23andMe Wins FDA Approval for Direct-to-Consumer Cancer Test

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Tuesday, March 6, 2018

The U.S. Food and Drug Administration (FDA) today authorized the first direct-to-consumer (DTC) test to report on three specific BRCA1/BRCA2 breast cancer gene mutations that are most common in people of Ashkenazi (Eastern European) Jewish descent. These three mutations, however, are not the most common BRCA1/BRCA2 mutations in the general population. “This test provides information to certain individuals who may be at increased breast, ovarian or prostate cancer risk and who might not otherwise get genetic screening, and is a step forward in the availability of DTC genetic tests. But it has a lot of caveats,” said FDA spokesperson Donald St. Pierre. “While the detection of a BRCA mutation on this test does indicate an increased risk, only a small percentage of Americans carry one of these three mutations and most BRCA mutations that increase an individual’s risk are not detected by this test. The test should not be used as a substitute for seeing your doctor for cancer screenings or counseling on genetic and lifestyle factors that can increase or decrease cancer risk.” After an FDA review determined that the test is accurate (i.e., can correctly identify the three genetic variants in saliva samples) and can provide reproducible results, marketing authorization was granted to 23andMe. Learn more here