Two years after the FDA cracked down, the Silicon Valley startup is reinstating the health portion of its direct-to-consumer tests.
23andMe CEO Anne Wojcicki in 2014.
(Stephen Lam / Reuters)
In November 2013, 23andMe suffered a devastating blow: The Food and Drug Administration (FDA) forbade the DNA-testing company from providing health-related information on the basis of its genome scan, a fundamental part of its business. Nearly two years later, the Silicon Valley startup is making a comeback with a slimmed-down version of that service, this time with regulatory approval.
New and existing consumers will gain access to the retooled service in the coming months, 23andMe said Tuesday. "It's the rebirth of direct-to-consumer genetics," Emily Drabant Conley, vice president of business development and life sciences, told BuzzFeed News.
Rebirth is certainly a good word for it. While 23andMe's first DNA spit kit tested for more than 200 diseases, traits, and health conditions, the company's new one tests for 36 genetic variants associated with diseases like cystic fibrosis, sickle cell anemia, and Bloom syndrome. (These tests are typically for people who display no symptoms for a genetic disorder, but may be at risk for passing it on to their children.) And at $199 it's twice the price. But when it goes live in the next few months, it will be the first and only test of its kind that doesn't require authorization from an intermediary like a doctor or genetic counselor.
23andMe
Customers who pay for 23andMe's test can log on to the website to see how they've tested for a particular variant and view more detailed breakdowns about their results and relevant research, in addition to links to genetic counselors and disease advocacy groups. They can also find out about roughly two dozen genetically influenced wellness factors and physical traits, like lactose intolerance, eye color, and earwax type. And they can continue to learn about their ancestry composition, now with features that make it easier to build a family tree and chat with relatives.
These results will first become available to people who buy tests now (it takes four to six weeks to analyze the samples). Current customers will start being upgraded in the next few months.
Much has changed at 23andMe since late 2013, when the FDA ordered the company to stop selling its health reports. "At the beginning, we were speaking a different language from the FDA," president Andy Page told BuzzFeed News. "We didn't really have the skill set internally to interpret the many communications that came from the FDA. We made mistakes with respect to the regulatory environment and the medical community."
Since then, Page said, the company has brought on executives with more regulatory experience; 75% of the senior leadership is different overall. Under the FDA's guidance, 23andMe executives say they tested the new service on thousands of people to make sure it was understandable.
In the meantime, 23andMe sought other sources of revenue, too. It expanded into the United Kingdom and Canada, and genotyped more than 1 million people. It struck deals with Genentech and Pfizer to open up access to its database (80% of 23andMe's customers let their data be used for research). The company also announced plans to become a pharmaceutical company itself with a 20-person team led by a former Genentech executive. This month, it raised $115 million at a reported valuation of $1.1 billion.
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