Galleri de Grail Multi-Cancer Blood Test to Go Before FDA Advisory Board

The meeting, set for Sept. 23, marks the first time an FDA panel has reviewed a multi-cancer early detection test.

Grail announced that the FDA's Molecular and Clinical Genetics Committee will meet on September 23, 2026 to review the marketing authorization application for Galleri, its blood test for the early detection of multiple cancers. The company had filed its application at the end of January 2026, based on the results of the PATHFINDER 2 study, conducted on more than 25,000 participants followed for one year.

Galleri identifies cancer-specific methylation signatures before symptoms appear, including for cancer types that currently have no recommended screening, and can refer to the probable organ of origin if a signal is detected. This is the first time an FDA advisory panel has looked at a test of this type; Grail's management continues to aim for approval in early 2027.