FDA Allows Direct-to-Consumer Genetic Testing The U.S. Food and Drug Administration (FDA) recently authorized the genetic testing firm 23andMe to market direct-to-consumer tests that assess the risk of 10 diseases or conditions, including Parkinson’s disease and late-onset Alzheimer’s disease. They are the first direct-to-consumer tests to receive this authorization. The tests are meant to provide ... News in Brief
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News in Brief  |   June 01, 2017
FDA Allows Direct-to-Consumer Genetic Testing
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Special Populations / Genetic & Congenital Disorders / Regulatory, Legislative & Advocacy / News in Brief
News in Brief   |   June 01, 2017
FDA Allows Direct-to-Consumer Genetic Testing
The ASHA Leader, June 2017, Vol. 22, 11. doi:10.1044/leader.NIB3.22062017.11
The ASHA Leader, June 2017, Vol. 22, 11. doi:10.1044/leader.NIB3.22062017.11
The U.S. Food and Drug Administration (FDA) recently authorized the genetic testing firm 23andMe to market direct-to-consumer tests that assess the risk of 10 diseases or conditions, including Parkinson’s disease and late-onset Alzheimer’s disease. They are the first direct-to-consumer tests to receive this authorization.
The tests are meant to provide genetic risk information, but cannot determine a person’s overall risk of developing a disease or condition, because other factors—including environment and lifestyle—contribute to the development of a health condition. They are not diagnostic tests.
The FDA reviewed data for the 23andMe tests through a regulatory pathway for novel, low- to moderate-risk devices that are not substantially equivalent to an already legally marketed device. The FDA is also establishing criteria that clarify the agency’s expectations in ensuring the tests’ accuracy, reliability and clinical relevance.
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June 2017
Volume 22, Issue 6