Biomarkers are a subcategory of medical signs that can be objectively measured or detected through different tests and procedures. Examples of biomarkers include: blood pressure and body temperature (physiological biomarkers); LDL cholesterol level and red blood cell count (molecular biomarkers); and tumor detected by contrast MRI or bone fracture detected by X-ray (imaging biomarkers). Biomarkers can also be categorized by what they measure. For example, there are biomarkers that might detect who is at risk for developing a disease.
Biomarkers can be used to establish a diagnosis, monitor disease progression, predict complications or disease recurrence, or designate who might benefit most from a specific treatment. Specific biomarkers can also measure response to a treatment. Biomarkers are important for the development of drugs, biologics, and certain medical devices.
Glossary from “BEST (Biomarkers, EndpointS, and other Tools) Resource” [Internet].
U.S. Food and Drug Administration (FDA): Patient-Focused Drug Development Glossary
NCATS Toolkit for Patient-Focused Therapy Development: Biomarker
U.S. Food and Drug Administration (FDA): About Biomarkers and Qualification