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Chief executives from three genetic testing companies will appear on Capitol Hill Thursday as lawmakers examine the consequences of mass-marketing personalized DNA tests to the public.
Genomic testing companies market saliva-based kits designed to detect whether individuals are genetically predisposed to get certain diseases and medical conditions. Such tests have been sold online for years, but they began attracting federal scrutiny in May when Pathway Genomics announced plans to market its products in retail pharmacies.
San Diego-based Pathway ultimately backed down from that plan after the Food and Drug Administration sent the company a letter indicating that it never submitted its products for federal review, a requirement for medical devices.
In June the FDA issued similar letters to several other genomic testing firms.
The Energy and Commerce Committee will hear testimony from the FDA and three genomic testing companies: 23andMe, Navigenics and Pathway Genomics Corp.
The proliferation of consumer-marketed genetic tests has troubled many public health officials and doctors who worry that the products are built on flimsy data that misleads consumers.
The biology of how DNA variations actually lead to certain diseases is still poorly understood, although a number of public and private institutions have been working to find answers.