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Volume49
MonthFebruary
Year2012
TitleAge of an Information Revolution: The Direct-to-Consumer Genetic Testing Industry and the Need for a Holistic Regulatory Approach
Author(s)Michelle D. Irick
First Page279
AbstractIn order to safeguard consumers and ensure the continued progress of a fledgling industry, determining how to interpret results and communicate them with consumers poses one of the most challenging and important tasks. In discussing the challenges the law faces in this area, this Comment will discuss: (1) consumer interfacing issues, such as in advertising and results analysis, faced by the genetic testing industry; (2) the methods DTC companies use in arriving at results and corresponding problems; (3) who may interpret and communicate results; (4) how the DTC genetic testing industry?s activities relate to the claims made regarding test results; and (5) who should bear the burden of responsibility. Finally, this Comment recommends a holistic approach that would take into account regulatory, legislative, self-regulatory, and educational methods to making the DTC genetic testing industry safer, more reliable, and poised to incorporate future advances in knowledge and technology.