Analytical and clinical evaluation of biomarkers assays: when are biomarkers ready for prime time?

@article{Pennello2013AnalyticalAC,
  title={Analytical and clinical evaluation of biomarkers assays: when are biomarkers ready for prime time?},
  author={Gene A. Pennello},
  journal={Clinical trials},
  year={2013},
  volume={10 5},
  pages={666-76}
}
BACKGROUND Biomarker assays can be evaluated for analytical performance (ability of assay to measure the biomarker quantity) and clinical performance (ability of assay result to inform of the clinical condition of interest). Additionally, a biomarker assay is said to have clinical utility if it ultimately improves patient outcomes when used as intended. PURPOSE This article reviews analytical and clinical performance studies of biomarker assay tests and also some designs of clinical utility… CONTINUE READING

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