A US Food and Drug Administration advisory panel has voted in favor of GRAIL’s Galleri multi-cancer early detection test, clearing a major hurdle for the blood test as regulators consider whether to approve it for adults aged 50 and older.

 

The Molecular and Clinical Genetics Devices Panel of the FDA’s Medical Devices Advisory Committee voted 7-2, with one abstention, that the benefits of Galleri outweigh its risks. The panel voted unanimously that the test is safe, while its effectiveness drew a 6-4 vote.

 

The FDA is not bound by the panel’s recommendations and will make the final regulatory decision. The agency is expected to rule on GRAIL’s application in the coming months.

 

“The Galleri test was developed to improve the effectiveness and efficiency of our national cancer screening program by adding multi-cancer early detection to recommended screening—helping find more cancers safely, when they may be easier and less costly to treat, and it still may be possible for a patient to receive treatment with curative intent,” said Josh Ofman, CEO at GRAIL. 

 

“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. GRAIL is committed to working with the FDA as it completes its review of Galleri, the first PMA submission for a multi-cancer early detection test.”

 

Galleri is designed to detect cancer-associated methylation patterns in blood before symptoms appear and across multiple cancer types, including cancers for which no recommended screening currently exists. When the test detects a cancer signal, it is designed to identify where in the body that signal originated, helping guide follow-up diagnostic testing.

 

GRAIL says Galleri is intended to complement—not replace—existing guideline-recommended cancer screenings.

 

“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,” said Ofman. “Their voices reflect the real-world urgency of finding more cancers, when outcomes can be improved.”

 

The company says Galleri is supported by large prospective and randomized studies, including the PATHFINDER 2 study in North America and the NHS-Galleri trial in England. According to GRAIL, clinical studies have found four to seven times more cancers with Galleri than with standard screening alone, with most cancers detected by the test found at earlier stages.

 

The company also says the test has maintained a low false-positive rate and high accuracy in predicting the likely origin of a detected cancer signal.

 

The panel’s vote marks an important step in the regulatory review of a technology aimed at detecting multiple cancers through a single blood test. But the recommendation does not amount to FDA approval, and the agency's final decision remains pending.