Google-backed startup halts sales in compliance with FDA demands but will continue to provide health-related information to customers who purchased the kits before the order was issued. December 5, 2013 7:37 PM PST Genetic-testing startup 23andMe announced Thursday that it will cease sales of its genetic sequencing testing kits to comply with demands made by the US Food and Drug Administration. The FDA issued the Google-back 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 was suspending sales of the genetic kits during the regulatory approval process but would continue to provide access to information for customers who purchased their kits before November 22, the date it received the FDA order Related stories Sergey Brin offers $1 million to charity -- if tech titans match 23andMe launches breast cancer networking project "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 late last month that the company was working to convince the FDA of the "quality of our data" and that it was in dialog with the agency -- albeit somewhat behind in responding to its requests.
Google-backed startup halts sales 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 sales of its genetic sequencing testing kits to comply with demands made by the US Food and Drug Administration.
The FDA issued the Google-back 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 was suspending sales of the genetic kits during the regulatory approval process but would continue to provide access to information for customers who purchased their kits before November 22, the date it received the FDA order
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"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 late last month that the company was working to convince the FDA of the "quality of our data" and that it was in dialog with the agency -- albeit somewhat behind in responding to its requests.
