An FDA advisory committee has voted in favor of GRAIL’s Galleri multi-cancer early detection (MCED) test, marking the first advisory committee review of an MCED test and the first Premarket Approval (PMA) application for an MCED test, according to GRAIL.
The FDA’s Molecular and Clinical Genetics Devices Panel of the Medical Devices Advisory Committee evaluated Galleri for screening adults aged 50 years and older for the early detection of multiple types of cancer.
Committee evaluates safety and effectiveness
The 10 voting members considered three questions related to the test’s safety, effectiveness, and overall benefit-risk profile. The committee voted 7–2, with one abstention, that Galleri’s benefits outweigh its risks. Safety received unanimous support, while effectiveness received a 6–4 vote.
The FDA is not bound by advisory committee recommendations but considers them when making final regulatory decisions. The agency is expected to decide on GRAIL’s Galleri PMA in the coming months. If approved, Galleri would be the first FDA-approved MCED test on the market, according to GRAIL.
Blood-based test targets multiple cancers
Galleri is a blood-based test designed to detect cancer-specific methylation patterns shared by multiple cancer types before symptoms appear. The test screens for more than 50 types of cancer, including cancers without recommended screening options, according to the company. When a cancer signal is detected, the test is designed to predict its origin to help guide diagnostic evaluation.
The test is intended to supplement—not replace—guideline-recommended cancer screening.
“Today’s vote reinforces the strength of Galleri's clinical evidence. We believe the panel’s recommendations reaffirm a high evidence bar that GRAIL has set for a multi-cancer early detection test,” said Josh Ofman, MD, MSHS, CEO at GRAIL, in a press release.
"We are heartened by the more than 200 physicians, nurses, professional societies, patients, patient advocates, and others who shared their support for Galleri through the written public docket and open comment period during the panel," Ofman said. "Their voices reflect the real-world urgency of finding more cancers, when outcomes can be improved."
GRAIL said Galleri’s clinical development program includes large prospective studies, including PATHFINDER 2 in North America and the NHS–Galleri trial in England. The company reported that, in clinical studies, Galleri detected approximately four to seven times more cancers than standard of care alone, with most Galleri-detected cancers identified at earlier stages. These findings are company-reported and form part of the evidence under FDA review.
Note: This news summary was generated by AI based on a published press release, followed by a review from human editors.
