Risk & Innovation: An Interpretive Policy Analysis of DTC Genetic Health Test Regulation

• In Event: Interrupting Innovation: Pausing to Examine New Biotechnologies - II

Abstract

Direct-to-consumer (DTC) genetic testing has been publicly available since 2004, and as of 2018 over 16 million people have purchased a test from websites such as 23andMe and Ancestry.com. This paper addresses questions of how at-home genetic tests are regulated through notions of risk and innovation, and how that regulation is affected by research organizations and private corporations. The categorization of DTC genetic tests reflect the legal, ethical, and cultural debates of what we should expect from genetic technologies in terms of medical and clinical standards. DTC genetic tests, or “Genetic Health Risk Reports,” are legally classified as a Class II device, presenting a “moderate-risk” of harm or injury to the user. The FDA provides a technical definition of what "moderate risk" is, but does not offer a precise definition of "genetic health risk." This creates heterogeneous conceptions of genetic risk that extend to the public through the marketing of DTC genetic tests by 23andMe as “for the public good”. The FDA’s categorization of DTC genetic tests is influenced by driving ideas that the emergent research and advances in biotechnology will lead to beneficial innovation. Through interpretive policy analysis, this research will probe how notions of risk, disease, and diagnosis inform emerging policies and regulatory practices.. In considering the legal structure of consumer genetics, this paper not only provides an empirical case study of how the FDA regulates DTC genetic test but moreover contributes to scholarship that deals with the legal challenges of emerging biotechnologies.

Author

• Hined A Rafeh, Rensselaer Polytechnic Institute