title: Sensitivity, Specificity, PPV, and NPV for Predictive Biomarkers.
abstract: Molecularly targeted cancer drugs are often developed with companion diagnostics that attempt to identify which patients will have better outcome on the new drug than the control regimen. Such predictive biomarkers are playing an increasingly important role in precision oncology. For diagnostic tests, sensitivity, specificity, positive predictive value, and negative predictive are usually used as performance measures. This paper discusses these indices for predictive biomarkers, provides methods for their calculation with survival or response endpoints, and describes assumptions involved in their use.
authors.affiliation: Richard Simon, DSc, National Cancer Institute, Rockville MD. rsimon@nih.gov.
authors.forename: Richard
authors.initials: R
authors.lastname: Simon
mesh_terms: D000970:Antineoplastic Agents / Q000494:pharmacology; D014408:Biomarkers, Tumor; D006801:Humans; D008432:Mathematical Computing; D058990:Molecular Targeted Therapy / Q000379:methods; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor