Should the FDA regulate consumer genetic tests?

The U.S. Food and Drug Administration is evaluating if and how to regulate consumer genetic tests that promise information on inherited health risks for certain diseases.
Written by Andrew Nusca, Contributor

You've surely heard about them: genetic tests that you can order online that, with one swipe of a cotton swab in your cheek, can tell you more than you ever dreamed of about where your family originated and what types of diseases for which you may carry elevated risk.

The U.S. Food and Drug Administration is reportedly evaluating whether to regulate these tests and if to regulate certain tests differently from others, depending on what they're designed to reveal.

Consumer genetic tests have been growing in popularity in recent years as the technology for them gets cheaper and cheaper. Once more than $1,000 for a single test, the kits can now be had for as little as $99 from outfits such as 23andMe, Navigenics and DeCodeMe.

In April, the rubber hit the road: Pathway Genomics struck a deal with pharmacy king Walgreens to distribute their product in more than 6,000 stores. (The firm has since stopped selling tests to consumers.)

Now, Reuters reports that the FDA is wondering how much of a role it should play in the practice, specifically for those tests that have health implications, versus ancestry information.

The worry: that the limitations of the test kits aren't clear enough, or that information about health risks fir diseases such as Parkinson's, Huntington's or certain types of cancer may lead to consumers taking medical action on their own without first consulting a doctor.

An advisory panel meeting is scheduled for today and tomorrow, during which the FDA will ask outside experts to evaluate whether there's value in placing tests into different categories: those that look for inherited disease, those that predict the risk of future disease and those that predict response to specific drug treatments.

Plus, the most fundamental of concerns: just how accurate must these tests be for their claims to be verified? How can you tell if these companies are selling snake oil?

Currently, over-the-counter genetic tests carry disclaimers stating that they are for "educational and informational" purposes only. Is it enough to protect Americans?

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