AUSTIN, Texas — Imagine a world in which everyone is empowered to take charge of their own health care by discovering their personal genetic risk factors. That's the vision of Anne Wojcicki, founder and CEO of the personalized gene-testing company 23andMe.
"How many people love the health care they're getting today?" Wojcicki asked a large audience here Sunday (March 9) at the South By Southwest Interactive festival. Only a handful of people raised their hands.
The problem with health care, Wojcicki said, is health care companies' huge financial incentive for sickness. Before founding 23andMe, Wojcicki worked in health care investment, where she would give talks about how to profit from obesity. On the other hand, Wojcicki said, "Who makes money off me not getting sick?"
23andMe's aim is to change health care by empowering people to own the information that may affect their health, Wojcicki said. If people know their personal genetic risk factors, it can help them make better decisions and lead healthier lives, she said. [7 Diseases You Can Learn About from a Genetic Test]
In November 2013, the U.S. Food and Drug Administration sent a letter to 23andMe, telling the company to stop marketing its DNA testing kits because the company had not received the agency's medical device approval. Along with its test results, 23andMe provides information to customers about their risk of developing certain diseases or hereditary conditions, and the FDA expressed concern that customers would make major health care decisions based on limited information.
When asked, Wojcicki said the FDA ruling was having a significant impact on 23andMe, slowing the number of people signing up for its test kits. But she noted that the company already has 650,000 people in its database, and is still receiving requests for testing from academic and foreign partners.
Her company will have some challenges to overcome, Wojcicki said, including working toward FDA approval for its tests.
The FDA decision has sparked debate in the medical community. Dr. Samuel Volchenboum, a pediatric oncologist at the University of Chicago, also spoke here on Sunday, and said the FDA's targeting of 23andMe is ultimately hurting consumers.
Some say the FDA overstepped its mandate to advance public health, by hampering innovation rather than promoting it, Volchenboum said.
Personal genetic testing raises ethical and legal questions, Volchenboum said. For instance, should parents be allowed to test their children? Should people be required to find out all of their results? And should customers be required to inform family members of their results? But the FDA didn't ask these questions, Volchenboum said.
The fight between 23andMe and the FDA is just the tip of the iceberg, he said. "I think we're going to see lots [more] of these cases coming up."