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11/26/2013

The FDA and Home DNA Testing

by Craig Klugman, Ph.D.

For those on the cutting edge (or as we called it in tech journalism, “the bleeding edge”) of science, the Human Genome Project’s promise could be found in home genetic testing. Take a cheek swab (or some saliva). Put the sample in the mail. Receive your DNA map (not a complete map, just sections of DNA that have associations with certain conditions). It was the way to know yourself by seeing your genetic risk profile: What disease conditions do you have a susceptibility to? What actions can you take to avoid the demons lurking in your DNA?

In late 2007 23andMe offered the first at home DNA testing kit. Flash forward five years and over 400,000 people have paid for their gene mapping. Late last week,  the Federal Drug Administration (FDA) told the company to cease and desist selling their home DNA kit. According to the FDA’s warning letter, 23andMe is selling a product intended to prevent serious disease without going through required testing and receiving FDA approval. The gene kit is now considered a medical tool and thus falls under the FDA’s purview. Last week, for $99 you could have purchased the kit on Amazon. Today the listing says “Currently Unavailable.”

The idea behind testing was self-knowledge and hopefully making changes to improve your health behavior. If you know your risks, then you can modify behavior to reduce the chance of developing diseases to which you may be susceptible. If you have the markers for lung cancer, then you may want to give up smoking. If BRCA1 and 2 show up in your profile, perhaps more frequent mammograms are in order. The idea is that the more information you have, the more you can control your current and future health.

The results could also have the opposite of the intended affect. Someone who does not have lung cancer susceptibility might think that smoking is fine because the risk factor is absent. One must also consider the regret that comes with finding out information that you may not have wanted to know such as that your father is not your genetic father. Or you might change your behavior to avoid a genetic risk and decrease your quality of life. For example, maybe you love playing sports but learn you have a genetic profile for someone with heart disease. Would you give up something that you enjoy based on a probability? Becoming sedentary could cause more damage than continuing to play sports.

Part of the problem is that the presence of DNA markers does not guarantee that someone will have a disease or condition. Interpreting the data is still more art than science. A friend had his DNA mapped by several different companies and they each offered a vastly difference interpretation of what his profile meant.

23andMe did not offer this test completely out of their interest in humanity. Like most companies, there is a search for ways to profit. The samples they test are entered into a database that is used in research to find new correlations as well as to sell marketing materials to other companies. If you have the baldness gene, you may suddenly find yourself receiving ads for hair regrowth.

Is this warning a case of the government reaching too far and stifling technological innovation? Should people have the autonomy to cost effectively learn their DNA profile in order to take action to improve their health and avoid potential genetic pitfalls? Does misuse of this kit pose a likely potential harm? According to the FDA these questions need definitive answers. Asking question is good. I just wonder why it took the FDA five years to start asking them.

This entry was posted in Featured Posts, Genetics, Health Regulation & Law. Posted by Craig Klugman. Bookmark the permalink.

One response to “The FDA and Home DNA Testing”

  1. Aric Edwards says:

    The discussion has been ongoing since the 2006 Government Accountability Organization’s report. The issue is the novelty and difficulty in regulating (or adjusting the regulations) the DTC genetic tests.

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