CGS-authored
The brave new world of medical entrepreneurship offers us this vision of the future: Buy a $100 kit at a local pharmacy, send off a sample of your saliva, get your own personal genetic profile back complete with information about which disease or condition you might be susceptible to. Walgreen's got a lot of attention a few weeks ago when it said it would start selling the kits. Then, just as quickly, it said it wouldn't, after questions were raised about the safety and effectiveness and overall wisdom of that idea. Today the FDA stepped in.
The FDA sent letters to five companies saying that direct-to-consumer genetic tests are now considered medical devices and are subject to regulation by the agency. At issue is whether the tests are delivering medical information.
Jesse Reynolds with the Center for Genetics and Society in Berkeley, Calif., says tests promise to tell you how you might respond to certain drugs or what your risk is for certain cancers.
"But they've thus far avoided regulation by claiming -- in their fine print -- to be...
The FDA sent letters to five companies saying that direct-to-consumer genetic tests are now considered medical devices and are subject to regulation by the agency. At issue is whether the tests are delivering medical information.
Jesse Reynolds with the Center for Genetics and Society in Berkeley, Calif., says tests promise to tell you how you might respond to certain drugs or what your risk is for certain cancers.
"But they've thus far avoided regulation by claiming -- in their fine print -- to be...