The US Food and Drug Administration will allow the genetic testing company 23andMe to market tests for 10 serious disease and conditions, in a move that marks an about-face on the 2013 moratorium imposed on it.
The newly approved tests will use saliva samples to report on telltale markers for conditions such as Coeliac disease, Gaucher disease type 1, and blood clotting disorders. The tests will be marketed as part of the US$199 Health and Ancestry test that the company already provides.
The screening services are the first direct-to-consumer tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions.
In 2015 the FDA gave approval to 23andMe to test for mutated genes that may lead to diseases such as cystic fibrosis in children.
While some have welcomed the FDA approval, others are wary of direct-to-consumer genetic testing.
Speaking with the New York Times, James Beck, chief scientific officer of the Parkinson’s Foundation, said the decision set a dangerous precedent for the disclosure of information without prior genetic counselling. “Once you get the test and read the results, there is no going back,” Dr. Beck said.
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