23andMe receives limited approval from FDA to work in US

By David Curry October 23, 2015

23andme returns to america kit — Image used with permission by copyright holder

23andMe has received limited approval from the Food and Drug Administration (FDA) to start offering its health screening tool in the country. The approval comes two years after the genetics testing firm were removed from the American market, due to apparent accuracy and interpretation concerns.

23andMe will be able to offer 35 of the 250 tests inside of the United States. Information on Alzheimer’s and Parkinson’s diseases, which shows if your genetics have any signs of picking up the disease, will still be unavailable. The company has not said if it plans to push the FDA to approve more of the tests in the near future.

“We took a lot of the feedback that we’d gotten over the last seven years and then incorporated that with all the FDA feedback into a whole new report format,” chief executive Susan Wojcicki said in an interview.

23andMe arrived in the United States in 2006 with quite a few celebrity endorsements, but the FDA and other medical departments found the unregulated, informal tests to be big problem. In Europe, 23andMe has been able to get past most of the regulatory departments.

Over 1 million people have bought the saliva-based test kit since launch, and more than 80 percent have allowed 23andMe to sell and share data with medical companies. 23andMe has kept going with investment from Google and a few other partners.

23andMe will sell the kit for $200 per person, double the amount it originally cost. This makes the testing kit an investment in health, rather than a free app that can detail some of your health issues.

The announcement comes as more technology companies enter the health market, including Apple’s HealthKit and ResearchKit, Google Fit, and Microsoft Health.

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