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Biomarkers are biomolecules that correlate with and/or predict a physiological or disease state and can be measured quantitatively or semi-quantitatively. Since evaluation of clinical responses and/or outcome is often hampered by subjectivity, variability and prohibitive timelines, biomarkers that reliably correlate with and/or predict physiological or pathological processes are sought intensively in fundamental and applied biomedical research and development. For easy access and reliable measurements, biomarkers ideally should be present in plasma and/or urine; however, access to disease biomarkers, specifically in cancer, often requires retrieval of tissue biopsies.
Well-known examples of clinically relevant biomarkers are alpha-fetoprotein in liver cancer, prostate-specific antigen in prostate cancer, and troponin in heart-disease. The easiest and most-cost-effective way for biomarker measurements is through ELISA-type assays, while biomarkers in tissue biopsies are often visualized through immunohistochemistry. Biomarkers are usually discovered and characterized in disease-relevant animal models.
Clinical validation of the surrogate or predictive value of a presumptive biomarker for a certain disease state is most often a costly and high-risk undertaking, and the FDA thus far has approved only a few biomarkers as surrogate endpoints in registration trials.