In the wake of an undercover GAO investigation, direct-to-consumer genetic testing is being called misleading and the FDA may be preparing to regulate the tests. DNA samples of five people sent away for testing showed inconsistent results for the same disease 68 percent of the time; also, four out of the five people tested got results that conflicted with their actual medical conditions and family histories. The tests under investigation cost from $300.
Testifying before a House Energy and Commerce subcommittee, Gregory Kutz of the Government Accountability Office accused the testing companies of deceptive marketing practices; he also called the results "misleading and of little use to consumers." And according to Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health at the FDA, the agency has sent letters to a number of genetic testing companies informing them of the coming move to regulate them. The companies named were: Pathway Genomics, Knome Inc, Navigenics Inc, deCODE Genetics and 23andMe.
Shuren said that based on the companies' claims about their test results, their products meet the definition of a medical device, yet none have been cleared by the FDA to ensure the results are "accurate, reliable and clinically meaningful.”
Via Reuters.
Ms. Graham is a writer and editor with a current focus on health and wellness. To read more of her articles, please visit her columnist page.Edited by
Erin Monda