23andMe CEO defends company in response to FDA letter

Source: 23andMe

Anne Wojcicki, co-founder of $99 DNA testing service 23andMe, countered a warning letter issued by the Food and Drug Administration demanding the company "immediately discontinue marketing" its DNA testing kit.

"We stand behind the data that we return to customers—but we recognize that the FDA needs to be convinced of the quality of our data as well," Wojcicki said in a blog post on the company's website Tuesday night.

On Nov. 22 the FDA ordered 23andMe to halt marketing of its genetic testing device, expressing concern that it could return inaccurate results and lead consumers to undergo unnecessary health procedures.

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Good genes

Wojcicki said her company has worked extensively with lab partners to ensure that all testing results are accurate, but she acknowledged that the company was "behind schedule" in responding to the FDA's request for more information, which resulted in the product's lack of marketing clearance.

"This is new territory for both for 23andMe and the FDA," Wojcicki said. "This makes the regulatory process with the FDA important because the work we are doing with the agency will help lay the groundwork for what other companies in this new industry do in the future."

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Wojcicki, who recently separated from Google co-founder Sergey Brin, co-founded 23andMe in 2006. Google is an investor in the company.

The FDA gave the company 15 working days to respond to its letter and outline the steps it is taking to address the agency's concerns.

—By CNBC's Karma Allen