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Level

Definition

I

Prospective, Marker Primary Objective,

Well-powered OR Meta-analysis, multi-

site

II

Prospective, Marker Secondary Objective

III

Retrospective, Outcomes, Multivariate

Analysis

IV

Retrospective, Outcomes, Univariate

V

Retrospective, Correlation with Other

Marker, No Outcomes

Levels of Evidence: Biomarker Qualification

Hayes, et al; J Nat Cancer Institute 88:1456, 1996; Simon R.M., et al. J Natl Cancer Inst. 2009