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 caused...