Table 3.

Results That Should Be Reported in Various Phases of Biomarker Evaluation

Clinical validation

• The sensitivity and specificity of a technically validated biomarker, with fixed interpretation of the biomarker result, applied to the intended use population, as compared with the reference standard for the clinical application

• The clinical features of the cancer and control groups in clinical validation studies of the biomarker compared with the intended use population

• Biomarker results for relevant clinical subgroups

• Biomarker performance compared with and combined with clinical calculators, standard practice, and/or clinician judgment

Clinical utility

• The frequency with which the biomarker result impacts a clinical decision

• The impact (benefit and harm) of patient management decisions on patient outcomes when the biomarker is used

Cost-effectiveness

• The cost-effectiveness of the biomarker compared with the currently accepted standards for the clinical application