FDA Approves Direct-to-Consumer Cancer Mutation Test

The FDA announced it will allow the genetic testing company 23and Me to market directly its breast cancer test that will help assess 3 mutations in a common form of breast cancer gene

In a statement, the FDA said that the three mutations 23andMe's test evaluates are BRCA1/2 variants that occur most commonly in people of Ashkenazi Jewish descent.

What it does: The test, which will be available through 23andMe's $199 health and ancestry service, reports three genetic variants found on the BRCA1 and BRCA2 genes that are most common in people of Ashkenazi Jewish descent.

The FDA today granted authorization for a direct-to-consumer test for a highly selected group of cancer-associated BRCA mutations.

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23andMe previously included breast cancer risk in its genetic tests in the US, but stopped in 2013 after the FDA sent the company a warning letter stating the company was marketing its test without approval. "This means a negative result does not rule out the possibility that an individual carries other BRCA mutations that increase cancer risk".

But "it has a lot of caveats", warned Donald St. Pierre, acting director of the FDA's Office of In Vitro Diagnostics and Radiological Health. Now they can add information about three BRCA mutations to the health reports they issue. In addition to testing, it is important for patients to discuss cancer risk related to lifestyle factors with their providers, according to the release.

The FDA stresses that despite approving this first-of-its-kind test, the fact is that it only detects three out of 1,000 DNA abnormalities which can lead to cancer, so it shouldn't replace regular mammogram tests or trips to the doctor. The agency also noted that a majority of cancers are caused by lifestyle factors, such as smoking, obesity, hormones, and other habits. The manufacturer also submitted data on user comprehension, which showed instructions and reports were easily understood. The test was reviewed through the de novo premarket review pathway. These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for this test. As with the first 10 tests, the company is authorized to provide the results directly to the customer.

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