FDA clears DNA test to spot cancer genes, but with warnings
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March 7, 2018
WASHINGTON (AP) — U.S. regulators have approved the first direct-to-consumer breast cancer gene test.
But the Food and Drug Administration said Tuesday it will require warnings about the limitations of the genetic information from California-based 23andMe.
The test, which analyzes DNA from saliva, can only detect three out of more than 1,000 known inherited BRCA gene mutations. It cannot determine a person's overall risk of developing cancer.
The FDA says the test is not a substitute for regular medical checkups and should not be used to make any medical decisions. Most cancers are not ca...
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