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A policy approach to the development of molecular diagnostic tests

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Efficiently generating evidence of clinical utility is a major challenge for ensuring clinical adoption of valuable diagnostics. A new approach to reimbursement in the United States offers a balance between evidence and incentives for molecular diagnostic tests.

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Authors and Affiliations

  1. Kevin A. Schulman is at the Duke Clinical Research Institute, Duke University School of Medicine and the Health Sector Management Program, The Fuqua School of Business, Duke University, Durham, North Carolina, USA.,

    Kevin A Schulman

  2. Sean R. Tunis is at the Center for Medical Technology Policy, Baltimore, Maryland, USA.,

    Sean R Tunis

Authors
  1. Kevin A Schulman
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  2. Sean R Tunis
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Correspondence to Kevin A Schulman.

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Competing interests

K.A.S. received research support from Actelion Pharmaceuticals, Allergan, Amgen, Astellas Pharma, Bristol-Myers Squibb, The Duke Endowment, Genentech, Inspire Pharmaceuticals, Johnson & Johnson, Kureha Corporation, LifeMasters Supported SelfCare, Medtronic, Merck & Co., Nabi Biopharmaceuticals, National Patient Advocate Foundation, North Carolina Biotechnology Center, NovaCardia, Novartis, OSI Eyetech, Pfizer, Sanofi-aventis, Scios, Tengion, Theravance, Thomson Healthcare and Vertex Pharmaceuticals; personal income for consulting from McKinsey & Company and the National Pharmaceutical Council; had equity in Alnylam Pharmaceuticals; had equity in and served on the board of directors of Cancer Consultants, Inc; and had equity in and serving on the executive board of Faculty Connection. K.A.S. has made available online a detailed listing of financial disclosures (http://www.dcri.duke.edu/research/coi.jsp). S.R.T. is an employee of the Center for Medical Technology Policy (CMPT), a nonprofit policy and research center that works on issues of comparative effectiveness research and coverage with evidence development. CMPT receives funding from a range of health plans, life sciences companies, foundations and government grants.

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Schulman, K., Tunis, S. A policy approach to the development of molecular diagnostic tests. Nat Biotechnol 28, 1157–1159 (2010). https://doi.org/10.1038/nbt1110-1157

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