RxNews For Physicians

FDA Alert - "At-Home" Genetic Tests May Lack Scientific Validity

According to the U.S. Food and Drug Administration (FDA), the Federal Trade Commission (FTC), and the Centers for Disease Control (CDC), direct-to-consumer marketed genetic tests may lack scientific validity and provide questionable results.

The FDA, FTC and CDC alerted consumers about the facts surrounding the direct-to-consumers marketing of genetic tests. According to the FDA, which regulates the manufacturers of genetic tests, some of these tests lack
scientific validity. Others provide medical results that are meaningful only in the context of a full medical evaluation. The FDA and CDC say that because of the complexities involved in both the testing and the interpretation of the results, genetic tests should be performed in a specialized laboratory. And, the results should be interpreted by a doctor or trained counselor who understands the value of genetic testing for a particular situation.

Read the complete MedWatch 2006 Safety summary, including links to further FDA and FTC supporting information, at http://www.fda.gov/medwatch/safety/2006/safety06.htm#Genetic

MedWatch is your Internet gateway for timely safety information on drugs and other medical products regulated by the U.S. Food and Drug Administration. To see the latest official safety information and to report serious adverse events, visit http://www.fda.gov/medwatch.