FDA to 23andMe: Stop Selling Genetic Tests

By ABC News

Nov 26, 2013 11:27am
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The FDA has ordered genetic testing website 23andMe to stop selling tests. (Credit: 23andMe/YouTube/ABC News)


Even Oprah has tried a genetic test from 23andMe — and it told her she was 3 percent East Asian.

“East Asian?!” She exclaimed on the PBS show “African American Lives.”

But now the Food and Drug Administration has told the online company to stop selling its $99 home saliva tests because the company hasn’t submitted scientific evidence to the FDA to prove that the tests work. In its warning letter to 23andMe, the FDA cited concerns that false positives or negatives could have serious health consequences.

The company is run by Anne Wojcicki, who is in the middle of a separation with husband and Google co-founder Sergey Brin. Google backed the start-up.

When Good Morning America interviewed Wojcicki in 2009, she told them the test would prove whether people are at risk for up to 250 different conditions, from lactose intolerance to Parkinson’s disease.

“If our son does find out that he is predisposed to Parkinson’s, he can be in a position to do something for it,” she said.

When ABC News reached out to the company this week, they issued the following statement: “Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.”

 

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