Personal genetic tests retailed by five corporations need to undergo regulatory assessment before sale, U. S. watchdogs said, one month after Walgreens terminated plans to retail a similar product in its shops.
Customers might make up their mind based on the result of these assessments, which should be evaluated under similar procedure utilized for medical gadgets, the Food and Drug Administration said in letters issued on Friday to 23andMe of Mountain View, Navigenics of Foster City, deCODE Genetics, Illumina Inc. and Knome Inc.
The agency will come to a decision whether the kits can stay in the market after listening to the claims of the firms regarding its advantages.
The regulatory letters send the first indication that the Government agency intends to attack corporations marketing products, which claim to forecast genetic ailments by means of DNA samples.
23andMe, deCODE Genetics and Illumina market tests examine patients for their probability of contracting health diseases or their reaction to a lot of drugs.
According to the FDA, none of the firms have presented their kits for sanction.
Navigenics and Knome manufacture high-grade testing and software paraphernalia, which genetic firms utilize to examine DNA samples. Under FDA laws, these equipments should also go through assessment as medical gadgets.