Green light for home DNA testing in the United States. Two years after having to stop marketing its DNA tests, the American company 23andMe is putting it back. This time, it obtained “a regulatory framework allowing a direct sale to consumers”, explained to AFP the CEO of the company, Anne Wojcicki. With this authorization from the Food and Drug Administration (FDA, the American Medicines Agency) to sell its DNA tests directly, Americans will be able to verify whether they are carriers of genetic mutations that may increase the risk of presenting certain diseases.
Unlike two years ago, these new genetic tests, available over the counter in the United States, do not offer the possibility of assessing the risk of cancer, cardiovascular illnesses, of diabetes or from Alzheimer’s disease. This exclusion eliminates the risk of negative consequences linked to biased, false negative or positive results. In 2013, the FDA expressed concern about aggressive or inappropriate examinations and / or treatments that could be undertaken by a person after poor results on these tests.
36 hereditary diseases
With the new DNA tests, only genetic information relating to 36 hereditary diseases, including cystic fibrosis, can be revealed.
To be able to analyze their genetic risk at home without going through the doctor’s box, Americans will have to pay 199 dollars, or 100 euros more than the tests that had been launched two years earlier.
In France, the bioethics law prohibits the sale of DNA tests.
>> To read also:Down’s syndrome: DNA tests would be more effective than amniocentesis
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