Talk Bio

GRAIL announced topline results from the NHS-Galleri trial on February 19, 2026, involving 142,000 participants aged 50-77 over three years. 1 2 The trial failed to meet its primary endpoint of statistically significant reduction in combined Stage III-IV cancer diagnoses, though a favorable trend was observed, particularly a substantial reduction in Stage IV diagnoses. 1 2 Galleri showed increased Stage I and II detection for deadly cancers and a four-fold higher cancer detection rate; test performance (PPV, specificity, CSO accuracy) was consistent with prior studies. 1 No serious safety concerns reported; GRAIL plans U.S. sales force expansion based on these and PATHFINDER 2 results, despite analysts citing risks to FDA approval and Medicare coverage. 1 2 Company shares tumbled about 50% following the announcement. 2 Sources: 1. https://grail.com/press-releases/landmark-nhs-galleri-trial-demonstrates-a-substantial-reduction-in-stage-iv-cancer-diagnoses-increased-stage-i-a...