FDA seeks to regulate home gene tests

DNA strands from a double helix model

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.


By Gregory Warner

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 recreational or educational in purpose," says Reynolds.

One company, 23andMe, responded in a statement its tests are for research and education only. Another company, Pathway, already stepped out of the consumer market because of FDA pressure.

"You know, if you go into the hospital and you get a test there, they regulate those tests as medical devices already," says Daniel Carpenter, a professor of government at Harvard who wrote a book about the FDA.

The market for genetic testing is exploding. Lab fees for genetic tests are expected to exceed $6 billion this year. Dan Vorhaus, who writes the blog Genetic Law Report, says regulating over-the-counter tests will stifle innovation and raise prices.

"What we need right now is better transparency not more regulation," he says.

But regulation could end up helping the companies involved. Walgreen and CVS Caremark have all said they won't put the kits on the shelves until the FDA gives its blessing.

There's still one genetics test you can buy at Rite Aid -- a paternity test.

About the author

Gregory Warner is a senior reporter covering the economics and business of healthcare for the entire Marketplace portfolio.

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