The clinical integration of next generation sequencing (NGS) has brought to light challenging policy concerns such as oversight of test quality and services, patenting and licensing issues, privacy and data sharing, and insurance coverage and reimbursement. A team of legal and policy experts came together to identify, prioritize and deliberate the most important and tractable policy barriers and solutions to the clinical adoption of NGS.
This involved three major research activities:
- Landscape analysis of current and emerging NGS companies and qualitative interviews with industry leaders, to understand how the industry is developing in an uncertain policy climate (see Nature Biotechnology publication and check out the list of next generation sequencing companies we developed using crowdsourcing methods).
- Legal analysis of key policy issues related to regulation, reimbursement, intellectual property and data sharing (see Journal of Law, Medicine & Ethics special issue).
- Modified Delphi process involving a series of four surveys to identify and prioritize the unique policy challenges involved in translating the health benefits of NGS (see Applied & Translational Genomics publication).
Supported by: R01HG006460, National Human Genome Research Institute, NIH
Amy L. McGuire, J.D., Ph.D., Principal Investigator
Subhashini Chandrasekharan, Ph.D., Co-Investigator
Robert M. Cook-Deegan, M.D., Co-Investigator
Gail H. Javitt, J.D., M.P.H., Co-Investigator
Mary Anderlik Majumder, J.D. Ph.D., Co-Investigator
Donna A. Messner, Ph.D., Co-Investigator
Guerrini CJ, McGuire AL, Majumder MA, Bollinger JS, Rowan PJ. Constraints on Gene Patent Protection Fuel Secrecy Concerns: A Qualitative Study, J. Law & Biosciences 4(3), 2017: 542-564.
Guerrini CJ, McGuire AL, Majumder MA. Myriad Take Two: Can Private Genomic Databases Remain Secret? Science 356(6338), 2017: 586-587.
Curnutte MA, Frumovitz KL, Bollinger JM, Cook-Deegan RM, McGuire AL, Kaufman DJ, Majumder MA. Developing context-specific next-generation sequencing policy. Nat Biotechnol 34, 2016: 466-470.
Messner DA, Naber JA, Koay P, Cook-Deegan R, Majumder M, et al. Barriers to clinical adoptions of next generation sequencing: Perspectives of a policy Delphi panel. Appl Trans Genom 10, 2016: 19-24.
Guerrini CJ, Majumder M, McGuire AL. Persistent confusion and controversy surrounding gene patents. Nat Biotechnol 34(2), 2016: 145-7.
Deverka PA, Kaufman D, McGuire AL. Overcoming the Reimbursement Barriers for Clinical Sequencing. JAMA 312(18), 2014: 1857-1858.
Special Issue for the Journal of Law, Medicine & Ethics 42(3), 2014 includes articles from:
- Amy McGuire, Margaret Curnutte, and David Kaufman. Clinical Integration of Next Generation Sequencing: A Policy Analysis
- Gail Javitt and Katherine S. Carner. Regulation of Next Generation Sequencing
- Patricia Deverka and Jennifer Dreyfus. Clinical Integration of Next Generation Sequencing: Coverage and Reimbursement Challenges
- Robert Cook-Deegan and Subhashini Chandrasekharan. Patents and Genome-Wide DNA Sequence Analysis: Is it Safe to Go into the Genome?
- Barbara J. Evans. Economic Regulation of Next-Generation Sequencing
Curnutte MA, Frumovitz KL, Bollinger JM, McGuire AL, Kaufman DJ. Development of the Clinical NGS Industry in a Shifting Policy Climate. Nature Biotechnology 32(10), 2014: 980-982.
Chandrasekharan S, McGuire AL, Van den Veyver IB. Do Recent US Supreme Court Rulings on Patenting of Genes and Genetic Diagnostics Affect the Practice of Genetic Screening and Diagnosis in Prenatal and Reproductive Care? Prenatal Diagn 34(10), 2014: 921-926.
Guerrini C. The New Landscape of Patent Eligibility: Empirical Findings. BioCanRx Summit for Cancer Immunotherapy. Ottawa, ON. June 2017.
Guerrini C. The New Legal Landscape of Genomics Patents: A Qualitative Study. The American Society of Human Genetics Annual Meeting, Washington, DC. October 2016.
McGuire AL, Kaufman DJ, Javitt GH, Deverka PA, Messner D, Cook-Deegan R, Curnutte MA, Bollinger J, Dvoskin R, Chandrasekharan S, Evans BJ. Clinical Integration of NGS: A Policy Analysis. The American Society of Human Genetics Annual Meeting, San Diego, CA. October 2014.
Curnutte MA, Frumovitz KL, Bollinger J, McGuire AL, Kaufman DJ. Tracking the Development of the Clinical Next Generation Sequencing Industry. The American Society of Human Genetics Annual Meeting, San Diego, CA. October 2014.
McGuire AL. Stakeholder Views of Regulatory Issues Related to Next Generation Sequencing. Legal Issues in Genomic Medicine Session, Clinical Sequencing Exploratory Research (CSER) Meeting, Bethesda, MD. October 2014.
Curnutte MA. The Next Generation Sequencing Industry: A Critique of the Policy-Lag Narrative. 13th Annual Science & Democracy Network Meeting, Vienna, Austria, June 2014. Department of Social Science, Health & Medicine, King’s College London, United Kingdom. June 2014.
Curnutte MA. Genetic Information in Context. Center for Genomics and Society, University of North Carolina, Chapel Hill, NC. April 2014.
Curnutte MA. Development of the Clinical NGS Industry in a Shifting Policy Climate. Clinical Genetics Conference, sponsored by Baylor College of Medicine, Houston, TX. April 2014.
Curnutte MA. Genetic Information is as Genetic Information Does. American Anthropological Association Annual Meeting, Chicago, IL. November 2013.
Curnutte MA, Frumovitz KL, Bollinger J, Javitt GH, Carner KS, Cook-Deegan R, Chandrasekharan S, Messner D, Deverka P, Kaufman DJ, McGuire AL. Mapping the Next Generation Sequencing Industry. The American Society of Human Genetics Annual Meeting, Boston, MA. October 2013.
Curnutte MA. Mapping the Next Generation Sequencing Industry. The Clinical Genome Conference, San Francisco, CA. June 2013.