Biomarkers

Biomarker(s) is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. Also called molecular marker and signature molecule.2

Susceptibility/Risk Biomarker

A biomarker that indicates the potential for developing a disease or medical condition in an individual who does not currently have clinically apparent disease or the medical condition.1
Example: Germline BRCA1 PV, inform about future cancer risks

Diagnostic Biomarker

A biomarker used to detect or confirm presence of a disease or condition of interest or to identify individuals with a subtype of the disease.1
Example: HER2 expression in breast cancer

Monitoring Biomarker

A biomarker measured serially for assessing status of a disease or medical condition or for evidence of exposure to (or effect of) a medical product or an environmental agent. 1
Example: CEA in colorectal cancer

Prognostic Biomarker

A biomarker used to identify likelihood of a clinical event, disease recurrence or progression in patients who have the disease or medical condition of interest.1
Example: Oncotype Dx®

Predictive Biomarker

A biomarker used to identify individuals who are more likely than similar individuals without the biomarker to experience a favorable or unfavorable effect from exposure to a medical product or an environmental agent.1
Example: Somatic BRCA PV eligible for treatment with PARP inhibitor

Pharmacodynamic/Response Biomarker

A biomarker used to show that a biological response has occurred in an individual who has been exposed to a medical product or an environmental agent.1
Example: 18F-FES, labeled nucleotide that correlates with ER expression17

Safety Biomarker

A biomarker measured before or after an exposure to a medical product or an environmental agent to indicate the likelihood, presence, or extent of toxicity as an adverse effect.1
Example: UGT1A1 genotyping for allele versions that increase risk of irinotecan-induced toxicities