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Updated: Apr 22, 2026

Targeted Next-generation Sequencing and Bioinformatics Pipeline to Evaluate Genetic Determinants of Constitutional Disease
Published on: April 4, 2018
Clinical integration of next generation sequencing: a policy analysis
David Kaufman1, Margaret Curnutte, Amy L McGuire
1Director of Research at the Genetics and Public Policy Center at Johns Hopkins University in Washington, D.C.
Abstract:
Clinical next generation sequencing (NGS) technologies are challenging existing regulatory paradigms. We advocate a coordinate policy approach, which first requires a comprehensive understanding of the existing regulatory and legal structures. This paper introduces four key policy domains - including quality assurance, insurance coverage, intellectual property management, and data sharing - that must be addressed to ensure high quality clinical NGS. In bringing these policy issues into conversation through this special issue for the Journal of Law, Medicine & Ethics, we hope to lay the foundation for further discussion by a range of stakeholder groups with diverse and strong interests in the governance of NGS.
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