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from Part V - The Impact of Genetic Information
Published online by Cambridge University Press: 27 August 2021
The recent FDA marketing authorizations granted for testing for mutations associated with hereditary breast and colon cancer, as well as pharmacogenomic susceptibilities, provide an opportunity to re-examine the medical as well as regulatory underpinnings of DTC genetic testing. In this chapter, we first examine the historical emergence of enabling technologies that have provided for the availability of DNA sequence information on a broad scale, the efforts by the medical community to incorporate these advances into models of “precision” or “personalized” medicine, and the risks and benefits of offering access to DNA germline sequence analysis outside of the traditional medical model. We then turn to the current and proposed regulatory schemes to provide oversight over DTC genetic testing, with a focus on the role of the FDA as an information regulator and guardian of public health and safety.
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