It is the first direct-to-consumer genetic test the FDA has allowed to provide that information. The tests will be tentatively available to the general public in April, 2017.
The FDA said the tests are meant to provide genetic risk information but can not determine a person's overall risk of developing a disease or condition. In addition, this may nudge them to make key changes in their lifestyle choices to minimize the incidence of these diseases. Test results should not be used to diagnose or treat a specific illness, the agency added.
Americans may soon be sidestepping their doctors with an at-home DNA test by 23andMe that determines genetic risks for diseases like late-onset Alzheimer's and Parkinson's, thanks to a historic approval by the FDA.
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The company's genetic health risk reports (GHR) work by testing saliva samples for more than 500,000 genetic variants whose presence or absence may be associated with the conditions approved by the FDA.
By establishing special controls and a pre-market review exemption, "the FDA can provide a streamlined, flexible approach for tests using similar technologies to enter the market while the agency continues to help ensure that they provide accurate and reproducible results", Shuren said.
"But, it is important that people understand that genetic risk is just one piece of the bigger puzzle".
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The test can not give a full picture of a person's overall risk for diseases, because it does not account for environmental or lifestyle factors as well as every single genetic variant.
The development has opened the door to the development of special controls, envisaged by the FDA, pertaining to ascertaining the tests' accuracy, reliability, and clinical relevance. It said it may also exempt such tests from other companies that meet preliminary expectations.
The U.S. National Human Genome Research Institute has more on genetic testing.
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In 2015 the FDA gave approval to 23andMe to test for mutated genes that may lead to diseases such as cystic fibrosis in children.