Biomarkers

Definition

A biomarker is any measurable parameter (anatomic, physiologic, biochemical or molecular) that when assessed objectively can be used to monitor a normal or pathological physiological process, such as the onset of infection or disease, the response to medical intervention or relapse, or the body’s response to external environmental factors.

Biomarker measurements can range from relatively simple physiological indicators, such as blood pressure or heart rate, to more sophisticated molecular markers, such as presented by the prostate specific antigen (PSA, a marker for prostate cancer), or 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK, a marker of tobacco exposure).

Other published definitions of biomarkers include:

  • A characteristic that can be measured and evaluated as an indicator of normal biological processes, pathological processes or pharmacologic responses to therapeutic interventions (NIH Biomarkers Definitions Working Group, 1998)
  • A characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention (NIH Biomarker Definitions Working Group 2001)
  • Quantitative measures of biological effects that provide informative links between mechanism of action and clinical effectiveness (FDA whitepaper ‘Innovation or Stagnation’ 2004)
  • Any substance, structure or process that can be measured in the body or its products and can influence or predict the incidence of outcome of disease. (WHO International Programme on Chemical Safety)
  • Any characteristic that can be objectively measured and evaluated as an indicator of biological processes (either normal or pathogenic), or to evaluate pharmacological response to therapeutic intervention. (Boguslavsky 2004)

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