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.