Good gene hunting: commercializing safety and efficacy of home genetic test kits.
The rapid advancement of genetic identification as a means of diagnosing or identifying the existence of a genetic trait for preventative and reproductive concerns should compel legal experts to determine whether there is sufficient safety and efficacy in genetic tests. Genetic testing has been used by physicians for a number of years to enhance their allopathic practice. Specifically, genetic tests are now being considered as aids in understanding the development and proliferation of certain diseases in society as a whole, and in specific ethnic and familial groups. The purposes of this paper are to: (1) articulate what genetic testing offers, by way of definition and scope; (2) identify statutory and regulatory limitations on the development, distribution, and use of genetic tests; and (3) consider whether the potential availability of home genetic tests should be made accessible to the American public. This paper will further provide a proposed regulation to encourage the development and distribution of home genetic tests.
Stevenson
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D001709:Biotechnology; D035082:Federal Government; D005820:Genetic Testing / Q000379:methods*; D005826:Genetics, Medical; D033161:Government Regulation; D006801:Humans; D007753:Laboratories / Q000592:standards*; D026706:Paternalism; D026684:Personal Autonomy; D011933:Reagent Kits, Diagnostic; D018570:Risk Assessment; D012648:Self Care; D013219:State Government; D014481:United States; D014486:United States Food and Drug Administration
D011933:Reagent Kits, Diagnostic