A blood test designed to screen for dozens of cancers at once just received a major boost from a U.S. Food and Drug Administration advisory panel.
In a 7-2 vote Wednesday, the FDA advisory panel found that the DNA-based test offers more potential benefits than risks, while noting that questions about the technology still require further study.
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“Perhaps my yes is a hopeful rather than an accurate one,” one of the panelists said, according to The Associated Press. “If we can find more early-stage cancers in the population that we can’t screen for currently, that will end up having benefit.”
Despite the need for more research, the test could give doctors a new way to detect cancers that currently have no routine screening, should the FDA follow the panel’s recommendation.
The Galleri test
The Galleri test is intended for people 50 and older.
With a single blood draw, it looks for DNA signals linked to more than 50 types of cancer. If the test comes back positive, patients still need additional testing to determine whether cancer is actually present.
In a large study of more than 140,000 people, it detected about one-third of the cancers that were eventually diagnosed.
But there are limitations.
The test was much better at finding later-stage cancers than early ones, and FDA reviewers worry a negative result could give some people false reassurance and lead them to skip routine screenings. That’s why the panel backed the test as an additional option, rather than a replacement for existing cancer screenings.
What happens next
Galleri is already available in the U.S., but it’s not FDA-approved, and patients generally have to pay for it themselves. FDA approval could make insurance coverage more likely.
The FDA doesn’t have to follow the panel’s recommendation and hasn’t said when it will make a final decision.
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