GRAIL’s Galleri Multi-Cancer Early Detection (MCED) test has received a favourable recommendation from the Molecular and Clinical Genetics Devices Panel of the US Food and Drug Administration’s (FDA) Medical Devices Advisory Committee for its Premarket Approval (PMA) application. The panel evaluated the test for screening adults aged 50 years and older for the early detection of multiple types of cancer.

In three separate votes, the 10 voting members of the committee considered Galleri’s safety, effectiveness and overall benefit-risk profile. The panel voted 7-2, with one abstention, that the benefits of Galleri outweigh its risks. It unanimously supported the test’s safety, while six members voted in favour and four against its effectiveness.

GRAIL CEO Josh Ofman said the Galleri test was developed to complement recommended cancer screening by helping identify additional cancers at earlier stages, when treatment with curative intent may be possible. He added that the company will continue working with the FDA as the agency completes its review of the PMA application.

Galleri is designed to detect cancer-specific methylation patterns in cell-free DNA obtained from a blood sample. The test is intended to identify signals associated with multiple cancer types before symptoms appear, including cancers for which no recommended screening tests currently exist. When a cancer signal is detected, the test is designed to predict its likely origin in the body to help guide follow-up diagnostic evaluation. Galleri is intended to be used alongside, rather than replace, guideline-recommended cancer screenings.

GRAIL said more than 200 physicians, nurses, professional societies, patients and patient advocates submitted comments supporting Galleri during the advisory committee process. The company said the feedback reflected the need for approaches that could identify more cancers at earlier stages.

The company’s clinical development programme includes large prospective studies, including the PATHFINDER 2 study in North America and the NHS-Galleri trial in England. GRAIL has described these as key studies supporting its PMA submission, which was filed with the FDA on January 29, 2026. The FDA had previously designated Galleri as a Breakthrough Device in 2018.

According to GRAIL, clinical studies have shown Galleri detecting substantially more cancers than standard screening alone, with many of the cancers identified at earlier stages. The company has also reported a low false-positive rate and high accuracy in predicting the likely origin of a detected cancer signal. These findings form part of the evidence submitted to the FDA for review.

The FDA advisory committee provides independent expert advice to the agency, but its recommendations are not binding. The FDA will consider the committee’s assessment along with the broader evidence before making its final decision on the Galleri PMA application.

GRAIL said it remains focused on developing cancer detection technologies based on next-generation sequencing, large-scale clinical studies, machine learning, software and automation. The company’s stated objective is to enable earlier detection of multiple cancers and support improved outcomes through earlier diagnosis.