A biomarker (short for “biological marker”) is an objective measure that captures what is happening in a cell or an organism at a given moment. Biomarkers can serve as early warning systems for your health [1].
Image Credit: Research Advocacy Organization [2]
Formal definition of a biomarker
In 1998, the National Institutes of Health Biomarkers Definitions Working Group defined a biomarker 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"[3]. A joint venture on chemical safety, the International Programme on Chemical Safety, led by the World Health Organization (WHO) and in coordination with the United Nations and the International Labor Organization, has defined a biomarker as “any substance, structure, or process that can be measured in the body or its products and influence or predict the incidence of outcome or disease” [4]. An even broader definition considers not just incidence and outcome of disease, but also the effects of treatments, interventions, and even unintended environmental exposure, such as to chemicals or nutrients [5].
Examples of biomarkers
Biomarkers, diagnostics, and artificial intelligence
Biomarker evidence requirements
Regulation of biomarkers
Where to find out more
Romilly Life Sciences can offer several decades experience leading the validation, qualification and utilization of a range of novel biomarkers including brain function activity from MRI, breast cancer detection using microwave radar and machine learning to generate new imaging-based cancer endpoints for clinical trials.
To find out how we can help you commercially develop the next gold standard, contact us.
References
[2] https://researchadvocacy.org/sites/default/files/resources/BiomarkerValidationFinal-vDownload.pdf
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