Barriers to clinical adoption of nextgeneration sequencing: A policy Delphi panel's solutions

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

    Research output: Contribution to journalArticlepeer-review

    6 Scopus citations

    Abstract

    Aim: Identify solutions to the most important policy barriers to the clinical adoption of next-generation sequencing. Materials & methods: Four-round modified policy Delphi with a multistakeholder panel of 48 experts. The panel deliberated policy solutions to (previously reported) challenges deemed most important to address. Results: The group advocated using consensus panels to promote consistency in payer policies and to standardize test reporting, and favored making genomic data-sharing a condition of regulatory clearance, certification, or accreditation processes. They were split on the role of US FDA. Conclusion: Panelists found common ground on solutions for health plan coverage policy consistency, data-sharing, and standardizing reporting, but were sharply divided on the role of the FDA in mitigating risks to patients.

    Original languageEnglish (US)
    Pages (from-to)339-354
    Number of pages16
    JournalPersonalized Medicine
    Volume14
    Issue number4
    DOIs
    StatePublished - Jul 2017

    Keywords

    • Clinical data reporting
    • Clinical genomics
    • Coverage and reimbursement
    • Intellectual property
    • Next-generation sequencing
    • Personalized medicine
    • Policy
    • Regulation

    ASJC Scopus subject areas

    • Molecular Medicine
    • Pharmacology

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