Key facts
- The Galleri test detects DNA "fingerprints" from over 50 cancers.
- The test aims to identify cancer early when treatment options are more effective.
- The FDA approved the Galleri test on September 23, 2026.
- The NHS-Galleri trial showed a 14% reduction in stage 4 diagnoses for 12 deadly cancers.
- The test correctly predicted cancer location 92.5% of the time in the NHS-Galleri trial.
The U.S. Food and Drug Administration has approved the Galleri blood test, a significant step for multi-cancer early detection (MCED) technologies. The test, developed by GRAIL, Inc., analyzes cell-free DNA in the bloodstream for cancer-specific methylation patterns, aiming to detect over 50 types of cancer, including those typically diagnosed late.
The approval follows the NHS-Galleri trial, which involved over 142,000 adults. The trial showed encouraging results, including a 14% reduction in stage 4 diagnoses and an increase in early-stage cancer detection for several deadly cancers. The test also demonstrated a positive predictive value of 52% and high specificity.
However, the trial did not meet its primary endpoint of a statistically significant drop in combined stage 3 and 4 cancers within one year of follow-up. Experts like Maximilian Diehn and Douglas K. Owens from Stanford Medicine express skepticism, suggesting the tests may not yet be ready for widespread clinical use, despite their commercial availability since 2021.