US regulators let company test consumers for health risks
For the first time, the Food and Drug Administration said it would allow a company to sell genetic tests for disease risk directly to consumers, providing people with information about the likelihood that they could develop various conditions, including Parkinson's and Alzheimer's.
The tests are meant to be used to "make decisions about lifestyle choices or to inform discussions with a health care professional", the FDA stated in a news release.
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 authorized direct-to-consumer (DTC) tests are the DNA tests that can be taken by consumers at home to directly access crucial information on their genetic disposition to a variety of medical conditions. The GHR tests work by isolating DNA from a sample of saliva, which is then tested for more than 500,000 genetic variants. In addition, this may nudge them to make key changes in their lifestyle choices to minimize the incidence of these diseases.
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The FDA said 23andMe will not be required to submit additional tests for review prior to being marketed.
Thrombophilia (hereditary); a blood clot disorder. However, these new allowances in the genetic testing market do not include GHR tests that function as diagnostic tests. Apart from certain genetic variants, various environmental and lifestyle factors may be equally crucial in causing disease conditions. It said it may also exempt such tests from other companies that meet preliminary expectations.
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. The decision is expected to open the floodgates for more direct-to-consumer tests for disease risks, drawing a road map for other companies to do the same thing.
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