FDA Advisory Panel Recommends Galleri Blood Test for Early Cancer Detection

A U.S. Food and Drug Administration (FDA) advisory committee has issued a positive recommendation for Galleri, a blood test designed to detect multiple cancers early.

According to Fierce Biotech on the 23rd (local time), the FDA’s Medical Devices Advisory Committee’s Molecular and Clinical Genetics Panel met that day and voted on Grail’s Galleri test.

Galleri is a test that detects multiple types of cancer with a simple blood draw and is intended for adults ages 50 and older. The goal is to screen annually and find cancer at an early stage, before symptoms appear.

The panel held three votes. The test’s use to detect certain cancers in adults ages 50 and older passed with 7 votes in favor, 2 against and 1 abstention. The panel voted unanimously in favor on the safety question.

Views were divided on efficacy, however. The question of whether the evidence demonstrated the test’s effectiveness passed narrowly, with 6 votes in favor and 4 against.

The FDA will decide whether to grant final approval within the coming months. The agency is not required to follow the advisory committee’s recommendation.

Grail has described Galleri as an innovative cancer detection technology, but confidence was shaken after the test failed to meet its primary endpoint in a large clinical trial conducted by the U.K.’s National Health Service (NHS) in February.

In preliminary data released at the time, the NHS-Galleri trial did not show a statistically significant reduction in the incidence of late-stage (stages 3 and 4) cancers when comparing the group that received the test with the group that did not.

Grail said, however, that a positive trend toward fewer stage 3-4 cancers was seen in a prespecified group of 12 deadly cancers. These included anal, bladder, colorectal, esophageal, head and neck, liver and bile duct, lung, lymphoma, myeloma, ovarian, pancreatic and stomach cancers.

Grail CEO Josh Ofman said in a statement, “This vote demonstrates the strength of the clinical evidence for Galleri,” adding, “The panel’s recommendation reaffirms the high evidentiary bar Grail has set for a multi-cancer early detection test.”

Galleri is not currently approved, but it has been sold commercially since 2021 through several telehealth testing services, including Everlywell, at a list price of $949. This year, Grail also began offering the test to members through a partnership with Hims & Hers.