Grail’s Galleri Test Misses Main Goal in Large NHS Trial

Overview

• Grail acknowledged the randomized study did not achieve a statistically significant reduction in stage 3–4 cancers, its predefined primary endpoint.
• Executives cited fewer stage 4 and more stage 3 diagnoses as a possible sign of earlier detection, with full data slated for a spring cancer meeting.
• Independent researchers criticized the outcome, with some calling the study a failure despite the secondary signals.
• The trial enrolled 142,000 adults aged 50–77 in England with three annual blood draws and three years of follow-up, targeting a 20% drop in advanced cancers.
• Shares fell about 50% as questions mount over a test sold in the U.S. since 2021 for $949 without FDA approval, with an application pending and Medicare coverage not guaranteed under a new law.