Two years after being cast into regulatory purgatory by the Food and Drug Administration, 23andMe is clawing its way back. On Wednesday, the genetic testing company announced it has secured FDA approval to tell its customers whether they are carriers for a range of genetically-transmitted diseases, including Tay-Sachs and cystic fibrosis.
The deal with the agency stops well short of the company's full vision, which is to allow consumers to learn how their genes affect every area of their health, including their susceptibility to common diseases like cancer, diabetes, and Alzheimer's, without having to go through doctors. But it's a big step forward. Since the FDA warned 23andMe in November 2013 that its "spit kit" tests constituted unregulated medical devices, the company has been mostly limited to offering consumers information about their ancestry and the chance to volunteer their DNA for scientific research.
When I interviewed Anne Wojcicki, 23andMe's founder and CEO, for our Most Innovative Women Entrepreneurs issue last summer, she told me how she reacted to the FDA's crackdown: by gathering vast amounts of information, consulting closely with the agency on next steps, and accelerating partnerships with pharmaceutical companies, which are interested in using 23andMe's vast database of DNA and personal health histories to develop new therapeutic agents.
In February 2015, 23andMe got approval from the FDA to tell customers whether they are carriers for Bloom syndrome, a genetic disease. That deal provided the blueprint for today's expansion of product offerings. With the company once again able to provide meaningful health information to its users, it's raising the price of a test from $99 to $199.
Operating in a heavily regulated industry forces 23andMe to take a more incremental approach than most Silicon Valley startups, one certainly more incremental than what Wojcicki first envisioned. But she remains adamant that patients, not doctors, will be in complete command of their health data sooner than later. "I'm not daunted by the fact that there's a really entrenched infrastructure that's got to change," she told me. "I can see a vision for the next 20 years of how consumers will change healthcare and I'm really excited by that."
23andMe's comeback moment arrives just as Theranos, another innovative health-testing company based in Silicon Valley and headed by a celebrated woman entrepreneur, is navigating its own regulatory and legal roadblocks. Following a damaging report in The Wall Street Journal that questioned the validity of Theranos's technology, the company has suspended most of its testing services while the FDA sorts out the facts.