23andMe stops giving health analysis to new customers

Google-backed startup halts results in compliance with FDA demands but will continue to provide health-related information to customers who purchased the kits before the order was issued.

Genetic-testing startup 23andMe announced Thursday that it will cease giving health analysis information to new customers in compliance with demands made by the US Food and Drug Administration but will not cease sales of the kits.

The FDA issued the Google-backed startup a warning two weeks ago that demanded the company stop selling its at-home testing kits "immediately" because they required regulatory clearance and were supposedly being sold in violation of the Food, Drug, and Cosmetic Act. In response, the company halted its advertising campaigns for its popular at-home testing kits.

The Mountain View, Calif., startup said it would cease giving new customers analysis of genetic health information, but not ancestry information during the regulatory approval process. However, it will continue to provide access to information for customers who purchased their kits before November 22, the date it received the FDA order.

"We are continuing to provide you with both ancestry-related genetic tests and raw genetic data, without 23andMe's interpretation," the company said in a statement posted to its Web site.

After originally defying the FDA order, company founder and CEO Anne Wojcicki -- wife of Google co-founder Sergey Brin -- wrote in a company blog post late last month that 23andMe was working to convince the FDA of the "quality of our data" and that it was in dialogue with the agency -- albeit somewhat behind in responding to its requests.

Updated at 9 p.m. PT to correct that the company has not ceased sales of the testing kits.

 

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