GRAIL, Inc. (NASDAQ:GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced that the U.S. Food and Drug Administration's (FDA) Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is scheduled to meet on Sept. 23, 2026 to review the Premarket Approval (PMA) application for the Galleri® multi-cancer early detection (MCED) blood test.

The Galleri test is designed to detect cancer-specific methylation patterns shared by many types of cancer before symptoms appear, including cancers that do not have recommended screening today. When a cancer signal is detected, Galleri is designed to predict the cancer signal origin with high accuracy to help guide diagnostic evaluation. The test is intended to be used in addition to, and not as a replacement for, guideline-recommended screenings.