23andMe provides information about genetic health risks to people who buy at-home “DNA spit kits.” The company seeks to inform consumers about their susceptibility to more than 250 diseases. But the FDA now says the company hasn’t proved the tests are accurate enough, and the agency is worried Americans are relying on the results instead of visiting their doctor. The FDA exercised its jurisdiction under the Food Drug & Cosmetic Act to regulate the DNA spit kits as a genetic device used in the diagnosis or treatment of disease.
“This field of personalized medicine is really in its infancy,” said Fox, “and its terrifically exciting what we might learn one day, but its just not there yet. 23andMe hasn’t shown that their reports about your health from your genes alone are all that useful. They’re just not accurate at this time in the way that the FDA requires.”
Critics say regulators are standing in the way of consumers having the convenience of obtaining information about their own health at a reasonable price point without an expensive trip to the doctor. According to Fox, it’s a powerful argument that is often made by genetic testing companies such as 23andMe. The problem is the public’s understanding of genetics is very low. “These tests,” he argued, “come not only with limited accuracy, but also without the benefit of genetic counseling.”
Fox gave an example of a consumer who receives genetic testing results that they are negative for the BRCA1 and BRCA2 mutations that make people more susceptible to developing certain forms of breast cancer. Armed with that sort of information, the consumer might well decide to avoid getting mammograms. “That decision could be fatal,” warned Fox. He reports that testing negative for those particular mutations “lowers a person’s risk for developing breast cancer from about 12.5 percent to 12.4 percent. It’s clearly a mistake to avoid mammograms, but the information you receive back from companies like 23andMe don’t tell you any of this.”
The Marketplace host asked Fox how important the role of federal regulators is in determining the size of the genetic testing marketplace a decade from now. “The ways in which the FDA has asserted today its interest in regulating these techniques will have implications not just for genetic testing of individuals,” said Fox, “but for prospective children as well.”