An advisory committee to the Food and Drug Administration recommended on Wednesday that the agency approve a blood test designed to detect various cancers in the early stages, despite concerns among doctors about the test’s efficacy.
The test, which is called Galleri and is manufactured by Grail, is one of a handful of so-called early detection blood tests that claim to be able to find multiple cancers at early stages. The idea of catching cancers sooner with a simple blood test has generated tremendous hope. But oncologists and screening experts have expressed concerns that Grail’s test has not been shown to reduce cancer deaths, and they have warned that the possible risks, including harm to patients and increased health care costs, may outweigh any potential benefits.
The test works by analyzing DNA fragments in the blood for certain patterns indicative of cancer. While it has not yet been approved by the F.D.A., it has been available to people in the United States since 2021 through a regulatory exception. Hundreds of thousands of people have taken a Galleri test, including 117,000 in the first half of this year. (That number does not count those who have taken the test as part of research.)
But there is no data from randomized controlled trials that shows that Galleri or any similar test reduces cancer deaths — the gold standard for cancer screening. Grail conducted a large randomized trial in the United Kingdom to assess whether the test shifted cancer diagnoses earlier, with the thinking being that earlier-stage cancers have better prognoses. But the company announced in February that the test failed to reduce Stage 3 and 4 cancer diagnoses.
“That’s why nobody in the oncology community is recommending this test,” said Dr. Scott Ramsey, the director of the Hutchinson Institute for Cancer Outcomes Research at Fred Hutch Cancer Center in Washington. Dr. Ramsey is leading a study funded by the National Cancer Institute, or N.C.I., to assess the feasibility of using multi-cancer detection tests.
Currently, most patients must pay out of pocket for Grail’s test, which has a list price of $949. But the company spent millions successfully lobbying for legislation that would authorize Medicare to cover the test beginning in 2028 if the F.D.A. approves it. Other insurers could also choose to cover the test if it were to be approved.
At the meeting, Grail executives emphasized that the test produced a low false-positive rate and that a majority of the cancers it detected were at Stage 1, 2 or 3. The company also said the test detected cancers for which there is no current guideline-recommended screening, such as liver and pancreatic cancer.
But F.D.A. representatives noted at the meeting that, across both the U.K. trial and a U.S. study, the test only detected one out of every three cancers diagnosed by doctors within a 12-month period.
“That’s not as good as a coin toss,” Diana Zuckerman, the president of the National Center for Health Research, a nonprofit health policy research group, said in a public comment session during the meeting.
The detection rate was higher among more advanced cancers.
Philip Castle, the director of the cancer prevention division at the N.C.I., said during the meeting that the test’s ability to detect cancers in the early stages, “where intervention matters the most, remains poor.”
Beyond the questions of efficacy, experts have warned of other risks, including that the test could lead to overdiagnosis, which occurs when screening detects cancers that may be slow-growing or not aggressive enough to cause symptoms. This can create costs for patients and the health system without delivering any clear benefit.
They have also expressed concern that false-positive results could lead to anxiety and distress among patients.
F.D.A. representatives, panelists and members of the public also said at the meeting they were worried that patients who receive negative results may forgo evidence-based cancer screenings like mammograms or colonoscopies — even if the test labeling indicates that they should continue.
“When they start having symptoms, there will be a tendency to avoid going to the doctor, just delaying a little bit,” Dr. Zuckerman said. “And that could be deadly.”
The panelists appeared to be swayed by the findings that the test detected cancers that don’t have routine screenings, though they acknowledged that the clinical benefit of that detection remained unknown. They also cited the low rate of false-positive results and small number of invasive procedures performed among those patients as favorable safety signs.
But the panelists generally concurred that they couldn’t confidently say Galleri could be described as an “early” detection test, and a number of them said that without data on patients’ clinical outcomes, they couldn’t be sure of the test’s effectiveness.
“As an oncologist, I generally look at that as outcomes, and we don’t have that data,” said Dr. Stanley Lipkowitz, chief of the women’s malignancies branch at the N.C.I. and a member of the panel.
“If we approve this without that,” he added, “all the subsequent tests won’t need that either. We need to set the bar here higher because it is the first one.”
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