23andMe Gains FDA Approval for DTC Test

23andMe and the U.S. Food and Drug Administration (FDA) announced this month that the agency allowed marketing of 23andMe's Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. "These are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information on an individual's genetic predisposition to certain medical diseases or conditions, which may help to make decisions about lifestyle choices or to inform discussions with a health care professional," said the FDA in its statement.

In 2013, the FDA issued a warning letter to 23andMe requiring that it stop marketing its DTC Personal Genome Service. The FDA had concluded that the $99 saliva test was a class III medical device requiring FDA approval. But a little less than two years later, the company won FDA approval for a DTC genetic carrier test for Bloom Syndrome.

Now, the FDA has given 23andMe authority to market its DTC genetic testing report that indicates personal risk for certain diseases such as late-onset Alzheimer's, Parkinson's, and celiac. The approval was granted following de novo classification review—which can be used for low or moderate risk devices that are not substantially equivalent to existing devices. Tests reviewed under this approach will be subject to special controls regarding the test's "accuracy, reliability and clinical relevance." Future tests that are substantially equivalent to this DTC test will be able to utilize the 510(k) approval process.

"This is an important moment for people who want to know their genetic health risks and be more proactive about their health," declared 23andMe CEO and Co-founder Anne Wojcicki in a statement. "The FDA has embraced innovation and has empowered individuals by authorizing direct access to this information. It is a significant step forward for 23andMe and for the adoption of personal genetics."