- 23andMe took the controversial approach of going directly to consumers with its health test.
- The typical model requires a doctor's prescription before administering tests.
- CEO Anne Wojcicki was committed to the idea that people should have easy access to their own health data.
For more than a decade, Anne Wojcicki had a simple goal: Give people direct access to their medical data.
Consumers have been able to digitally track and control their finances, travel and shopping since the early days of the internet. But retrieving their most sensitive health information, like whether they're at risk of cancer or could be a carrier for sickle cell anemia, requires a prescription from a doctor.
So in 2006, Wojcicki left a career in biotech investing to start 23andMe, with the goal of helping people obtain personal health data by mailing in a saliva sample.
"I was always impressed by the eagerness of individuals to learn about their health and take action," Wojcicki told CNBC. "They just needed the opportunity and time to learn and absorb."
But seven years after Wojcicki started the company, the U.S. Food and Drug Administration ordered 23andMe to cease selling and marketing its tests until it could prove their accuracy and ensure that consumers could understand the results without a doctor's involvement.
That would likely have pushed 23andMe back into the category of laboratory-developed tests, which typically are ordered by a physician on the patient's behalf. These tests, which are all designed and manufactured in a single lab, are not currently regulated by the FDA.
Wojcicki wasn't deterred. Instead of accepting the status quo, she had 23andMe's team spend years working closely with regulators to convince them that it's safe to deliver results directly to consumers. The upside, she said, was that ultimately getting the blessing of the FDA would give potential customers confidence in the quality of 23andMe's products.
It was a five-year slog, but in March of this year, 23andMe became the first company to get approval to inform women of their breast cancer risk, based on three gene mutations — all without a doctor's intervention.
"Since our earliest days, we wanted to pioneer a path where people can get their genetic information directly and do not have to go through a physician or genetic counselor for access or interpretation," Wojcicki said.
Now 23andMe — ranked No. 7 on CNBC's 2018 Disruptor list — has a $160 health and ancestry service on the market that includes reports on a user's risk of contracting breast cancer, Celiac disease, Parkinson's disease and Alzheimer's disease. For prospective parents, it can also tell them their carrier status of cystic fibrosis, sickle cell anemia, hereditary hearing loss and many other abnormalities.
"Anne has done the hardest part by pioneering the consumer genetic space pretty much alone," said Mirza Cifric, co-founder and CEO of Veritas Genetics, a genome sequencing company. "Now there is an entire new wave of companies, including us, bringing the next generation forward."
23andMe says that 5 million people have used its products. Wojcicki hopes the company's success encourages other health and diagnostics start-ups to pursue the direct-to-consumer model.
But few fledgling Silicon Valley businesses have the types of luxury that 23andMe has enjoyed since its inception.
Wojcicki's ex-husband, Google co-founder Sergey Brin, was an early backer and advocate as he personally carries the gene that increases the risk for Parkinson's disease. In 2007, Google invested several million dollars in the company, and 23andMe has consistently had access to venture capital funding, raising more than $480 million to date. Sequoia led the most recent round, of $250 million, last year.
Wojcicki said 23andMe's investors have long been unanimous in supporting a focus on the consumer, viewing that as the right way to help fix the broken health-care experience.
While working with regulators, 23andMe found other ways to generate revenue. It created a $79.20 genealogy test — a competitor to Ancestry — that informs people about their heritage, such as whether they're of African or European descent or a combination of both. That product was particularly popular over the holiday season.
The company also has two other divisions. One is a therapeutics arm that's looking for new drug targets for genetic diseases based on a database with the DNA of more than 5 million users, and the other is a research group that works with pharmaceutical companies and academic researchers to leverage genomic data in their studies. The research group has won multimillion-dollar contracts from pharmaceutical giants, like Pfizer and Genentech.
All of that potentially adds up to a wider array of consumer products to help patients manage and control their health.
"We're working to bring those discoveries directly back to our consumers," Wojcicki said.
More from CNBC Disruptor 50: