An advisory panel for the U.S. Food and Drug Administration on Wednesday recommended the approval of a blood test designed to detect various cancers in their early stages.
The test, manufactured by Grail and called Galleri, does not diagnose cancer, The New York Times reported. However, by using a single blood draw, the test looks for a signal for the early detections of a long list of tumors, according to The Associated Press.
The FDA panel voted 7-2, with one abstention, to approve a premarket approval application for Galleri, The Wall Street Journal reported.
The vote followed two earlier votes, where experts affirmed that the test appears safe and effective for use by people age 50 and older, the AP reported.
Critics of the test, including oncologists and screening experts, have expressed skepticism, stating that Grail’s test has not been shown to reduce cancer deaths, according to the Times. They added that possible risks, including potential harm to patients and increased health care costs, could outweigh any potential benefits.
The test works by analyzing DNA fragments in the blood for certain patterns that would indicate cancer, according to the newspaper. It has been available to people in the United States since 2021 through a regulatory exception.
When a cancer signal is detected, Galleri is designed to predict the cancer signal origin with high accuracy to help guide diagnostic evaluation, The Wall Street Journal reported.
The newspaper added that the test is intended to be used in addition to recommended screenings, and not as a replacement.
According to Grail, hundreds of thousands of people have taken a Galleri test, including 117,000 in the first half of 2026. That number does not count those who have taken the test as part of research, the Times reported.
“Perhaps my yes is a hopeful rather than an accurate one,” Victor van Berkel of UofL Physicians in Louisville, Kentucky, said, the AP reported. He added that more research was needed, even if the test gets approval from the full FDA committee.
“If we can find more early stage cancers in the population that we can’t screen for currently, that will end up having benefit,” he added.
“The Galleri test was developed to improve the effectiveness and efficiency of our national cancer screening program by adding multi-cancer early detection to recommended screening -- helping find more cancers safely, when they may be easier and less costly to treat, and it still may be possible for a patient to receive treatment with curative intent,” Josh Ofman, the CEO of Grail, said in a 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.”
Currently, most patients must pay out of pocket for Grail’s test, which has a list price of $949, the Times reported. However, Grail lobbied successfully for legislation that would authorize Medicare to cover the costs of the test beginning in 2028 if the FDA approves it, according to the newspaper.