Banned in the United States, a genetic test developed by the 23 and me Company is authorised in the United Kingdom

Publié le 2 Dec, 2014

In 2013, the American authorities (FDA – Food and Drug Administration) ordered the 23andMe Company to stop marketing DNA test kits advertised as capable of identifying (not diagnosing) the risks associated with certain diseases such as Parkinson’s disease, cystic fibrosis, sickle cell disease or even some cancers such as breast cancer – from saliva (See Gènéthique 26.11.2014 and press reviews 13.12.2013). And rightly so because the FDA never obtained confirmation that the 23andMe Company had clinically validated the test for advanced use.


Despite this ban, the 23andMe Company has persevered. In fact, this very test is currently marketed in the United Kingdom for £125.00, i.e. approximately €128.00 According to the English-speaking media, this product can be sold in the United Kingdom because it is not advertised as diagnosing diseases. Therefore, “it does not have to be approved by the UK’s Medicines and Health Care Products Regulatory Agency”. However, the British Health Minister has encouraged British citizens to “think carefully” before using the genetic test, emphasising that “no test is 100% safe” 


Mark Thomas, Professor of Evolutionary Genetics at University College London commented as follows, the technology “is here, they [technological companies] are doing it, and it’s not going away”. However, this does not stop a certain number of questions from being asked.  He goes on to ask “Are these companies responsible? Is the information they are giving you scientifically sound and is it handled in a responsible way? Genetics is messy and complicated. If people are expecting their test to say, you’ve got this variant, therefore you’re going to get this disease, they need to know that this is rarely the way it is” (02/12/2014) – (Judith Sinnige) 02/12/2014 – (Samuel Gibbs) 02/12/2014 – (Charlie Cooper) 02/12/2014

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