Watch: 23andMe CEO addresses FDA setback

December 6, 2013: 11:37 AM ET

"We're kind of a square peg in a round hole" Wojcicki says in exclusive interview

On November 22, the FDA sent 23andMe a letter saying that the company did not have approval to market its product as a medical device. The company sells DNA Spit Kits for $99, which are then mailed back to 23andMe and used to sequence part of a customer's genome. 23andMe has since stopped marketing the kits and yesterday announced it would no longer provide heath data to new customers, while the company undergoes a regulatory review process.

As company co-founder and CEO Anne Wojcicki says in the above interview with Fortune senior editor-at-large Patricia Sellers—the first and so far only interview in which she addresses the FDA's charges—"We have to solve the problem."

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