FDA staff flags no major concerns for Grail's multi-cancer test

Grail's shares surged 35% on Monday after US Food and Drug Administration staff reviewers indicated no major concerns about the accuracy and safety of its Galleri blood test, which is designed to detect more than 50 cancers. The findings will be presented to the FDA's external advisers on Wednesday as part of the review for premarket approval.

The FDA noted it has no outstanding questions for the panel regarding the test's analytical performance, study design, and primary safety analyses. However, the agency has asked the advisers to consider whether the evidence adequately supports characterizing Galleri as an "early detection" test.

Piper Sandler analyst David Westenberg described the FDA's stance as constructive for Grail and anticipates a favorable vote. Grail's stock had previously fallen more than 20% since February after a three-year UK trial indicated that routine screening with the test did not significantly improve early detection or reduce late-stage diagnoses.

The company's January filing for FDA approval was based on data from a smaller US trial, the first year of data from the UK trial, and a bridging analysis of an earlier version of the test. Galleri, along with Abbott Laboratories' Cancerguard, is currently available under Clinical Laboratory Improvement Amendments regulations but lacks FDA approval. Such approval is crucial for widespread distribution, physician adoption, and insurance coverage. Multi-cancer early detection tests analyze tumor-shed molecular signals from a single blood draw and are intended to supplement, not replace, existing screenings like mammograms and colonoscopies. Galleri generated $136.8 million in US revenue in 2025.