Molecular pathology

► Diverse laboratory methodologies are available for various analytes, often making test development problematical. ► Integral marker clinical trials and standard-of-care applications must employ regulatory-compliant biomarkers. ► The Institute of Medicine of the National Academies in the United States has produced a comprehensive review of omics-based tests. ► Understanding of aberrations along molecular pathways and of intratumoral heterogeneity are key to successful use of biomarkers.