FDA Approves At-Home Genetic Tests
On April 6th, the U.S. Food and Drug Administration announced the approval of the first direct-to-consumer genetic tests. The tests—23andMe Personal Genome Service Genetic Health Risk (GHR) tests—screen for 10 genetic diseases and conditions, including celiac disease, Parkinson's, and late-onset Alzheimer's.
Information about genetic predisposition to certain health problems can help individuals and their health care providers make important decisions about lifestyle choices, additional testing, early treatment—if necessary—and others. According to the FDA, genetic risk is only one piece of the overall health puzzle—it does not mean a person will or will not develop the disease.
Prior to granting approval, the FDA established special controls, assuring the safety, accuracy, reliability, and clinical relevance of the at-home genetic tests. Genetic tests used for diagnosis or to determine a preventative course of treatment—such as the BRCA test, which indicates a high risk for breast and ovarian cancer and often leads to prophylactic surgery—are excluded from this FDA approval.
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