Grail Seeks FDA Approval as Galleri Test Detects Only 40% of Cancers
Interim October 2025 data show Grail’s Galleri blood test detects roughly 40% of cancers, missing over half of cases. Grail has requested FDA approval under the most rigorous diagnostic pathway while Hims & Hers will offer the $700 test at a 25% discount to its $350 subscribers.
1. Ad Sparks Reliability Concerns
Hims & Hers ran a Super Bowl ad promoting Grail’s Galleri multi-cancer blood test, suggesting early detection access for over 50 cancer types. Critics warn the ad’s depiction of a ‘no cancer signal detected’ result could mislead patients given the test’s interim performance.
2. Interim Performance Data
Interim October 2025 results show Galleri detects roughly 40% of cancers, meaning it misses over half of true cases. Questions have emerged about its accuracy, especially for hard-to-detect cancers like pancreatic and ovarian with no routine screening.
3. Regulatory Filing Details
Grail has submitted its Galleri test for FDA review under the agency’s most rigorous medical diagnostics pathway. The company aims to secure approval as a high-risk device, potentially setting new standards for regulatory scrutiny in early cancer detection.
4. Commercial Offering and Pricing
Hims & Hers will market the Galleri test to its lab service subscribers at $700, representing a 25% discount off the list price. This partnership may drive initial uptake but raises questions about cost-effectiveness and long-term adoption.