WASHINGTON — 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 caused by genetic mutations, and the ones tracked by the test aren’t the most common BRCA mutations.
The FDA blocked 23andMe from offering genetic health information in 2013. The company has gradually won clearance to reintroduce some testing services.