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There’s a placard in Anne Wojcicki’s office enshrining the attitude that nearly ran her company, 23andme, aground. Tucked behind a toy unicorn, the small, wood-veneered nameplate reads: “I’m CEO, bitch.”

It was with this kind of brashness that Wojcicki set out to disrupt the health-care industry in 2006. Her goal was to put sophisticated DNA analyses into the hands of consumers, giving them information about health, disease and ancestry, and allowing the company to sell access to the genetic data to fuel research. But in 2013, that vision hit a snag. Wojcicki didn’t think she needed regulatory approval to provide information about her customers’ health risks. The US Food and Drug Administration (FDA) disagreed, and ordered the company to stop.

The FDA action prompted months of soul-searching and strategizing on how to reorient the company to work with regulators. “You just accept at some point, you’re regulated, and there’s no Silicon-Valley, 24-hour, easy fix,” Wojcicki says.

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Nature News

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