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23andMe Can Give Out Health Information Again After a Two-Year Ban in the US

The genetic testing company now has FDA approval to analyze DNA samples for certain diseases.
Image: 23andMe

Genetic testing company 23andMe is back in business.

The Silicon Valley company has received approval from the Food and Drug Administration to provide users with health information about certain genetic diseases. This is the first time in two years that the company, which uses saliva tests to analyze its users' DNA, has been allowed by the FDA to offer health-related information.

At the time of the ban in 2013, the FDA said 23andMe would have to prove that its test results were accurate before it could offer health-related information to US customers. 23andM3 had, in the interim, continued to provide non-medical information to customers, including genetic ancestry data. 23andMe continued to provide health-related information to customers in other countries like Canada and the UK.

The FDA is allowing 23andMe to analyze users' DNA for certain genetic diseases like cystic fibrosis and sickle cell anemia. Such information could be useful in determining if, for example, two parents are carrying genetic mutations that could be passed to their children. The company is still not allowed to tell users if they themselves may develop certain genetic diseases in the future.

23andMe founder Anne Wojcicki told the New York Times ahead of the announcement that she wanted consumers to "have a sense of ownership" about their genetic information—provided they have the $199 (up from $99) for the saliva testing kit, that is.

News that 23andMe will once again be allowed to offer health-related information comes just a few days after the company announced that it had raised $115 million in funding.