The Rise And Fall And Rise Again Of 23andMe

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Publish Date:
October 11, 2017
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Source:
Nature
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Summary

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.

Scientists, meanwhile, were dubious. Family history was and is still a more powerful indicator than genes are for predicting the risk of most diseases. “The evidence is increasingly strong that the benefits of direct-to-consumer testing for these kinds of indications are somewhere between small and zero,” says Stanford University lawyer and ethicist Hank Greely, a long-time critic of the company.

Greely says that the restrictions make sense: there is very strong evidence that genetic variants cause the ten conditions listed in the FDA’s approval in April. But the predictive value is much weaker for the variants linked to the vast majority of common health conditions that 23andme would like to tell its customers about.

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