Doing a DNA test from home to determine, from a saliva sample, to what risk of illness you are exposed seems science fiction to you? Think again, this practice is currently in vogue in the United States…but not for long. The start-up 23andMe indeed offers a DNA test kit to be carried out at home which seems to be a great success among Americans. It would make it possible to know the genetic risks incurred for diseases such as diabetesbreast cancer or other cardiovascular disease without having to go to your doctor.
Corn the Food and drug administration (FDA), the equivalent of our national drug agency, has just sent a letter to the company ordering them to stop marketing the “saliva test kit and its personalized genomic services”. The FDA reminds the start-up that this product is part of the medical equipment for which a marketing authorization is mandatory before it is put on sale. This authorization has not been issued and no clinical study is capable of confirming the effectiveness of this test. The 23andMe company therefore has 15 days to fix its situation at the risk of being inflicted with corrective measures such as a seizure or a fine.
The American health authority points to the potential danger presented by the DNA kit for the health of customers. “For example, if the test gives a false positive result for breast or ovarian cancer, it could lead a woman to undertake prophylactic treatments such as surgery, preventive chemotherapy or aggressive screening tests while a false negative test could lead the person to ignore the existence of a real risk”, argues the FDA in its letter.
Among other things, the risk of misinterpretation of the results is also present, since it is not examined by a health professional, but transmitted directly from the laboratory to the client.
