After spending seven months in the Food & Drug Administration’s penalty box, the consumer genetics testing firm 23andMe recently submitted a new health-related test for FDA approval.
It was a significant step following last November’s FDA slapdown of 23andMe’s genetic tests, which included health reports outlining customers’ chances of getting a wide variety of diseases from celiac to melanoma. In a sharply worded warning letter, the FDA said the $99 tests, analyzed from a vial of customers’ saliva, constituted a medical device under its regulations, and the company needed to get explicit approval for providing risks of getting specific diseases.
Although the partly Google-funded company continued selling the tests along with ancestry data, there’s no guarantee that it will be able to resume offering even a few health reports. And even if it does, the FDA’s approval process likely will take many months. But the new submission is a sign that CEO and cofounder Anne Wojcicki is continuing her drive to reinvent healthcare by putting more information, in 23andMe’s case genetic makeup and its impact on diseases and other conditions, directly into the hands of consumers.
Specifically, she aims to speed up medical research by creating a research portal with genetic data combined with surveys it does with customers to give researchers a much easier way to see what genetic variants are associated with what diseases. With this sort of Google for genetics, pharmaceutical companies might be able to create treatments much faster. The company is already teaming with pharma companies on such research, such as an agreement announced Aug. 12 with Pfizer to research potential genetic factors associated with inflammatory bowel disease.
For a recent story on 23andMe’s attempt to get back on track, I talked with Wojcicki twice, most recently in mid-June, just as the company was preparing to submit a new health report on Bloom syndrome for FDA approval. Winded after she rode an ElliptiGO bike five miles into the company’s office in Mountain View near Google, she explained how she intends to get FDA approval and move ahead on what she says is a 10-year goal of revolutionizing healthcare. Following is an edited version of the conversations, which covered the company’s strategy for FDA approval, 23andMe’s business model, Wojcicki’s longer-term goals, and the challenges she faces.
Q: You’ve been talking more publicly of late than you had in months past, and you haven’t toned down your critique of the medical establishment. What should we read into that?
A: I still think the medical establishment has a lot of problems. Not much has changed. So we made a very conscious choice that we are going for change. It’s expensive. We have a high burn rate and our sales have been hit. But we’re sticking to it. We need to comply with the FDA and we need to show them validity.
Q: What’s the status with the FDA right now?
A: They’re a very willing partner. We are extremely lucky in the sense that when we call them, they call us right back. I think that they genuinely want to make this all work. I really do believe there’s that genuine partnership with them.
[FDA Commissioner] Peggy Hamburg wrote in a New York Times [opinion piece] that the FDA is committed to finding a path to direct-to-consumer [genetic tests]. I do believe there is a genuine intention to try to find a path. It’s probably not going to be exactly what we wanted and it’s going to take time. In Silicon Valley, you want things done instantly. It’s not going to be that. But we’ve learned that. We’re going to figure out some kind of path.
Q: What was the problem with simply applying for approval in the first place?
A: We’ve been very clear from Day One that we’re a little bit of a square peg in a round hole.