A policy approach to the development of molecular diagnostic tests |
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| Authors: | Schulman Kevin A Tunis Sean R |
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| Affiliation: | 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.schulman@duke.edu |
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| Abstract: | 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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