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.