FDA Authorizes First Direct-to-Consumer BRCA Mutation Test


Federal regulators have approved the first direct-to-consumer genetic test for breast, ovarian and prostate cancer risks.

The authorisation allows 23andMe to provide customers with information on three genetic variants known to be associated with a risk for breast, ovarian, and prostate cancer.

Audio will be available later today. The FDA cautions that a negative result from the test doesn't rule out that a person has other BRCA mutations or an increased risk of cancer. But they're most common among people of Eastern European Jewish descent.

Still, the company, which already tests DNA for other health risks as well as ancestry, said this cancer test is "a step in the right direction".

Things changed in a big way in 2017 when the FDA authorized 23andMe to provide direct-to-consumer DNA testing for 10 conditions like celiac disease, Parkinson's, Alzheimer's, and more. Due to the mentioned caveats, the agency indicated that patients should not exclusively rely on this test, nor should the test be used to determine a cancer treatment. Results also should not be used to guide treatment such as surgery or hormones, the FDA said. The variants are found most commonly in people of Ashkenazi Jewish descent - they are "not the most common BRCA1/BRCA2 mutations in the general population", the FDA said in a statement. "Together, BRCA1 and BRCA2 mutations account for about 20 to 25 percent of hereditary breast cancers and about 5 to 10 percent of all breast cancers", the National Cancer Institute says. The company submitted data on user comprehension studies, using representative GHR test reports, that showed instructions and reports were generally easy to follow and understood by a consumer. Along with this authorization, the FDA is establishing criteria, called special controls, which set forth the agency's expectations in assuring the test's accuracy, reproducibility, clinical performance and labeling.

Topol's warning reflects an FDA letter sent to the service back in 2013, urging 23andMe to discontinue marketing its Saliva Collection Kit and Personal Genome Service.

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