title: Re-overcoming barriers in translating biomarkers to clinical practice.
abstract: BACKGROUND
  Recently, there has been growing evidence for the concept of personalized medicine as the implementation of genomic and molecular information in the delivery of healthcare. In parallel, the identification of biomarkers has become of enormous significance as a prerequisite for individualized intervention regimens.
  
  
  METHODS
  Biomarkers are developed to improve prevention, diagnosis or therapeutic outcome of a given disease. Although each application reveals distinct developmental strategies, evidence-based approval of new biomarkers is important for the success of new drugs, diagnostic tests or recommendations in preventive medicine. Current hurdles to bringing biomarkers into clinical practice are reviewed, thereby focusing on adequate approaches to overcome these limitations in the future.
  
  
  RESULTS
  The reader will get an introduction to strategies resolving actual barriers in clinical biomarker development.
  
  
  CONCLUSIONS
  The identification of evidence-based biomarkers is crucial for the success of individualized therapeutic approaches. Developmental strategies have to be adapted to clinical need, thereby focusing on biomarker validation in clinical settings as well as on the establishment of standardized biomarker test systems for routine application. Consortia have been established bringing together representatives of government, academia and industry to improve future biomarker development.
authors.affiliation: University of Bonn, Genomics and Immunoregulation, LIMES (Life and Medical Sciences Bonn), Program Unit Molecular Immune and Cell Biology, Carl Troll Str. 31, D-53115 Bonn, Germany +49 228 73 62779 ; +49 228 73 62646 ; starat@uni-bonn.de.
authors.forename: Andrea
authors.initials: A
authors.lastname: Staratschek-Jox
authors.forename: Joachim L
authors.initials: JL
authors.lastname: Schultze