A new over-the-counter kit slated to hit drugstores on May 14 may give consumers new insight into their propensity for disease. But is it legal? And if it is, is it a good idea?
The DNA reports offered by Pathway Genomics will test for a genetic predisposition for more than 70 common diseases and conditions, including Alzheimer's, breast cancer and diabetes. The test also claims to be able to tell consumers their chances of becoming obese, developing psoriasis and going blind. It could provide information about the risks of having a baby with cystic fibrosis, Tay-Sachs and other genetic disorders. The test also promises insights into how caffeine, cholesterol-lowering drugs and blood thinners might affect a consumer.
The tests will be available at about 6,000 of Walgreens' 7,500 stores on Friday. Unless, that is, the FDA has something to say about it. In an interview with the Washington Post, Alberto Gutierrez, director of the FDA's office of in-vitro diagnostics said, "We think this would be an illegally marketed device if they proceed. They are making medical claims. We don't know whether the test works and whether patients are taking actions that could put them in jeopardy based on the test."
Company officials at Pathway Genomics, however, claim the test does not require agency approval because the analysis will be done at the company's lab.
Legalities aside, this new OTC genetics test raises big concerns over the propensity for consumers to misread results and put their health at risk as a result. For example, the breast cancer test will screen for only a few of the genetic mutations associated with the malignancy, so it won't exclude the possibility of getting the disease because of other mutations or nongenetic reasons. But women who don't understand these facts may pass on future mammograms depending upon the results of their test. In the opposite scenario, consumers who receive a result suggesting an increased risk for a disease could subject themselves to unnecessary follow-up tests and treatments.
There is also the potential backlash to consider. For instance, if your genetic tests suggest you have a propensity for hypertension or worse, leukemia, will it hinder your ability to obtain health care coverage in the future? That question remains to be answered.
I have to admit I'm intrigued by the idea of a test that could let me know my future risk for disease .... particularly Alzheimer's disease, an illness that destroyed my grandmother in her late 60s. But I'm not really sure what I would do with the results if my tests suggest an increased risk. Buy more notepads? Take more ginko? Buy a book of crossword puzzles?
What do you think? Is this new over-the-counter test a boon for consumers looking to protect their health and prepare for the future? Or will it simply add to confusion and anxiety?
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