Update, 12:00 p.m. Oct 21: 23andMe relaunched its gene test with dozens of health reports, making it the first direct to consumer DNA test to gain approval from FDA.
Many media pundits wrote off a genetic-testing start-up called 23andMe in November of 2013, when federal regulators ordered an immediate halt to sales of its flagship product.
In exchange for a swab of spit, Google-funded 23andMe provided people with direct access to over 200 health reports, detailing their risk of getting or carrying the gene mutation for a disease such as breast cancer or Parkinson's disease. But regulators feared that people would misinterpret this health data, which had not been clinically validated, or take action based on a "false positive" result.
Obstacles aside, the company has continued to grow its team with some high-profile hires, ink partnerships with big pharmaceutical companies like Pfizer and expand its customer base to more than 850,000 people. All this, while it continues to work with the U.S. Food and Drug Administration (FDA) to bring its DNA test back to market.
The secret to the company's success? Its unstoppable chief executive, Anne Wojcicki, who has stayed true to the company's core mission: To improve access to the human genome.
I spoke with Wojcicki shortly after a meeting with her ever-expanding staff, and a week before a rare vacation to a remote corner of the world with her sister, Susan Wojcicki, another Silicon Valley power player who works as the CEO of YouTube. Our interview has been condensed and edited for brevity.
23andMe has certainly had its critics over the years, as it's ambitious in scope. What prompted you to start the company in the first place?
As a young analyst on Wall Street, I invested in health care companies. I loved it, but I felt conflicted. I would go to parties filled with people in health care, and it was all about making money and having fun. I was also volunteering at hospitals in my spare time. I noticed this disconnect between the world that was making money on health care and those who are using it.
I still cringe at the U.S. health care system that is focused on optimizing revenues, versus improving access to care. I wanted to democratize access and I also knew that very little money was spent on prevention. 23andMe is focused on showing people their health risks. If I can do that, I think I'm doing a great service.
What are some of the most eye-opening discoveries you've made by using your own service?
I remember the first time my family took the test, because we found out that Sergey [Brin, cofounder of Google and Wojcicki's husband] was a carrier for the LRRK2 gene, making him a carrier for Parkinson's Disease. That was monumental. We also found out that I have a higher risk for breast cancer and I'm a carrier of an inherited disease called Bloom's Syndrome. I am now more proactive about my diet.
Another cool thing is the first time you see that your children are actually our children. Obviously I know they're mine as I saw them being born. But when you can see it in a digital form, it's pretty awesome. It's one of those moments where you feel like you're part of this legacy.
[Editors' Note: Wojcicki is still legally married to Google cofounder Sergey Brin, but the pair are separated. Google invested $3.9 million in 23andMe in 2007.]
Were you surprised by the FDA's warning letter? Or did you expect to overcome some major hurdles with this company?
When I worked on Wall Street, we knew that stocks would go up and go down. Likewise, we have always anticipated that there would be ups and downs with an ambitious company like this, which is focused on helping people understand, access and benefit from the human genome. The FDA letter was obviously a big bump in the road for us, but our board and our investors understood from the beginning that it wasn't going to be easy.
You recently experienced a small victory, with the FDA approving your test for a rare genetic disease called Bloom Syndrome. How did you feel when you heard the news?
It was one of the first times in the company that we had a standing ovation. We felt a ton of pride. On a personal level, this has been a big lesson. There is a level of steps and patience that is required. I'm trying not to inhale the health revolution all at once.
I also felt fortunate to have Kathy Hibbs [23andMe's chief legal and regulatory officer] on board. We understood even back in 2010 that we would be regulated as a medical device. But there was a lot of miscommunication on our behalf. With Kathy, we have someone who has paved the way towards getting the product to market.
What's next in the pipeline for approval after Bloom Syndrome?
I'm playing the role of the obedient CEO and deferring to Kathy [Hibbs] on this. With the Bloom Syndrome approval, the FDA down-classified autosomal recessive disorders. We're pretty excited about that. We are also looking at pharmacogenetics [how individuals respond to drugs]; the BRCA gene test for breast cancer and disease risks, including Alzheimer's Disease.
A recent Washington Post article described you as being on the "charm offensive" in D.C., as you have been seen liaising with folks from the White House and other federal agencies. Why the shift in focus?
One of the benefits of the warning letter from the FDA is that it brought me to D.C. often for conversations with policymakers. We weren't in D.C. enough before.
23andMe is now seen in D.C. as a poster child for this "consumer empowerment" movement, as we've spoken out publicly on this topic. I've said many times that consumers with no background in medicine can understand complicated ideas. We're seeing this idea circulate on the Hill that it's the right time for the consumer to transition from subject to participant.
We've heard your name in association with the President's "Precision Medicine" initiative. How involved have you been?
We are not that involved, but I have been super impressed with the initiative so far. They called out the fact that there should be far more consumer engagement in health care. For example, why hasn't there been a single federally funded study where consumers get their genetic information? All this money is going into research, but participants aren't getting their data back.
I saw Eric Green [director of the National Human Genome Research Institute] last night. There is definitely a vision in the government to get a larger number of people engaged and leverage a lot of data. They have to put together a plan for the initiative soon. I feel lucky I'm not part of it. It's going to be a lot of work over the next three months.
You've been partnering up with big pharmaceutical vendors and other stakeholders. How can we be sure that you won't detract from the core mission, and end up like the money-guzzling entities you encountered on Wall Street?
Pharma isn't all bad. It's a necessary component of the health care system. They are the ones who make the therapies. But I do want us to do things differently in making sure the consumer is part of the solution, and we also want to continue to do work on prevention. I'm also keeping an eye on different health care models in other parts of the world, which I feel morally better about.
23andMe is getting into drug invention, which seems very ambitious given the high costs of bringing a new pharmaceutical to market. How will you find the resources?
We're going to do it differently. I find it outright crazy that so few firms are researching who this drug will work for. We want to do the right thing even if it means cutting down our market size.
There are so many inefficiencies in drug development and we'll take a different approach in clinical trial recruitment. We have almost a million people and growing, and we'll recruit directly from our database. As for the money, it will be solvable if we get to that point. We'll raise the funds if we have good target ideas.
What's next for the future? How about sequencing the whole genome, given the recent claims that it can be done for $1000?
We are definitely thinking about sequencing. It's high on our list of priorities and topics. We've always said we'll move into it when it finally gets to an even more consumer-friendly price point.
Finally, KQED's Future of You published some findings on the lack of gender diversity in health care. Any advice for would-be female founders?
There's men, there's women and then there's assholes. I recommend trying to work with the men and the women! On a more serious note though, there should be more women in the industry. Gender diversity leads to more innovation for the entire sector.