GAO Investigation Questions Validity of DNA Testing Kits

Home DNA testing kits claiming to analyze consumers' DNA for genes which affect diseases like heart disease, cancer, or diabetes are misleading because they provide results that are ambiguous, medically unproven, or both, according to federal investigators.

These were the results from an investigation by the Government Accountability Office (GAO), which has led to a Senate hearing into direct-to-consumer genetic testing. Genetic test kits are often advertised on the Internet, in prices ranging from less than $100 to about $400.

According to Gordon Smith, R-Ore., chairman of the Senate Special Committee on Aging. Smith, who called for the study,"This industry represents a fraudulent mutation of that promise," He says that consumers should visit their doctors for tests if they are concerned about particular diseases.

Kits from four companies Genelex of Seattle, Suracell of Montclair, N.J., Sciona of Boulder, Colo., and Greensboro, N.C., based Internet-marketing company Market America have been investigated and called to testify on Thursday. According to their advertisements they sample four to 19 genes to provide consumers with personalized diet and lifestyle recommendations.

The GAO collected DNA samples from two test subjects, a 9-month-old girl and a 48-year-old man, created 14 fictitious consumers from those samples, and sent the tests back for analysis.

Although the websites for all four companies claimed that the test results were not intended to diagnose disease, the GAO found the personalized information sent back from all 14 "predict that the fictitious consumers are at risk for developing a range of conditions" including diabetes, cancer, high blood pressure and heart disease.

Researchers say, "Medical predictions in the test results cannot be medically proven at this time."

It was also found that recommendations and health predictions to the fictitious consumers varied widely, even for samples taken from the same person. In addition two companies, Market America and Suracell use the results to promote expensive dietary supplements.

According to Ttest kit executives they are promoting better diet and lifestyle choices. Also a growing number of studies have begun to show gene tests to be useful.

Howard Coleman, CEO of Genelex says, "These tests bring benefit to people and allow them to change their behaviors in ways that do improve their health." He reports sales of 500 to 600 of the $400 test kits annually from his company.

After publication of the report Rosalynn Gill-Garrison, chief science officer at Sciona said that the company does not predict susceptibility to disease.

She says, "We provide information for people on diet, nutrition and lifestyle actions they can take based on genetics." Gill-Garrison reports sales of tens of thousands of test kits which is currently sold at $252.