International COVID-19 biomarkers colloquium

Excerpt

The Food and Drug Administration defines a biomarker as a laboratory measure or a physical sign that is used in therapeutic trials as a substitute for a clinically meaningful endpoint that is a direct measure of how a patient feels, functions, or survives, and is expected to predict the effect of the therapy [1]. In 1998, the National Institutes of Health Biomarkers Definitions Working Group added a dimension to this definition, and included that a biomarker is: “a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention”. The World Health Organization offers a definition in the context of exposures, including environmental effects on human health and disease- a biomarker is a chemical, its metabolite, or the product of an interaction between a chemical and some target molecule or cell that is measured in the human body (www.​who.​org accessed 29 October 2021). Collectively, the ideal biomarker offers sensitivity, specificity, and is readily available at a low cost. As with most test platforms, biomarkers should provide a “value add” for specific patients and clinical scenarios to achieve optimal patient care (Fig. 1) [2].

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