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A controversial blood test aimed at detecting multiple cancers was backed by a U.S. Food and Drug Administration panel this week.
On Wednesday, Sept. 23, the FDA’s Molecular and Clinical Genetics Devices Panel of the Medical Devices Advisory Committee announced a favorable vote for the technology, called the Galleri multi-cancer early detection (MCED) test.
GRAIL, the company behind Galleri, said the 10 voting members considered the test’s “safety, effectiveness and overall benefit-risk profile for screening for the early detection of multiple types of cancer in adults aged 50 years and older,” according to a news release.
On whether the benefits of Galleri outweigh its risks, the committee voted seven to two with one abstention, six to four in support of Galleri’s effectiveness, and for safety, the vote was unanimously in support.
The FDA is expected to make a final decision on Galleri premarket approval in the coming months, the release added. While the FDA takes these votes into considerations, the agency is not bound by the committee’s recommendations.
Here’s what to know about the test.
What is Galleri and what does it do?
The test – which costs $949 – studies DNA fragments shed into the bloodstream. Patients need a prescription before pulling up their sleeves.
In October 2025, GRAIL presented findings from a study across 25,000 healthy adults over the age of 50. The test, the company said, found cancers at earlier stages and in organs that don’t have routine screening. Galleri discovered cancer signals in 216 people, and 133 of them indeed had cancer. It also correctly predicted the cancer’s origin 92% of the time.
“We’re able to isolate those DNA fragments, sequence them and look for those tumor-specific markers from the blood,” Megan Hall, the vice president of medical and corporate affairs at GRAIL, previously told USA TODAY. If a “cancer signal” is detected, it also provides a cancer signal origin prediction, or a clue to the providers and the patient which organ that signal could be coming from. If that origin was the pancreas, for example, doctors would know where to start looking for the possible cancer.
Why is it controversial?
In the United States, only five cancers are widely screen for: breast, colorectal, prostate, cervical and lung cancer, the latter in only high-risk patients. But 70% of cancer deaths come from those without a recommended screening test. That’s where Galleri hopes to split the difference.
But its efficacy has been called into question.
A major trial conducted with England’s National Health Service did not show a significant reduction in late-stage cancer diagnoses for patients who took the Galleri test, the company shared earlier this year.
“The key plain takeaway: (This type of testing) may complement current screening by identifying lethal cancers that are otherwise undetected earlier and with limited downstream burden,” Dr. Mohamed Abazeed, chair and professor of radiation oncology at Northwestern University, who was not involved with the study, previously told USA TODAY.
‘A positive blood test is not a diagnosis’
Beware also that Galleri does and can pick up indolent cancers – i.e. slow-growing ones like Chronic lymphocytic leukemia – which you and your provider may decide not to treat, or just keep an eye on.
“We want to make sure that we are detecting those more aggressive cancers that really do warrant treatment,” says Hall.
Overall, doctors both involved with and not involved with the study weren’t concerned about the Galleri test and overdiagnosis, or sending people down a path of unnecessary endless treatment. About 1% of people receive a positive cancer detection signal, which means 99% live their lives and go about their normal recommended screenings.
But “a positive blood test is not a diagnosis,” Dr. Gilberto Lopes, chief of medical oncology with University of Miami Health System’s Sylvester Comprehensive Cancer Center, previously told USA TODAY. “You still need imaging, sometimes a biopsy. That takes time and resources.”