Modernizing US regulatory and reimbursement policy to support continued innovation in genomic pathology

Sheila D. Walcoff, John D. Pfeifer

Research output: Contribution to journalReview articlepeer-review

9 Scopus citations


The pace of technical and scientific advancement for genomics-based technologies has outstripped the ability of the US regulatory bodies to keep abreast of the emerging paradigms, resulting in regulatory pronouncements that often appear dated and payment systems that are misaligned. Over burdensome evidentiary requirements, encroachment of federal regulators into the practice of laboratory medicine, and failure to align public health objectives with pay or valuation sufficient to support professional pathology services and necessary capital investment threaten to stifle continued innovation in genomic-based diagnostic tools. Nevertheless, the US FDA is committed to improving regulatory science and to increased stakeholder participation in policy-making, and serious efforts to address coding and test value are underway. Moreover, federal legislation will be debated in the coming months that, if enacted, could clarify authorities and institute meaningful regulatory and reimbursement paradigms better suited to molecular testing. This review explores these dynamic policy issues and their implications for genomic pathology as the foundation of personalized medicine.

Original languageEnglish
Pages (from-to)295-308
Number of pages14
JournalPersonalized Medicine
Issue number3
StatePublished - May 2012


  • LDT
  • RUO
  • US FDA
  • biomarker
  • genomic pathology
  • in vitro diagnostic
  • molecular
  • personalized medicine
  • regulation
  • reimbursement


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