A Medical Device Daily

The Federal Trade Commission (FTC) last week issued a new “Facts for Consumers” in which it discouraged the use of over-the-counter (OTC) genetic tests.

According to the FTC, some companies claim that their tests can help consumers screen for diseases, evaluate health risks, or suggest treatments, but it said that the FDA and the Centers for Disease Control and Prevention (Atlanta) advise that genetic tests should be performed in a specialized laboratory and that the results should be interpreted by a trained healthcare professional or genetic counselor.

The FTC also noted that these agencies “advise that genetic testing provides only one piece of information about a person's susceptibility to disease. Other factors, like family background, medical history, and environment also contribute to the likelihood of getting a particular disease.”

It said that the FDA and CDC say at-home genetic tests “are not a suitable substitute for a medical check-up.”

But if someone is considering the use of an at-home genetic test, the FTC provided a list of what it called “tips,” including:

  • Talking to a trained healthcare professional or genetic counselor about whether it might provide useful information about health and, if so, which test would be best.
  • Making sure to understand the benefits/limitations of any test before you buy or use it.
  • Asking a trained healthcare professional or genetic counselor to interpret test results. “Most companies that sell at-home genetic tests do not interpret the results.”
  • Discussing the results of the test with a trained healthcare professional or genetic counselor before making dietary or other health-related decisions. “Genetic test results can be complex and serious,” the FTC said. “You don't want to make any decisions based on incomplete, inaccurate, or misunderstood information.”
  • Being concerned about privacy since at-home test companies and check the company's privacy policy to see how it may use personal information. Such companies “may” post patient results online. “If the web site is not secure, your information may be seen by others.”