FDA panel narrowly backs multi-cancer blood test despite doubts it works
A blood test that aims to catch more than 50 types of cancer before symptoms appear narrowly won the backing of U.S. Food and Drug Administration (FDA) advisers Wednesday, even as several doubted it works.
On Wednesday, a U.S. Food and Drug Administration (FDA) advisory committee approved a multi-cancer blood test, Galleri, despite some doubts about its effectiveness. The test, developed by Grail, looks for DNA in the blood that may indicate cancer. Galleri can detect cancers such as those of the stomach, bladder, colon, skin, and breast, among others. The test costs nearly $1,000 and has been available in the United States since 2021 without FDA approval.
The FDA's 10-member advisory committee voted 6-4 in favor of Galleri, with one member abstaining. All members agreed that the test is safe, but some had reservations about its benefits outweighing the risks. Dr. Victor van Berkel, a committee member, noted that finding early-stage cancers in unscreened populations could be beneficial. However, he acknowledged that this has yet to be proven.
A trial involving over 140,000 people in England did not reduce the rate of late-stage cancer diagnoses across 12 types of cancer. Grail had announced earlier in the year that the trial did not achieve its main goal. However, a study published in Nature Medicine by Grail-funded researchers found that about 6 in 10 people with a positive test result actually had cancer. More than half of the new cancers detected by the test were early-stage and were types that do not have routine screening.
Experts, including Dr. William Dahut from the American Cancer Society, argued that testing for multiple cancers simultaneously is more efficient than developing separate tests for each one. Dr. Emil Lou, an oncologist, warned that the test can produce false alarms, leading to stress and unnecessary procedures, as well as missing actual cancers, which may provide false reassurance.
Dr. Scott Ramsey, a researcher, questioned whether the test would ultimately reduce the risk of dying from cancer, stating that a negative result should not lead people to feel reassured and continue with proven cancer screenings. Grail's proposed label clarifies that a negative result does not rule out cancer, a positive result requires follow-up testing, and the test is not a diagnosis.
The FDA typically follows its advisory committee's recommendations but may make its own decision. Grail expects a final approval decision in the coming months.
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