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

Research paper by Donna A DA Messner, Pei P Koay, Jennifer J Al Naber, Robert R Cook-Deegan, Mary M Majumder, Gail G Javitt, Rachel R Dvoskin, Juli J Bollinger, Margaret M Curnutte, Amy L AL McGuire

Indexed on: 13 Dec '17Published on: 13 Dec '17Published in: Personalized medicine


Identify solutions to the most important policy barriers to the clinical adoption of next-generation sequencing.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.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.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.