23andMe can now sell a genetic test for breast cancer to anyone who wants one
The genetic testing company 23andMe has gotten permission from the US Food and Drug Administration to sell a test directly to customers that detects DNA mutations associated with a higher risk of several cancers.
What it does: The test, which will be available through 23andMe’s $199 health and ancestry service, reports three genetic variants of the BRCA1 and BRCA2 genes that are most common in people of Ashkenazi Jewish descent. Mutations in these genes raise a person’s risk for breast, ovarian, and prostate cancer.
Limited test: There are more than 1,000 known mutations found on BRCA genes, and 23andMe’s test doesn’t yet look at the most common ones in the general population. The FDA cautions that a negative result from the test doesn’t rule out other BRCA mutations or an increased risk of cancer.
Why it matters: In 2013, the FDA ordered 23andMe to stop marketing a health test for 250 diseases, including BRCA-related cancers, citing the potential for the results to confuse customers and possibly lead to unnecessary tests or surgery. Last year, the FDA finally gave its approval for 23andMe to market a more limited test, the first direct-to-consumer genetic test for health risks.