Despite a major trial setback earlier this year and increasing questions over its efficacy, medtech Grail has beaten the odds and seen a positive recommendation for its multi-cancer blood test Galleri from FDA advisors.
On Wednesday, the molecular and clinical genetics panel of the FDA’s medical devices advisory committee sat down and debated Grail’s hotly anticipated Galleri test. The tech works as a simple blood draw that can detect a range of cancers, including some of the most common, and is designed for use in people over the age of 50 years old.
The concept is to pick up cancers at earlier stages, potentially before symptoms arise, via annual testing, and potentially negate more invasive procedures and time-consuming imaging.
Now, the company is one step closer to achieving a premarket approval for Galleri in the U.S. following this week's vote of confidence from the panel of FDA device advisors.
The meeting consisted of three votes. The first saw a comfortable 7-2 passing grade for Galleri with one abstention, with the panel finding the test could be used to find certain cancers in adults aged 50 or over. On the question of the test's safety, Galleri won unanimous backing from the panel.
It was much closer when it came to efficacy, where the committee voted 6-4 on whether the evidence could vouch for the test's effectiveness. A final decision on approval will now be made by the FDA in the coming months, which does not have to follow the advice of the advisory committee.
Grail has long hailed its tech as being revolutionary in cancer detection—but that confidence was shaken in February when a major National Health Service (NHS) trial of its Galleri test in the U.K. missed its primary endpoint.
In topline data revealed at the time, Grail said the NHS-Galleri trial didn't show a statistically significant reduction in later-stage (3 and 4) combined cancers among people who received the Galleri test compared with those who did not.
Grail did, however, look for the positives and found that there was “a favorable trend toward fewer stage III-IV cancers in a pre-specified group of 12 deadly cancers in the intervention arm after the prevalent screening round.”
The deadly disease types included in the prespecified group were cancers of the anus, bladder, colorectal, esophagus, head and neck, liver/bile duct, lung, lymphoma, myeloma/plasma cell neoplasm, ovary, pancreas and stomach.
Josh Ofman, MD, MSHS, CEO at Grail, said in a Wednesday statement: “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.”
While Galleri has no present approvals, it has been available commercially via several telehealth testing services, including Everlywell, since 2021, with its list price sitting at $949. This year, the company also teamed up with Hims & Hers to sell its test privately to its members.