GRAIL, Inc. received a favorable vote from the Molecular and Clinical Genetics Devices Panel of the Medical Devices Advisory Committee (the Committee) of the U.S. Food and Drug Administration (FDA) for the approval of the Premarket Approval (PMA) application of the Galleri multi-cancer early detection test (MCED).

In three separate votes, the 10 voting members of the Committee considered Galleri's safety, effectiveness and overall benefit-risk profile for screening for the early detection of multiple types of cancer in adults aged 50 years and older. The Committee voted seven to two with one abstention that the benefits of Galleri outweigh its risks, unanimously in support of Galleri's safety, and six to four in support of Galleri's effectiveness.

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.

The FDA convenes advisory committees to obtain independent expert advice. The agency is not bound by the Committee's recommendations, though it takes them into consideration when making final regulatory decisions. The FDA is expected to make a final decision on the Galleri PMA in the coming months.

Additional reading

Study shows promise of multicancer early detection tests

Read GRAIL's announcement here