Home DNA tests make 'unrealistic claims:' MDs

August 21, 2010

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Wed Aug 18, 5:02 PM

SASKATCHEWAN (CBC) - 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. 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, " , 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.

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.

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