The FDA authorises the direct sale to consumers of the first genetic disease screening test



On Thursday, in the United States, the Food and Drug Administration (FDA) authorised the direct sale to consumers of the first genetic screening tests. Marketed by the company 23andMe, this test assesses a person's genetic predisposition for 10 diseases and disorders.

 

The tests are carried out by isolating the DNA from a sample of saliva for diseases such as coeliac's disease, Gaucher disease type 1 and blood coagulation disorders as well as Parkinson's disease or Alzheimer's disease. The tests will be marketed as part of the $199 health and ancestry test that the company already provides.

 

The tests can be used to"make decisions about lifestyle or to shed light on discussions with health professionals", announced the agency in a press release.

 

Although consumers can have direct access to certain information about genetic risks from now onwards, Dr. Jeffrey Shuren, Director of the FDA's Centre for Devices and Radiological Health, emphasises that "it is important for people to understand that genetic risk is only one piece in the puzzle. It doesn't mean that they will or won't develop a disease".

 

The authorisation marks a turning point and rechallenges the moratorium imposed on these questions in 2013.

 

When interviewed by the New York Times, Doctor James Beck, Lead Scientist at the Foundation for Parkinson's Disease stated that the decision constituted a dangerous precedent for the disclosure of information without prior genetic consultation: "Once you've had the test and read the results, there's no going back".


Sources: 

Bioedge (Xavier Symons) 07/04/2017 ; Medical XPress (06/04/2017)