The FDA requested that five companies provide data that their diagnostic tests present scientific evidence that a test result, either positive or negative, is linked to a disease or the risk of one. They also want the companies to seek regulatory approval for the tests, although the companies maintain that this was not a necessary step to bringing the product to market.
The Government Accountability Office conducted an undercover investigation of the genetics tests, purchasing ten tests from four direct-to-consumer genetic tests companies—23andMe, deCode Genetics, Pathway Genomics, and Navigenics. Five staff members sent two DNA samples to each company; one with his or her real personal and medical information, and one with faux identifying and medical information.
Results varied markedly between companies and some information contradicted already diagnosed health conditions. Amongst the small sampling, the tests produced inconsistent results for the same disease 68 percent of the time.
Direct-to-Consumer Genetic Testing Facing Fire
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