23andMe to Follow FDA Order, Halt Test Sales

By Wire Reports and NBC10.com Staff
|  Friday, Dec 6, 2013  |  Updated 1:46 PM EDT
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The company 23andMe will halt the sales of their genetic test that use saliva to determine their chances of getting certain diseases.

NBC10

The company 23andMe will halt the sales of their genetic test that use saliva to determine their chances of getting certain diseases.

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Genetic testing company 23andMe Inc. will comply with a Food and Drug Administration directive to stop selling health-related genetic tests during a regulatory review.

In a message on its website Thursday, the Mountain View, Calif. company said that it will continue to provide ancestry-related information to customers and raw genetic data without interpretation. Customers who bought kits since the FDA order came out last month will be eligible for refunds.

“We remain firmly committed to fulfilling our long-term mission to help people everywhere have access to their own genetic data and have the ability to use that information to improve their lives,” said the statement.

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FDA representatives did not immediately return a phone call from The Associated Press seeking comment on the company's announcement.

23andMe's saliva-based test kit, launched more than 5 years ago, claims to tell customers if they are at risk for more than 250 diseases and health conditions. The FDA says only medical tests that have been cleared by the government are permitted to make such claims.

Last month, the agency had ordered 23andMe to stop marketing its test, warning that erroneous results could cause customers to seek unnecessary or ineffective medical care.  The FDA warning letter stated that even after numerous meetings and email exchanges with the company, the agency still had no assurance that the firm has analytically or clinically validated its technology.

23andMe sells its tests online. Customers receive a small tube in the mail, which they return to the company with a saliva sample for DNA analysis.

The company was co-founded by Anne Wojcicki, who recently separated from her husband, Google co-founder Sergey Brin. Both Google and Brin have invested millions in the privately held company over the years.
 

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