FIGURE 3-1 The steps of the evaluation framework are interdependent. While a validated test is required before qualification and utilization can be completed, biomarker uses inform test development, and the evidence suggests possible biomarker uses. In addition, the circle in the center signifies ongoing processes that should continually inform each step in the biomarker evaluation process.

FIGURE 3-1 The steps of the evaluation framework are interdependent. While a validated test is required before qualification and utilization can be completed, biomarker uses inform test development, and the evidence suggests possible biomarker uses. In addition, the circle in the center signifies ongoing processes that should continually inform each step in the biomarker evaluation process.

panels of biomarkers in addition to single biomarkers and for both circulating and imaging biomarkers. While the report provides case studies of individual biomarkers, the committee concluded that sets of biomarkers need to be qualified using the same process. In some cases, individual biomarkers within the same set may need to be qualified individually.

This chapter explores the rationale behind the committee’s decision to separate evaluation into three interrelated steps before providing an in-depth examination of each step. This conceptual framework is meant to provide a clear, adaptable platform for statistically sound, evidence-based biomarker evaluation.



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