Barriers to Clinical Adoption of Next-Generation Sequencing: A Policy Delphi Panel’S Solutions

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.