GRAIL NHS-Galleri Results Miss Primary Endpoint

GRAIL Inc. (Nasdaq: GRAL) released results on Feb. 19, 2026, showing that the randomized NHS-Galleri trial did not meet its pre-specified primary endpoint for combined Stage III–IV cancers. Secondary analyses indicated fewer Stage IV diagnoses, and the company plans to expand its U.S. commercial operations.

NHS-Galleri Trial Outcomes and Test Performance

The NHS-Galleri trial was a prospective, randomized, controlled study of about 142,000 asymptomatic participants aged 50 to 77. It evaluated adding annual Galleri multi-cancer early-detection screening to standard care over three years, collecting three blood samples over two years. The trial focused on 12 pre-specified cancers—anus, bladder, colorectal, esophagus, head and neck, liver and bile duct, lung, lymphoma, myeloma/plasma-cell neoplasm, ovary, pancreas, and stomach—that represent roughly two-thirds of cancer deaths in England and the U.S.

The trial did not achieve a statistically significant combined reduction in Stage III–IV cancers in the intervention arm, though the company reported a favorable trend after the initial screening round. Secondary analyses showed more than a 20% reduction in Stage IV diagnoses during screening rounds two and three compared with standard care. There was also a substantial increase in absolute Stage I–II detections and fewer cancers presenting as emergencies.

Combining Galleri with standard care yielded about a four-fold higher detection rate for breast, colorectal, cervical, and high-risk lung cancers than standard care alone. Reported test-performance metrics—including positive predictive value, specificity, and Cancer Signal of Origin accuracy—aligned with prior North American studies. No serious safety issues emerged. The company noted a higher-than-expected incidence of Stage III cancers and observed improved time to diagnostic resolution throughout the trial.

Regulatory Review and Commercial Plans

Galleri’s premarket approval application (PMA) remains under review at the FDA. The submission will incorporate NHS-Galleri data on test performance and stage-shift outcomes. Galleri is a methylation-based multi-cancer early-detection test analyzing signals from more than 50 cancer types. GRAIL operates a CLIA-certified, CAP-accredited laboratory and markets Galleri as a prescription test, not as an FDA-cleared or approved device. NHS-Galleri results will inform decisions about a potential national screening program in England.

Alongside the trial results, GRAIL reported fourth-quarter and full-year 2025 financial results and announced plans to expand its U.S. field-based sales and medical teams to meet anticipated demand. The company cited NHS-Galleri and positive topline data from the PATHFINDER 2 study of about 25,000 participants as drivers for this expansion. These developments will be material for GRAL stock.

Bob Ragusa, GRAIL’s chief executive officer, said, "The NHS-Galleri trial provides the strongest evidence to date that multi-cancer early detection can shift the stage at which cancers are detected at a population level."

The trial’s failure to meet its primary endpoint complicates the regulatory outlook for Galleri and will focus attention on the FDA review and national screening deliberations in England, as stakeholders consider the secondary signals of reduced Stage IV disease and earlier-stage detection.

Next Steps

GRAIL plans to extend NHS-Galleri follow-up by six to 12 months to allow stage distributions to mature. The company is preparing detailed analyses for submission to the ASCO 2026 Annual Meeting and will incorporate NHS-Galleri metrics into its ongoing PMA engagement with the FDA as data continue to be analyzed.