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Biomarker

Molecular classification
General category
01

Overview

A biomarker, or biological marker, is a general term for a measurable indicator of a biological state or condition. It is defined by the NIH and FDA as 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/FDA BEST Resource, 2016). Biomarkers can encompass a wide array of entities, including specific proteins, genetic mutations, metabolites, or physiological measurements such as blood pressure or heart rate. They are essential in modern medicine for diagnosing diseases, predicting disease progression, and identifying patients most likely to respond to specific therapies (Strimbu & Tavel, 2010). Because the term 'Biomarker' describes a broad class of indicators rather than a specific protein, receptor, or enzyme, it is not considered a therapeutic target in itself. Instead, it serves as a fundamental concept in clinical research and drug development to evaluate the interaction between a drug and its intended molecular target.

Other names
Biological marker
02

Mechanism of action

Not applicable as this is a broad category of clinical/biological indicators and not a specific molecular target.

03

Biological functions

Indicator of biological processesIndicator of pathogenic processesIndicator of pharmacologic response
04

Disease associations

DiagnosticsPrognosticsPredictive medicineSafety monitoring
05

Safety considerations

Misinterpretation of clinical dataLack of clinical validationLow sensitivity or specificity

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