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  • How can consumers use information from direct-to-consumer tests?
    While direct-to-consumer tests can lead to consumers becoming more engaged in their overall health and lifestyle decisions, results from direct-to-consumer tests should not be the sole basis of any type of medical decision making as these tests provide only one layer of a bigger picture. Therefore, results from direct-to-consumer tests should always be discussed with your health care provider. In addition, these tests are not a substitute for visits to a health care provider for recommended screenings or appropriate follow-up and should not be used to determine any treatments.
  • Are direct-to-consumer tests accurate?
    No test is 100% accurate. Some tests may be wrong due to an error in the test, and some results may be wrong due to an incorrect interpretation of the meaning of the result.
  • I received opposite or different results from two different companies. Why?
    Different companies may test for different sets of variants, much like a store may offer different brands of products. One direct-to-consumer test company may look for one set of variants linked to a disease or condition, while a different test company may look at a different set. Additionally, direct-to-consumer tests may disagree on the interpretation on whether a variant is disease-causing or not. Experts don't always agree and the reasons for this vary. For example, one direct-to-consumer company may have private information about a variant based on their test population that another test company does not have. Another direct-to-consumer company may use different criteria when determining whether a variant is linked to a disease or condition. It is important that consumers understand what is being tested when they receive results from different companies and whether they are testing the same genetic variant. For direct-to-consumer genetic tests, you may consider speaking with a genetic counselor, board-certified medical geneticist, or other equivalent health care provider. If you have concerns about a particular test result received from a direct-to-consumer test company, you can report problems directly to the FDA through MedWatch, the FDA's voluntary reporting program.
  • If my direct-to-consumer test is negative, does that mean that I will not develop that condition?"
    Not necessarily. Many diseases or conditions may be caused by a number of factors including genetics, lifestyle, and environmental factors. Additionally, not all genetic tests are looking for all of the variants that can contribute to disease development. For example, some tests might only look for a couple of variants, even though hundreds or thousands of variants can contribute to disease development. Therefore, it is especially important to continue routine medical preventive care or recommended screenings even if you receive a negative genetic direct-to-consumer test result. Consumers should consult with their health care provider about the right steps to take following receiving results from any direct-to-consumer test.
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