23andMe’s CEO on the Struggle to Get Over Regulatory Hurdles

In 2013 the genetic testing firm 23andMe received a cease-and-desist letter from the U.S. Food and Drug Administration forbidding it from selling its spit-in-a-tube DNA test to consumers. Since its founding, six years earlier, 23andMe had operated in a murky space: Previously, genetic tests were ordered only by doctors, and it was unclear whether the device the company sold to consumers to facilitate testing constituted a “medical device.” Over the next two years, while it continued to sell tests giving consumers information about their ancestry and ethnic origins, 23andMe had to work with the FDA to gain regulatory approval for its consumer health product. This required the company to prove not only that the test was valid but also that test results could be understood by untrained consumers. CEO Anne Wojcicki writes that the process helped her recognize an element of Silicon Valley arrogance in how the company had previously dealt with regulators, and helped 23andMe improve its product and become more resilient.