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A cancer biomarker is a biological molecule found in blood, other body fluids, or tissues that serves as a sign of a normal or abnormal process, or of a condition or disease such as cancer [1]. These markers encompass a wide range of substances, including DNA, RNA, proteins, and metabolites, which can be used for screening, diagnosis, characterization, and monitoring of cancer progression or response to therapy [2]. Because the term refers to a broad functional category rather than a specific protein, enzyme, or receptor, it is not considered a single therapeutic target. Instead, specific biomarkers like Human epidermal growth factor receptor 2 (HER2) or BCR-ABL may serve as targets for precision medicine, but the collective term 'cancer biomarker' lacks the molecular specificity required for drug development. Consequently, while vital for clinical decision-making and patient stratification, it does not possess a singular mechanism of action or a defined set of interacting drugs. The identification and validation of these markers are critical for the development of companion diagnostics that guide the use of targeted therapies. However, using the general term as a target name is incorrect in a pharmacological context because it does not identify a unique site of drug action. [1] National Cancer Institute (NCI) Dictionary of Cancer Terms. [2] FDA-NIH Biomarker Working Group, BEST (Biomarkers, EndpointS, and other Tools) Resource.
Not applicable. 'Cancer biomarker' is a general term for a category of indicators rather than a specific molecular target for drug action.
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