Strategic paths for biomarker qualification
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Updated: Jul 7, 2026
Selecting Multiple Biomarker Subsets with Similarly Effective Binary Classification Performances
Published on: October 11, 2018
Federico M Goodsaid1, Felix W Frueh, William Mattes
1Genomics Group, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, FDA, MD 20903-0002, United States. Federico.Goodsaid@fda.hhs.gov
Abstract:
Biomarkers may be qualified using different qualification processes. A passive approach for qualification has been to accept the end of discussions in the scientific literature as an indication that a biomarker has been accepted. An active approach to qualification requires development of a comprehensive process by which a consensus may be reached about the qualification of a biomarker. Active strategies for qualification include those associated with context-independent as well as context-dependent qualifications.
