Gatekeepers and Goalposts: The Need for a New Regulatory Paradigm for Whole Genome Sequencing Results

22 Pages Posted: 11 Oct 2012

See all articles by Trevor Woodage

Trevor Woodage

University of Minnesota - Twin Cities - School of Law; Fish & Richardson P.C.

Date Written: October 10, 2012

Abstract

The ability to obtain a person’s whole genome sequence for a cost of one thousand dollars is nearly here. Many clinicians expect that this will usher in an era of personal medicine by allowing the development of individualized disease-risk profiles, preventive medicine strategies, and treatment options. It is not clear, however, that the regulatory strategy that currently controls the approval and availability of more limited genetic tests — typically meant to investigate a one or a small number of disease or other traits — provides a satisfactory framework for whole genome sequence testing.

This perspective takes the position that the generation of whole genome sequence information needs to be treated differently than the tests and results associated with more traditional diagnostic assays. First, it considers the current regulatory environment and efforts to reform the oversight of genetic tests, in particular, as they relate to the question of whether lay individuals should be permitted to order whole genome sequence tests without the guidance of a health-care professional. Second, the perspective discusses ways in which whole genome sequence tests differ from conventional genetic tests both in the vastly greater amount of information that is generated and in the ways that the information can be interpreted and reinterpreted for different purposes and at different times. Third, the perspective suggests that rather than concentrating on technical attributes of the whole genome sequence testing process, the approach currently used for standard genetic tests, regulatory approaches be directed to the tools needed to analyze and apply DNA sequence information. Such efforts will safeguard patients from adverse outcomes associated with unreliable disease-risk prediction and, at the same time, improve access to whole genome sequence testing and the benefits it may offer.

Keywords: whole genome sequencing, DNA, FDA, regulation

JEL Classification: K19, K23

Suggested Citation

Woodage, Trevor and Woodage, Trevor, Gatekeepers and Goalposts: The Need for a New Regulatory Paradigm for Whole Genome Sequencing Results (October 10, 2012). Northwestern Journal of Technology and Intellectual Property, Vol. 11, No. 1, 2012, Available at SSRN: https://ssrn.com/abstract=2159995

Trevor Woodage (Contact Author)

Fish & Richardson P.C. ( email )

3200 RBC Plaza
60 South Sixth St.
Minneapolis, MN 55402
United States

University of Minnesota - Twin Cities - School of Law ( email )

229 19th Avenue South
Minneapolis, MN 55455
United States

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