Re-overcoming barriers in translating biomarkers to clinical practice.

Importance Of The Field: 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.

Areas Covered In This Review: 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.

What The Reader Will Gain: The reader will get an introduction to strategies resolving actual barriers in clinical biomarker development.

Take Home Message: 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.