CENTER OF EXCELLENCE IN BIOMARKER RESEARCH & INDIVIDUALIZED MEDICINE (SCHOOL OF BRIM)

What are Biomarkers?

dna

 

 DEFINITION

  • NIH Biomarkers Definitions Working Group: “A characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention.”
  • World Health Organization: “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.”

EXAMPLES

  • Strimbu & Tavel: “Everything from pulse and blood pressure through basic chemistries to more complex laboratory tests of blood and other tissues.”
  • The BRIM Center is most interested in macromolecular biomarkers, including DNA (genetic polymorphisms or differences in methylation status), RNA (transcript levels or splicing variants), and protein (polypeptide levels or modification status).

VALIDATION

  • “The key issue at hand is determining the relationship between any given measurable biomarker and relevant clinical endpoints.”
  • “Biomarkers could only serve as true replacements for clinical relevant endpoints if we completely understood the normal physiology of a biological process, the pathophysiology of that process in the disease state, and effects of an intervention… Since we rarely if ever have the full picture of those types of processes… biomarkers as surrogate endpoints need constant reevaluation.”
Last Updated: 6/29/17