Barriers to clinical adoption of next generation sequencing: Perspectives of a policy Delphi panel

Donna A. Messner, Jennifer Al Naber, Pei Koay, Robert Cook-Deegan, Mary Majumder, Gail Javitt, Patricia Deverka, Rachel Dvoskin, Juli Bollinger, Margaret Curnutte, Subhashini Chandrasekharan, Amy McGuire

    Research output: Contribution to journalArticle

    14 Scopus citations

    Abstract

    This research aims to inform policymakers by engaging expert stakeholders to identify, prioritize, and deliberate the most important and tractable policy barriers to the clinical adoption of next generation sequencing (NGS). A 4-round Delphi policy study was done with a multi-stakeholder panel of 48 experts. The first 2 rounds of online questionnaires (reported here) assessed the importance and tractability of 28 potential barriers to clinical adoption of NGS across 3 major policy domains: intellectual property, coverage and reimbursement, and FDA regulation. We found that: 1) proprietary variant databases are seen as a key challenge, and a potentially intractable one; 2) payer policies were seen as a frequent barrier, especially a perceived inconsistency in standards for coverage; 3) relative to other challenges considered, FDA regulation was not strongly perceived as a barrier to clinical use of NGS. Overall the results indicate a perceived need for policies to promote data-sharing, and a desire for consistent payer coverage policies that maintain reasonably high standards of evidence for clinical utility, limit testing to that needed for clinical care decisions, and yet also flexibly allow for clinician discretion to use genomic testing in uncertain circumstances of high medical need.

    Original languageEnglish (US)
    Pages (from-to)19-24
    Number of pages6
    JournalApplied and Translational Genomics
    Volume10
    DOIs
    StatePublished - Sep 1 2016

    Keywords

    • Clinical genomics
    • Coverage and reimbursement
    • FDA regulation
    • Intellectual property
    • Next generation sequencing
    • Personalized medicine

    ASJC Scopus subject areas

    • Biotechnology
    • Molecular Biology
    • Pharmaceutical Science

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  • Cite this

    Messner, D. A., Al Naber, J., Koay, P., Cook-Deegan, R., Majumder, M., Javitt, G., Deverka, P., Dvoskin, R., Bollinger, J., Curnutte, M., Chandrasekharan, S., & McGuire, A. (2016). Barriers to clinical adoption of next generation sequencing: Perspectives of a policy Delphi panel. Applied and Translational Genomics, 10, 19-24. https://doi.org/10.1016/j.atg.2016.05.004