FDA Advisory Committee Backs Galleri Multi-Cancer Early Detection Test for Adults Aged 50 Years and Older

Clinical Summary: 

• Regulatory Update: The FDA’s Molecular and Clinical Genetics Devices Panel voted 7 to 2, with 1 abstention, that the benefits of Galleri outweigh its risks for multi-cancer screening in adults aged 50 years and older. The panel also voted unanimously in support of safety and 6 to 4 in support of effectiveness.
• Test/Intended Use: Galleri is designed to detect cancer-specific methylation patterns in blood before symptoms develop and predict the likely cancer signal origin to help guide diagnostic evaluation. The test is intended to supplement, not replace, guideline-recommended cancer screening.
• Clinical Relevance: The favorable advisory committee vote supports continued FDA review of the first premarket approval application for a multi-cancer early detection test. The committee’s recommendation is nonbinding, and the FDA has not yet made a final regulatory decision.

The US Food and Drug Administration (FDA) Molecular and Clinical Genetics Devices Panel of the Medical Devices Advisory Committee has voted in favor of the Galleri multi-cancer early detection test for screening adults aged 50 years and older.

In 3 separate votes, the 10 voting members considered the test’s safety, effectiveness, and overall benefit-risk profile. The panel voted 7 to 2, with 1 abstention, that the benefits of Galleri outweigh its risks. The committee also voted unanimously in support of the test’s safety and 6 to 4 in support of its effectiveness.

Galleri is designed to detect cancer-specific methylation patterns associated with multiple cancer types before symptoms develop, including cancers without currently recommended screening programs. When a cancer signal is detected, the test is also designed to predict the cancer signal origin to help direct further diagnostic evaluation.

The test is intended to be used in addition to, rather than as a replacement for, guideline-recommended cancer screening.

GRAIL’s clinical development program includes large prospective and randomized studies in intended-use populations, including PATHFINDER 2 in North America and the NHS-Galleri trial in England.

According to GRAIL, clinical studies have shown that Galleri can detect substantially more cancers than standard-of-care screening alone, with many of the cancers identified at earlier stages. The company also reported low false-positive rates and high accuracy in predicting cancer signal origin.

The FDA designated Galleri as a Breakthrough Device in 2018. GRAIL submitted its premarket approval application for the test to the FDA on January 29, 2026.

The advisory committee vote does not constitute FDA approval. The FDA considers advisory committee recommendations as part of its regulatory review but is not required to follow the panel’s vote.

GRAIL stated that the FDA is expected to make a final decision on the Galleri premarket approval application in the coming months.

Source: 

GRAIL. FDA Advisory Committee votes In favor of approval of GRAIL’s Galleri^® multi-cancer early detection test. Accessed on: September 24, 2026. https://grail.com/press-releases/fda-advisory-committee-votes-in-favor-of-approval-of-grails-galleri-multi-cancer-early-detection-test/