23andMe Tries to Woo the FDA

Anne Wojcicki bounds into a conference room in Mountain View, California, straight from a five-mile ride from home on an elliptical bike. The 40-year-old cofounder and CEO of the consumer genetic testing firm 23andMe is breathless, and not just because of the workout. On this warm day in mid-June, Wojcicki is “super-excited” about an announcement scheduled for two days hence: the Food and Drug Administration has agreed to review a health-related genetic report the company wants to make available to customers.

It’s the first step out of the FDA’s doghouse for 23andMe. For $99, the company analyzes key components of a person’s DNA from a vial of saliva, but last November the federal agency issued a testy warning letter barring it from marketing its service. The FDA said that by selling consumers a test and health reports that outlined their chances of getting dozens of diseases, plus their likely response to various drugs, 23andMe was effectively selling a medical device. That requires explicit approval—and the FDA said 23andMe hadn’t come close to providing enough evidence that its test provides accurate, reliable health assessments.

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Source: MIT Technology Review