Empowering Consumers through Accurate Genomic Tests
By Jeffrey Shuren,
FDA Voice
| 06. 26. 2014
Untitled Document
We’ve come to recognize that almost every disease has a genetic component, and many consumers now are eager to know more about their genetic profiles. They need only send a sample of their DNA collected from their saliva or from a cheek swab to a company, and in exchange they’ll get back information about their genetic risk for development of future disease.
FDA understands and supports people’s interest in having access to their genetic information and believes such information can help them make more informed choices about their health – so long as that genetic information is accurate – that the results are correct, meaningful and written in a way that consumers can understand. FDA reviews genetic tests for medical conditions, whether they are intended to be ordered by a healthcare practitioner or directly by the consumer, to assure that consumers receive accurate test results.
Telling someone they are at high risk for a life-threatening cancer when they are not—or that they are at low risk for diabetes when they actually are at high risk for this chronic...
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