported among the approximately 70,000 participants who received the Galleri test. GRAIL plans to submit the detailed NHS-Galleri results for presentation at ASCO in late May and extend data collection to reevaluate the impact with more mature data. The company also disclosed full results from the PATHFINDER 2 study, which were consistent with previously presented data. GRAIL completed the final module of its premarket approval (PMA) application to the FDA for Galleri at the end of January, and the company anticipates a 12-month review period.
- GRAIL reported Q4 2025 earnings on February 20, 2026.
- The company plans to submit detailed NHS-Galleri results for presentation at ASCO in late May 2026.
- GRAIL completed the final module of its PMA application to the FDA for Galleri at the end of January 2026.
- The company anticipates a 12-month review period for the FDA's PMA application.
The players
GRAIL
A biotechnology company dedicated to the early detection of cancer through a multi-cancer blood test, Galleri. GRAIL was founded in 2016 as a spin-out from Illumina and is headquartered in Menlo Park, California.
Sir Harpal Kumar
Chief Scientific Officer at GRAIL.
Josh Ofman
President of GRAIL.
Aaron Freidin
Chief Financial Officer of GRAIL.
Andy Partridge
Chief Commercial Officer of GRAIL.
What they’re saying
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What’s next
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The takeaway
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