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The US National Institutes of Health (NIH) and Food and Drug Administration (FDA) define “biomarker” as “a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes or responses to an exposure or intervention” (Califf 2018). In practice, a biomarker is a measurable endpoint that can be found in body fluids or tissues as the indicator of exposure, infection, or disease. Biomarkers are used in clinical practice. They play important critical roles in the development of drugs and medical devices (Robb et al. 2016).

The new “omics” technology provides genomic and epigenomic tools for the development of biomarkers for predicting toxicity and disease. However, these biomarkers must be validated, and that is not easy. Almost a decade ago, Janet Woodcock (2009) warned that “to deliver a new generation of biomarkers to clinical practice will be long and hard.” In spite of her warning, a lot of progress has been made in the discovery of genomic and epigenomic biomarkers for toxicity and disease during the last decade. But unfortunately no single biomarker is expected to provide most of the information required for toxicity and disease. Therefore a battery of biomarkers is desirable for this purpose.