GRAIL Inc, a healthcare company focused on early cancer detection,, announced on Wednesday a favourable vote from the Molecular and Clinical Genetics Devices Panel of the Medical Devices Advisory Committee of the US Food and Drug Administration (FDA) for the approval of the Premarket Approval (PMA) application for GRAIL's Galleri multi-cancer early detection test (MCED).

In three separate votes, the Committee's 10 voting members 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.

According to GRAIL, Galleri the only MCED test supported by large interventional and randomised controlled studies in intended-use populations, including FDA-approved Investigational Device Exemption studies (IDEs), namely PATHFINDER 2 in North America and the landmark NHS-Galleri trial in England. In clinical studies, Galleri has detected approximately four to seven times more cancers compared to standard of care alone, with most Galleri-detected cancers found at earlier stages, when treatment with curative intent may be possible, while maintaining a low false-positive rate and high Cancer Signal Origin prediction accuracy.

Galleri was designated by the FDA as a Breakthrough Device in 2018. GRAIL submitted its PMA application for Galleri to the FDA in January 2026.

The FDA is expected to make a final decision on the Galleri PMA in the coming months.