Home DNA tests make 'unrealistic claims:' MDs
Last Updated: Wednesday, August 18, 2010 | 5:02 PM ET
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Consumers need to be protected from home genetic tests that are sold online and make unrealistic claims, doctors say.
Direct-to-consumer genetic tests are marketed and sold to people who want to access their genomic data, in some cases without the involvement of a doctor or insurance company.
Medical professionals "must ensure that rapidly evolving and multiplying genomic technologies are responsibly harnessed and that their promise is not oversold to the public," Dr. James Evans of the University of North Carolina at Chapel Hill School of Medicine and co-authors write in a commentary in Wednesday's New England Journal of Medicine.
"Consumers must be protected from unrealistic claims and the misinterpretation of complex and dynamic genomic information," Evans, a medical geneticist, and the other authors said.
The article, "Preparing for a consumer-driven genomic age," argues health professionals should help patients interpret the results of such tests and advise them on followup.
There is little evidence supporting the clinical validity of such tests, the authors said, noting the U.S. Food and Drug Administration does not require companies to submit data for most genetic tests before they go on sale.
Test kits' reliability questioned
In May, Walgreen Co., the largest drugstore chain in the U.S., said it will hold off selling what was to be the first over-the-counter genetic test after the FDA said the kit's effectiveness hasn't been proven.
The kit uses a saliva swab to look for signs of inheritable diseases like Alzheimer's.
In July, federal investigators in the U.S. issued a report saying the results of genetic testing kits appear misleading and unreliable for predicting inheritable diseases.
Company executives responded that results differed because each company uses different standards to analyze DNA and that they are working on standardizing methods.
With files from The Associated PressShare Tools
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