A policy approach to the development of molecular diagnostic tests

Nat Biotechnol. 2010 Nov;28(11):1157-9. doi: 10.1038/nbt1110-1157.


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.

MeSH terms

  • Biomarkers / analysis
  • Humans
  • Molecular Diagnostic Techniques / economics*
  • Molecular Diagnostic Techniques / methods*
  • Policy*
  • Reimbursement Mechanisms
  • United States


  • Biomarkers