Anne Wojcicki, chief executive of 23andMe, was at SXSW Interactive today outlining the benefits of providing individuals with their genetic markers, partnering with doctors for preventative treatments, and crowdsourcing genetic research.
But Wojcicki's appearance comes several months after the FDA ordered 23andMe to "immediately discontinue marketing" its genetic testing service, something the executive danced around during today's appearance.
The FDA classifies 23andMe's testing service as a medical product, specifically: This product is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.
Until the product gets approval, the company can no longer provide health information to consumers. "Having the FDA come and shut that down has had a significant impact on the business," Wojcicki said diplomatically.
Although the agency's crackdown has slowed sign-ups, 23andMe still has a massive database of genetic information. More than 650,000 people have spat into one of 23andme's tubes and sent their genetic material in for testing. 23andMe users have also answered more than 1.7 million questions, making it one of the largest ongoing research groups.
Wojcicki said the healthcare industry is at a turning point and the consumerisation of healthcare will go mainstream. "For the first time, people are recognising that healthcare needs to be driven by the consumer."
Giving consumers access to their genetic information can have a powerful impact on the choices people make about their healthcare. Wojcicki referenced a few 23ndMe customers who successfully identified health issues they may otherwise have missed until it was too late.
A doctor used a woman's 23andMe results to help him diagnose her stomach problems as Celiac's disease, while a father discovered he passed the gene for fructose intolerance to his son, enabling him to eliminate sugar from his son's diet and pre-empt future problems. And of course, most controversially, there are hundreds of women who have identified the BRCA marker.
"Everyone has the right to get access to their genetic information and to understand it," Wojcicki said. "It's your data, it's all about you. Individuals always have access to the raw data. You can log onto 23andme right now, download your raw data, and take it to other service."
"The most proactive thing you can do is to own your data", Wojcicki said. "I hope in 10 years we have a society where people are proactively managing their health and getting critical information that helps them avoid disease."