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 journalArticle

5 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 1 2017

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Keywords

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

ASJC Scopus subject areas

  • Medicine(all)
  • Molecular Medicine
  • Pharmacology

Cite this

Messner, D. A., Koay, P., Al Naber, J., Cook-Deegan, R., Majumder, M., Javitt, G., Dvoskin, R., Bollinger, J., Curnutte, M., & McGuire, A. L. (2017). Barriers to clinical adoption of nextgeneration sequencing: A policy Delphi panel's solutions. Personalized Medicine, 14(4), 339-354. https://doi.org/10.2217/pme-2016-0104