July 23, 2010

Government Investigating Genetic Testing Companies

Individuals who send off saliva samples to genetic testing companies to determine whether or not they are at risk for diabetes or certain forms of cancer may receive different results depending on which company they select, according to a Reuters report Thursday.

In the article, reporter Julie Steenhuysen states that government officials conducted an undercover probe of four unidentified genetic testing firms.

As part of the test, five people sent away DNA for testing to each of the companies. According to Steenhuysen, "Four out of five donors got test results that conflicted with their actual medical conditions and family histories"¦ [and] the tests produced inconsistent results for the same disease 68 percent of the time."

"Assuming these tests are credible, one would expect that identical DNA would receive identical predictions," Gregory Kutz, a member of the Government Accountability Office (GAO), told a U.S. House of Representatives panel investigating the genetic testing programs in a prepared statement. Kutz added that the results "are misleading and of little use to consumers."

The tests that were involved in the study ranged in cost from $300 to $1,000, according to Steenhuysen, and now face possible regulation from the U.S. Food and Drug Administration (FDA) as medical devices, based on comments made to Reuters from Dr. Jeffery Shuren, the Director of the FDA's Center for Devices and Radiological Health.

Six companies that market their tests directly to consumers--Pathway Genomics, Knome Inc, Navigenics Inc, deCODE Genetics and 23andMe--have been sent letters from the FDA regarding the move to regulate them, according to Steenhuysen.

Officials from 23andMe, a privately-owned and operated biotech and genetics firm in Mountain View, California, said in a statement that the GAO refused to discuss the rest results with them.

"We are confident in our service's accuracy, reliability and value," they added. "However, we embrace the ideas that the FDA offered today and look forward to helping to develop a regulatory framework that provides standards and transparency across the industry."


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