The US health authority has ordered a start-up to withdraw its DNA tests from sale. The products have not received prior authorization and lack reliability.
In the United States, it is better to be in good standing with the health authority. The drug agency’s equivalent, the FDA (1), ordered start-up 23andMe to cease marketing DNA test kits. These tests would make it possible to determine, from a saliva sample, to what risk of disease the client is exposed to. But these tests to be carried out at home had not received authorization.
Powerful financial support
The FDA specifies in an open letter to the company 23andMe that this “saliva test kit and its personalized genomic services” must obtain marketing authorization before they are released for sale. It considers that this product is part of medical equipment, but has not received “any assurance that the company has validated [le produit] for the intended uses. »No clinical study confirming the effectiveness of the tests has been reported to the health authority to date.
That hasn’t stopped the company from putting the DNA test kits up for sale and promoting them. 23andMe has even received financial support from Google Ventures, but also from pharmaceutical groups (Johnson & Johnson, Roche). Its flagship product is very popular with Americans. The kit allows customers to determine the genetic risks to which they are exposed for several diseases, including diabetes, breast cancer or cardiovascular conditions. At least that’s what 23andMe claims. The FDA, for its part, raises several sensitive points.
Risk of false results
On the one hand, some applications of the DNA test kit present a potential danger to the health of customers. False positive or false negative results could have adverse effects. “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 detection tests while a false negative test could lead the person to ignore the existence of a real risk, ”explains the FDA in its letter.
The health authority also asks the question of reading the tests. Usually, the result of a genetic or other test is read in the presence of a healthcare professional. Here, it is transmitted from the laboratory to the customer, without an intermediary. It is therefore possible that customers may misinterpret the results. Therefore, the FDA concludes, “23andME must immediately stop promoting the products until it receives clearance. “
A spokesperson for the start-up confirmed to AFP that he had received this letter. The leaders now have 15 days to rectify the situation. If they choose to ignore this warning, the FDA specifies that it will put in place corrective measures (seizures, injunctions, financial penalties).
(1) Food and Drug Administration
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