Biomarkers

Biomarker refers to a broad subcategory of medical signs – that is, objective indications of medical state observed from outside the patient – which can be measured accurately and reproducibly. Medical signs stand in contrast to medical symptoms, which are limited to those indications of health or illness perceived by patients themselves. It is characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention.

Examples of biomarkers include everything from pulse and blood pressure through basic chemistries to more complex laboratory tests of blood and other tissues.

The use of biomarkers in basic and clinical research as well as in clinical practice has become so commonplace that their presence as primary endpoints in clinical trials is now accepted almost without question. Biomarkers are by definition objective, quantifiable characteristics of biological processes. They may but do not necessarily correlate with a patient's experience and sense of wellbeing, and it is easy to imagine measurable biological characteristics that do not correspond to patients' clinical state, or whose variations are undetectable and without effect on health.

When used as outcomes in clinical trials, biomarkers are considered to be surrogate endpoints; that is, they act as surrogates or substitutes for clinically meaningful endpoints. But, not all biomarkers are surrogate endpoints, nor are they all intended to be. Surrogate endpoints are a small subset of well-characterized biomarkers with well-evaluated clinical relevance.

Characteristics of an ideal biomarker: An ideal biomarker has certain characteristics that make it appropriate for checking a particular disease condition. Ideally, an ideal marker should have the following features:

• Safe and easy to measure
• Cost efficient to follow up
• Modifiable with treatment
• Consistent across gender and ethnic groups

Biomarkers in cancer detection and drug development: The principles of biomarkers in disease have been applied to the detection, screening, diagnosis, treatment and monitoring of cancer. Traditionally, anti-cancer drugs were agents that killed both cancer cells and healthy cells. However, more targeted therapies have now been developed that can be directed to kill cancer cells only, while sparing healthy cells. The assessment of a typical biomarker in cancer helps in the development of therapies that can target the biomarker. This can minimize the risk of toxicity and reduce the cost of treatment. In cancer research, genetic studies are valuable because genetic abnormalities so often underlie the development of cancer. Certain DNA or RNA markers may therefore help in the detection and treatment of specific cancers.

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Journal of Clinical Chemistry and Laboratory Medicine
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