23andme’s CEO Says the Company Will Win FDA Approval For More Genetics Tests
The Food and Drug Administration may have stopped genetics company 23andme from offering the battery of DNA tests that it once ran for customers who sent their saliva to Silicon Valley, but CEO Anne Wojcicki insisted on Tuesday that the old reports about genetic risks for diseases like Alzheimer’s and Parkinson’s will be coming back.
“This was like a speed bump, a big speed bump,” she said of the FDA demanding in 2013 that the company halt their genetic testing, before giving the company approval the resume a more limited array of tests in late October. The FDA cited concerns about the accuracy of 23andme results that suggested, for example, the likelihood that a customer might get breast cancer—saying a false positive might lead to something as serious as an unnecessary preventive mastectomy.
Speaking at Fortune’s Most Powerful Women Next Gen conference, Wojcicki suggested that the path she’s pursuing—allowing private companies to provide people with information about their health without necessarily involving a doctor or genetic counselor—will eventually be paved, with the help of businesses like hers that are willing to go through years of seeking approvals from regulating bodies like the FDA.
“Direct to consumer healthcare is coming,” she said. “Do you have to go to your physician for everything? Do you have to go for a blood test? Do you have to go for all your genetic information?” Wojcicki asserted that her company had already “proved” that the answers to those questions are in the negative. Theranos, another highly valued healthcare startup that has promised customers a wealth of information about their health from just a pinprick of blood, has also been restricted by the regulatory agency.
For now, 23andme is able to sell customers information about their ancestry and about whether they are genetic carriers for diseases that their children might inherit, such as cystic fibrosis. Wojcicki called this “step one” of not only a comeback, but an expansion of her business, which is venturing into drug development, armed with the genetic data her team now has on 1 million users. On Tuesday she said that while 23andme is fundamentally a direct-to-consumer company, she expects it will eventually make the lion’s share of its revenue from developing drugs more cheaply than other companies currently are.
“Anybody who has ever had a disease, you want to make a difference, you want to participate in research,” she said, hinting at the privacy concerns that many people may soon have about their DNA as genetic testing becomes more robust and common. “We have established a path forward.”