TABLE 3.

Institute of Medicine biomarker-evaluation process¹

Step	Description
1) Analytic validation	Analysis of available evidence on the analytic performance of an assay
	Measurements are accurate across time, laboratories, and assays
	Measurements possess adequate sensitivity and specificity for their intended use
2) Qualification	Assessment of available evidence on associations between the biomarker and disease states including data showing effects of interventions on both the biomarker and clinical outcomes
	An evaluation of the biomarker’s prognostic value
	Evidence showing that the intervention targeting the biomarker actually affects the clinical endpoint of interest
	Evidence that the relation between the biomarker and clinical outcome persists across multiple interventions
3) Utilization	Contextual analysis that is based on the specific use proposed and the applicability of available evidence to this use, which includes a determination of whether the analytic validation and qualification conducted provide sufficient support for the use proposed
	Define the purpose and context of use for the intended biomarker
	Assess the potential benefits and harms of the biomarker for its proposed use
	Identify the tolerability of risk for the biomarker within the proposed purpose and context of use
	Assess the evidentiary status of the biomarker

¹From reference 1.