Mail-in Genetic Testing Unreliable, Misleading

"Part of the problem for consumers is that when you hear genetic risk, it sounds formal and official, but the complexity is mind boggling even to the experts," agrees Susanne Haga, senior policy analyst at the Duke Institute of Genome Sciences & Policy.

As it is now, these tests will wrongly reassure and wrongly alarm consumers, as even with the best possible interpretation, there is so much room for error, King adds.

The FDA is planning to ramp up its regulation of genetic testing companies, said Dr. Jeffery Shuren, director of the FDA's Center for Devices and Radiological Health.

"When regulations over medical devices were first developed, FDA exercised discretion and did not regulate tests that were just being done in one lab. Now the situation has changed," Shuren told ABC News.

None of the genetic tests currently offered to consumers have undergone FDA premarket review. The agency recently sent letters to a number of companies informing them that their products appear to meet the definition of a medical device.

Shuren said the FDA is meeting with six genetic testing companies in the upcoming weeks to discuss the regulatory status of their products. The agency may take additional action after the meetings, Shuren said.

A family history is one way to assess your risk of certain health conditions without the use of a genetic test. To find out more, visit My Family Health Portrait: A Tool From the Surgeon General at https://familyhistory.hhs.gov/fhh-web/home.action.

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