<n0:ComplexDefinition xmlns:n0="http://ncicb.nci.nih.gov/xml/owl/EVS/ComplexProperties.xsd#"><n0:def-definition>A biomarker that is measured in an analytical test system with well-established performance characteristics and for which there is widespread agreement in the medical or scientific community about the physiologic, toxicologic, pharmacologic, or clinical significance of the results (From: Pharmacogenomic Data Submissions, FDA Guidance for Industry.)</n0:def-definition><n0:def-source>FDA</n0:def-source></n0:ComplexDefinition>