Barriers to clinical adoption of next-generation sequencing: a policy Delphi panel's solutions. (July 2017)

• Record Type: Journal Article
• Authors: Messner, Donna A; Koay, Pei; Naber, Jennifer Al; Cook-Deegan, Robert; Majumder, Mary; Javitt, Gail; Dvoskin, Rachel; Bollinger, Juli; Curnutte, Margaret; McGuire, Amy L
• Is Part Of: Personalized medicine. Volume 14:Number 4(2017)
• Page Start: 339
• Page End: 354
• Publication Date: 2017-07
• Subjects: clinical data reporting -- clinical genomics -- coverage and reimbursement -- intellectual property -- next-generation sequencing -- personalized medicine -- policy -- regulation; Pharmacogenomics -- Periodicals; Pharmacogenetics -- Periodicals; 615.19
• DOI: 10.2217/pme-2016-0104
• Languages: English
• ISSNs: 1741-0541

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.