FDA Warns DNA4Life, DNA-CardioCheck and Interleukin Genetics for DTC Genetic Tests

Last week, the US Food and Drug Administration (FDA) sent letters to three genetic testing companies for marketing unapproved direct-to-consumer (DTC) tests.DNA4Life, DNA-CardioCheck, Inc. and Interleukin Genetics, Inc., and concern diagnostics which FDA says are being marketed to consumers without being cleared.

In each of the letters, James Woods, FDA Deputy Director for the Patient Safety and Product Quality Office of In Vitro Diagnostics, says the agency is “unable to identify any … clearance number” for the tests cited, and instructs the companies to either show that the tests have been cleared, or provide their rationale for why the tests do not need to be cleared.

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