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. Members voted six to four in support of Galleri’s effectiveness, and the safety vote was unanimous.
The FDA is expected to make a final decision on Galleri premarket approval in the coming months. While the FDA considers these votes, the agency is not bound by the committee’s recommendations.
What Is Galleri and What Does It Do?
The test — which costs $949 — studies DNA fragments shed into the bloodstream. Patients need a prescription.
In October 2025, GRAIL presented findings from a study of 25,000 healthy adults over age 50. The company said the test found cancers at earlier stages and in organs that do not have routine screening. Galleri detected cancer signals in 216 people, and 133 of them indeed had cancer. It 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, GRAIL’s vice president of medical and corporate affairs, previously told USA TODAY. If a “cancer signal” is detected, the test also provides a predicted signal origin — a clue to providers and patients about which organ to examine first.
Why Is It Controversial?
In the United States, only five cancers are widely screened for: breast, colorectal, prostate, cervical and lung cancer, with lung screening limited to high-risk patients. But 70% of cancer deaths come from cancers without a recommended screening test. That’s where Galleri hopes to help.
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.
What Does a Positive Result Mean?
A positive blood test is not a diagnosis.
Galleri can pick up indolent — or slow-growing — cancers such as chronic lymphocytic leukemia, which patients and their providers may decide not to treat or may simply monitor.
“We want to make sure that we are detecting those more aggressive cancers that really do warrant treatment,” Hall said.
Doctors involved and not involved with the study told USA TODAY they were not concerned about overdiagnosis sending people down a path of unnecessary treatment. About 1% of people receive a positive cancer detection signal, meaning 99% go about their lives and continue their normal recommended screenings.
But “a positive blood test is not a diagnosis,” Dr. Gilberto Lopes, chief of medical oncology with the 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.”
Reporting by Sara Moniuszko and David Oliver, USA TODAY / USA TODAY. USA TODAY Network via Reuters Connect.