BIOMARKERS

A biomarker is in general is a substance used as an indicator of a biological state, biological processes, pathogenic processes or pharmacological response to a therapeutic intervention, hence it is used in many scientific fields. In cell biology, a biomarker is a molecule that allows for the detection and isolation of a particular cell type (for example, the protein Oct-4 is used as a biomarker to identify embryonic stem cells). In genetics, a biomarker (identified as genetic marker) is a DNA sequence that causes disease or is associated with susceptibility to disease.

 In the fields of geology and astrobiology, A biomarker can be any kind of molecule indicating the existence, past or present, of living organisms. In Medicins: In medicine, a biomarker is a term often used to refer to a protein, measured in blood whose concentration reflects the severity or presence of some disease state. More generally a biomarker is anything that can be used as an indicator of a particular disease state or some other physiological state of an organism. In medicines it can be a traceable substance that is introduced into an organism as a mean to examine organ function or other aspects of health.

 It can also be used as a substance whose detection indicates a particular disease state, for example: rubidium chloride is used as a radioactive isotope to evaluate perfusion of heart muscle. It can also be a substance whose detection indicates a particular disease state, for example: the presence of an antibody may indicate an infection.
Biomarkers can be specific cells, molecules, or genes, gene products, enzymes, or hormones. Complex organ functions or general characteristic changes in biological structures can also serve as biomarkers. Although the term biomarker is relatively new, biomarkers have been used in pre-clinical research and clinical diagnosis for a considerable time.For example, body temperature is a well-known biomarker for fever.

Biomarker classification and application Biomarkers can be classified based on different parameters. They can be classified based on their characteristics such as imaging biomarkers (CT, PET, MRI) or molecular biomarkers. Biomarkers can also be classified based on their application such as diagnostic biomarkers (i.e., cardiac troponin for the diagnosis of myocardial infarction), staging of disease biomarkers (i.e., brain natriuretic peptide for congestive heart failure), disease prognosis biomarkers (cancer biomarkers), and biomarkers for monitoring the clinical response to an intervention . Another category of biomarkers includes those used in decision making in early drug development. For instance, pharmacodynamic (PD) biomarkers are markers of a certain pharmacological response, which are of special interest in dose optimization studies.

Potential Disadvantages Not all biomarkers should be used as surrogate(substitute) endpoints to assess clinical outcomes. Biomarkers can be difficult to validate and require different levels of validation depending on their intended use.

Blood pressure is used to determine the risk of stroke. It is also widely known that cholesterol values are a biomarker and risk indicator for coronary and vascular disease, and that Creactive protein (CRP) is a marker for inflammation. A biomarker is a parameter that can be used to measure the progress of disease or the effects of treatment. The parameter can be chemical, physical or biological. Several diseased based biomarker had been identified for many diseases such as serum LDL for cholesterol, blood pressure, P53 gene and MMPs for cancer etc.
Significance of biomarkers in drug development Once a proposed biomarker has been validated, it can be used to diagnose disease risk, presence of disease in an individual, or to tailor treatments for the disease in an individual (choices of drug treatment )

 In evaluating potential drug therapies, a biomarker may be used as a surrogate for a natural endpoint such as survival or irreversible morbidity (diseased state). Some of the main areas in which molecular biomarkers are used in the drug development process are: Early drug development studies, Safety studies, Proof of concept studies, Molecular profiling.