Quoted: Anne Wojcicki on 23andme’s FDA problem

“For me the reaction has been full force — I need to solve the problem. It’s no different than how am I going to get my son out the door when he needs to go to school. It’s a bigger version of that same type of problem.”

Anne Wojcicki, CEO of 23andMe, on tackling the problem of an FDA order to stop selling the company’s DNA-testing kit. The agency sent a letter to the Mountain View company less than two weeks ago, saying it has failed to answer questions and concerns about the medical usefulness of the its $99 product, which is sold online. Steve Johnson wrote that the FDA also is concerned about false positives or false negatives the test might give as indicators of certain diseases.

Google Ventures-backed 23andme has been in a back-and-forth with the FDA for years, and Wojcicki admitted to Fortune that her company fell behind schedule and “failed to communicate proactively” with the agency.

“We want to work with them and we will work with them,” Wojcicki said Tuesday night at a Fortune Most Powerful Women event in San Francisco. The FDA, which sent the letter Nov. 22, gave the company 15 days to respond.

Meanwhile, the company also is facing a lawsuit, which seeks class-action status, that alleges false and misleading advertising of the testing kit to consumers.


Photo: Co-founder and CEO of 23andMe Anne Wojcicki. (Dai Sugano/Mercury News archives)


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