WASHINGTON (AP) — Federal health advisers on Wednesday endorsed a blood test designed to spot signs of various cancers in apparently healthy people while warning that it's far from clear how well it works.
Grail Inc.’s Galleri test doesn't diagnose cancer but instead, with a single blood draw, looks for a signal that someone may have one of a long list of tumors. They'll need additional care to tell if they're really sick.
The Food and Drug Administration's advisory panel voted 7-2, with one abstention, that the DNA-based test offers more potential benefits than risks, such as causing false assurances or raising false alarms, despite the many questions it still wants studied. The vote followed two earlier votes that the test appeared safe and effective for use by people age 50 and older.
Lots of companies are studying such blood tests and Wednesday's vote marks the first time a federal advisory group has backed the experimental approach. The FDA isn't bound by the advice but if it agrees, it could pave the way for widespread U.S. adoption of a long-sought new way to find more cancers earlier. Today there are a handful of recommended cancer screenings, such as mammograms and colonoscopies, that look for one kind of tumor at a time.
A final decision is expected in a few months.
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