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How can I be sure that genetic testing is valid and useful?
Before taking a genetic test, it's important to make sure the test is valid and useful. A genetic test is valid if it provides accurate results. Two primary measures of accuracy apply to genetic testing: analytical validity and clinical validity. Another measure of the quality of a genetic test is its usefulness or clinical utility.
Analytical validity refers to how well a test predicts the presence or absence of a particular gene or genetic change. In other words, can the test accurately detect the presence or absence of a specific genetic variant?
Clinical validity refers to the degree to which the analyzed genetic variant is associated with the presence, absence, or risk of a particular disease.
Clinical utility refers to whether a test can provide useful information about the diagnosis, treatment, management, or prevention of a disease.
All laboratories that perform health-related testing for disease prevention, diagnosis, or treatment, including genetic testing, must comply with federal regulatory standards called the Clinical Laboratory Improvement Amendments (CLIA), and even stricter state requirements. CLIA standards cover how testing is performed, the qualifications of laboratory personnel, and each laboratory's quality control and testing procedures. By controlling the quality of laboratory practice, CLIA standards are designed to ensure the analytical validity of genetic testing.
The CLIA criteria do not address the clinical validity or clinical utility of genetic testing. The U.S. Food and Drug Administration (FDA) requires information on the clinical effectiveness of certain genetic tests, especially those that may affect a person's health care. Additionally, states may require additional information on the clinical validity of laboratory tests performed for persons residing in the state. Test takers, healthcare providers, and health insurers are often the ones who determine the clinical utility of genetic testing.
It is difficult to determine the quality of genetic tests sold directly to the public. Some direct-to-consumer genetic testing providers are not CLIA certified, and many direct-to-consumer genetic tests are not regulated by the FDA, making it difficult to tell whether these tests are effective. If direct-to-consumer genetic testing providers provide easy-to-understand information about the scientific basis of their testing, it could help people make more informed decisions. It may also be helpful to discuss any concerns with a healthcare provider before ordering a direct-to-consumer genetic test and after receiving the test results.
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