Editor's note: Inc. magazine's 2018 Company of the Year is Bird. Here, we spotlight a contender for the title.
Eighteen years ago, Julie Galassini was tested for a genetic predisposition toward breast and ovarian cancer--it came back negative, while her sisters' tests were positive. She decided to get tested again after receiving a 23andMe kit for Christmas last December, just to be sure. It was a fateful decision: She tested positive, and later learned the first testing company had mixed up her results with another patient's.
Less than a week later, Galassini was in surgery for a hysterectomy to preventatively remove her uterus. She's since had a double mastectomy. The aggressive action made sense: Her sister died of ovarian cancer in 2013, and her mother died of breast cancer two years later.
"I will honestly say," she says of the 23andMe test, "that it probably saved my life."
In 2013, sending customers this kind of potentially life-changing genetic information brought the Food and Drug Administration knocking--and 23andMe's health-testing service to a halt. The FDA insisted that the company prove its results were accurate--and that customers could easily understand them--before it could resume selling. It took almost four years, but the company finally won permission last year to tell customers their likelihood of developing Parkinson's, Alzheimer's, and a handful of other diseases. This past March, it received the first-ever FDA authorization for a direct-to-consumer genetic report for cancer.
In 2018, 23andMe emerged from its battles as a more mature, more careful, and arguably more powerful company than ever. More than 5 million customers have come for the fun ancestry test (usually $99), with many staying to take the health test (another $100). As such, 23andMe has become one of the biggest players in the genetics testing industry. And that puts the company at the heart of one of the most pressing corporate issues of the year: data privacy. You didn't think you'd be the only one who could study your results, did you?
Genetic testing grows up
Early on, the Mountain View, California startup operated with a very Silicon-Valley-esque "move fast and break things" mindset. Co-founder and CEO Anne Wojcicki now says that the company's missteps with the FDA stemmed from a lack of knowledge about how the process was supposed to work.
"We made a lot of cultural faux pas, but it wasn't with the wrong intentions," she says.
The company now must carefully prove the accuracy of each of its tests for the FDA before launching to the public. Even so, telling people their percentage likelihood of developing certain diseases remains sensitive territory.
"It's kind of circumventing a genetic counselor," says Glen Cohen, professor of health law and bioethics at Harvard Law School. "There's not someone who can help interpret the test for you and explain what it means and what it doesn't mean. That's the tension here. There are many people who could benefit from genetic testing and never get it done, so if we can democratize and expand testing, that's great. But there's this question as to whether this is the best way of doing it."
Having now genotyped the DNA of millions of customers, 23andMe has a trove of data that could be valuable in correlating gene pools with specific traits and illnesses--an especially useful tool for drug makers. That's why in July, pharma giant GlaxoSmithKline made a $300 million investment in the company in exchange for equity. GSK will also have access to the company's data.
"Part of the reason why we started 23andMe," Wojcicki says, "was that we thought we had the potential to dramatically accelerate the pace of research. Now we're able to show something truly meaningful coming out of that mission."
Still, the idea of selling customers' genetic data to a corporation has raised some eyebrows. The company's consent form has alluded to this possibility since its early days, but the GSK deal made it much more tangible. For its part, 23andMe says it anonymizes all data, though the rash of corporate leaks and hacks in recent years has shown that isn't always enough. The company gives customers the option of whether to opt in to research, which it says more than 80 percent choose to do. (Ancestry, 23andMe's chief competitor that focuses more on genealogy, engages in similar data-selling practices.)
23andMe, meanwhile, is ramping up its internal efforts to develop treatments. The company currently has a team of 60 people, led by former Genentech executive vice president Richard Scheller, dedicated to the practice. They have a particular focus on Parkinson's, thanks in part to the fact that Wojcicki's ex-husband, Google co-founder Sergey Brin, has a genetic mutation that makes him more vulnerable to it.
The company has grown to more than 600 employees--more than half of whom are women, a rare exception in the worlds of Silicon Valley and biotech. And the company's reviews on Glassdoor are overwhelmingly positive: It's earned a 4.9 out of 5.0 rating from 110 employee reviewers; 97 percent report they would recommend the company to a friend; and a full 100 percent say they approve of Wojcicki.
One big milestone the company hasn't reached yet: profitability. ?Wojcicki won't reveal the company's revenues, but she does say it's yet to cross that important threshold. Even so, 23andMe was reportedly valued at $1.75 billion during its $250 million fundraising round in 2017--which came before the GSK deal.
Of course, that's not the only goal the entrepreneur has in mind.
"I was thinking about it: When can I take a real vacation?" Wojcicki says. "I think it's when I have a series of drugs that have really impacted lives and cured people. Once I can point to meaningful impacts, that's when I'll feel good."