Record Details

Gatekeepers or Intermediaries? The Role of Clinicians in Commercial Genomic Testing

ScholarsArchive at Oregon State University

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Title Gatekeepers or Intermediaries? The Role of Clinicians in Commercial Genomic Testing
Names McGowan, Michelle L. (creator)
Fishman, Jennifer R. (creator)
Settersten, Richard A., Jr. (creator)
Lambrix, Marcie A. (creator)
Juengst, Eric T. (creator)
Date Issued 2014-09-26 (iso8601)
Note This is the publisher’s final pdf. The published article is copyrighted by the author(s) and published by the Public Library of Science. The published article can be found at: http://www.plosone.org/.
Abstract BACKGROUND: Many commentators on ‘‘direct-to-consumer’’ genetic risk information have raised concerns that giving results
to individuals with insufficient knowledge and training in genomics may harm consumers, the health care system, and
society. In response, several commercial laboratories offering genomic risk profiling have shifted to more traditional ‘‘direct-to-provider’’ (DTP) marketing strategies, repositioning clinicians as the intended recipients of advertising of laboratory
services and as gatekeepers to personal genomic information. Increasing popularity of next generation sequencing puts a
premium on ensuring that those who are charged with interpreting, translating, communicating and managing commercial
genomic risk information are appropriately equipped for the job. To shed light on their gatekeeping role, we conducted a
study to assess how and why early clinical users of genomic risk assessment incorporate these tools in their clinical practices
and how they interpret genomic information for their patients.
METHODS and FINDINGS: We conducted qualitative in-depth interviews with 18 clinicians providing genomic risk assessment
services to their patients in partnership with DNA Direct and Navigenics. Our findings suggest that clinicians learned most of
what they knew about genomics directly from the commercial laboratories. Clinicians rely on the expertise of the
commercial laboratories without the ability to critically evaluate the knowledge or assess risks.
CONCLUSIONS: DTP service delivery model cannot guarantee that providers will have adequate expertise or sound clinical
judgment. Even if clinicians want greater genomic knowledge, the current market structure is unlikely to build the
independent substantive expertise of clinicians, but rather promote its continued outsourcing. Because commercial
laboratories have the most ‘‘skin in the game’’ financially, genetics professionals and policymakers should scrutinize the
scientific validity and clinical soundness of the process by which these laboratories interpret their findings to assess whether
self-interested commercial sources are the most appropriate entities for gate-keeping genomic interpretation.
Genre Article
Access Condition http://creativecommons.org/licenses/by/3.0/us/
Identifier McGowan, M. L., Fishman, J. R., Settersten, R. A. Jr, Lambrix, M. A., Juengst, E. T. (2014). Gatekeepers or Intermediaries? The Role of Clinicians in Commercial Genomic Testing. PLoS ONE, 9(9), e108484. doi:10.1371/journal.pone.0108484

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