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FTC warns consumers about at-home genetic testsSep 18 (HealthCentersOnline) - Federal agencies want consumers to understand the facts about at-home genetic tests before choosing to use a product. These tests may not be as reliable or valid as those performed in a specialized laboratory with trained professionals.
The Federal Trade Commission (FTC), which monitors and regulates advertising of consumer products, has issued guidelines about genetic tests. Direct-to-consumer genetic tests are regulated by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). These tests typically use a blood sample or swab from inside the cheek for testing. After the sample is collected, it is sent to a laboratory for analysis. But the FDA and CDC are skeptical about the interpretation of the results. A positive result indicates the lab found abnormal characteristics or changes in the genes of the sample. A negative result means there were no unusual characteristics. These results, however, offer only limited information about a person's risk of a disease. They do not take into consideration other contributing factors, such as family and medical history and environmental elements. Genes provide the blueprint for an individual's development, growth and body function. Genetic tests are most often used to determine if a person has inherited a gene alteration that has been associated with a certain disease. Gene mutations have been identified for breast, ovarian and prostate cancer, as well as other diseases. The agencies also warn consumers about the claims offered by the testing companies. Some products claim they are able to measure the risk of developing a specific disease, such as cancer, heart disease and diabetes. The FDA and CDC, however, are not aware of any statistics that prove the accuracy of these tests. According the FDA and CDC, at-home genetic tests are not a substitute for a traditional healthcare evaluation. Medical exams should be the starting point for diagnosing diseases and determining preventive treatment. For those who wish to pursue at-home genetic tests, the agencies suggest to first consult with a doctor or genetic counselor about the option. Healthcare professionals can suggest which tests might be best and explain the limits of the test. They can also help patients understand the test results because many companies that market the tests do not offer test result interpretation. While most medical tests that are used at home are evaluated by the FDA for safety and effectiveness, no at-home genetic tests have been reviewed by the FDA for the accuracy of their claims. Copyright 2000-2006 HealthCentersOnline, Inc.
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