WASHINGTON — The U.S. Food and Drug Administration plans to convene an advisory panel in September to review Grail’s Galleri multi-cancer screening test, a key step in the company’s bid to win regulatory approval for a blood test designed to detect signals from more than 50 types of cancer.
Grail said on Friday that the FDA would seek advice from outside experts as it reviews the company’s application for premarket approval, the agency’s most stringent review pathway for medical devices. The FDA is not required to follow the panel’s recommendation.
Galleri is already marketed in the United States as a laboratory-developed test but has not been approved or cleared by the FDA. Grail submitted the final portion of its premarket approval application on Jan. 29, including data from its large U.S. PATHFINDER 2 study and the U.K.-based NHS-Galleri trial.
The test analyzes molecular signals released by tumors into the bloodstream from a single blood sample, using artificial intelligence and machine-learning methods to identify potential cancer signals and predict where they originated. Grail says the test is intended to supplement, rather than replace, established screening methods such as mammograms and colonoscopies.
The FDA review comes after mixed results from the three-year NHS-Galleri trial, which enrolled asymptomatic adults ages 50 to 77. The trial did not show a statistically significant improvement in early cancer detection or a reduction in late-stage cancer diagnoses compared with standard care across its primary analysis. By the third screening round, however, the test was associated with a 26% reduction in stage IV diagnoses for 12 specified cancers, while combining Galleri with standard screening increased cancer detection compared with standard screening alone.
Grail also reported results from PATHFINDER 2, involving more than 35,000 participants in the United States and Canada. The company said adding Galleri to recommended screening for breast, colorectal, cervical and lung cancers substantially increased the number of cancers detected, with 71% of cancers identified by the test reported at stages I through III.
The regulatory review is significant because the FDA has not previously approved a multi-cancer early-detection test. The agency held a 2023 advisory committee meeting to discuss scientific, clinical and study-design considerations for such tests.
Grail’s application remains under FDA review, with the advisory meeting in September the next officially reported step in the regulatory process.
