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Probe of Genetic Testing Industry Finds Deceptive Marketing, Unreliable Results

An undercover investigation by the Government Accountability Office has found that companies that sell genetic tests to consumers to determine their risk for diseases engaged in “egregious examples of deceptive marketing.”

The GAO’s report, published Thursday as a Congressional panel  conducted a hearing looking into the industry, also found that the tests can be misleading, with consumers getting different results depending on which company they choose.

In its investigation, the GAO purchased 10 testing kits from each of four companies: deCODE Genetics, Pathway Genomics, 23andMe and Navigenics. Officials sent in saliva samples and then, posing as customers, called the companies to ask about their test results.

In some cases, investigators were told that sample donors were at lower risk for diseases that they already had, and in another instance the four companies provided different test assessments after they evaluated the same DNA sample, according to  The New York Times.

Industry officials disputed the GAO findings. Kari Stefansson, the executive chairman and president of research at deCODE genetics, told The Times that the charges in the report are “slanderous claims about sloppiness and misleading work.”

Stefansson said his company provides consumers with accurate genetic risk assessments based on validated science. He added, however, that there should be more regulation of the industry because without federal oversight, the quality of the tests varies from company to company.

The testing kits have been sold online for years, but attracted scrutiny in May when a company called Pathway Genomics said it would begin to sell its test kits in pharmacies, Business Week reports.

The Food and Drug Administration sent a letter notifying Pathway Genomics that it had never submitted its diagnostic kits for review, as required by law. The agency sent three similar letters to other companies in June, and another 14 letters on Monday.