For the first time, USA regulators have authorized a company to tell consumers directly about their individual genetic risk of certain diseases and conditions without involving a health care professional.
The newly approved tests work by isolating DNA from a saliva sample.
The FDA said the authorization came after reviewing data from the company's tests and peer-reviewed literature that demonstrated the GHR tests "correctly and consistently identified variants associated with the 10 indicated conditions or diseases from a saliva sample". Most, like factor XI deficiency, a blood clotting disorder, and Gaucher disease type 1, an organ and tissue illness, and celiac disease are rare. In 2013, the agency told 23andMe to stop selling its personal genome kits in the United States until they gained FDA approval by proving they were accurate.
Meanwhile, the FDA approval has not doused the anxiety over the accuracy of GHR tests.
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Robert Green, a professor of medicine at Harvard Medical School, says people should be able to access genetic information in whatever way is best for them.
But some are stillconcerned about whether the genes in question actually correspond to a higher risk of disease reliably enough to warrant direct-to-consumer marketing and testing, as opposed to genetic testing with the guidance of a professional.
But Shuren asked people to understand that mere genetic risk does not suggest a person will be developing a particular disease. 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.
The tests can be valuable and worthwhile, Koppel believes, especially if an individual is anxious about hereditary traits and gets a test result that could raise valid concerns.
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