Covers evaluation of biomarkers for diagnosis; decision-theoretic assessment tools; measures of the incremental value of a new biomarker; evaluation of risk prediction models; evaluation of biomarkers for prognosis or for guiding therapy; statistical learning for developing a diagnostic/prognostic score; and clinical trial designs for biomarker guided decisions. Prerequisites: BIOST 515; either BIOST 518 or both BIOST 512 and BIOST 513; or equivalent.