FDA Advisory Committee Votes to Approve Grail Cancer Test

Grail saw its stock price rise following a favorable vote by a Food and Drug Administration advisory committee regarding the Galleri multi-cancer early detection test. The Molecular and Clinical Genetics Devices Panel of the Medical Devices Advisory Committee evaluated the test's safety, effectiveness, and benefit-risk profile, a step expected to lead to formal pre-market approval.

The company is utilizing data from the PATHFINDER 2 study in the United States and the NHS-Galleri study in England to prove the test's efficacy. Galleri is designed to detect 12 deadly cancers that account for two-thirds of all cancer-related deaths.

While the test is currently available to patients who pay out-of-pocket, Grail is seeking widespread adoption by medical insurers. The company views FDA approval as a practical prerequisite for securing insurance coverage for the test.