The American Food and Drug Administration (FDA), has just ordered the 23andMe Company specialising in genetic tests to stop “selling DNA test kits aimed at determining the risks of contracting a disease from testing saliva” since the company has not been granted “regulatory authorisation to sell such products“. In a letter published on Monday, 25 November, the FDA stated that the use of this type of kit placed the latter “in the category of ‘medical devices’, which must be approved before being launched on the market“.
The American authorities prevent a company from selling a saliva test
Publié le : 26 November 2013
According to the 23andMe Company, the kit “should help clients determine their genetic risks for several diseases including diabetes, breast cancer or cardiovascular diseases“. As far as the American authorities are concerned, “some applications for which the kit is used give ‘particular cause for concern’ due to the ‘potential consequences on health’ of false positive or false negative results such as the presence of genes that predispose to breast cancer“. Finally, the FDA is deeply concerned by the fact that, despite the numerous discussions it has had with 23andMe, it “still has no guarantee that this company has clinically validated this test for the uses cited“.