biomarker
Measurable biological indicator used to assess cancer diagnosis, prognosis, or treatment response in clinical informatics.
Full Definition
A biomarker is a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention. In oncology, biomarkers include molecular signatures, genetic mutations, protein levels, or imaging characteristics that provide information about cancer diagnosis, prognosis, or likelihood of treatment response. Biomarker data must be standardized, validated, and integrated into clinical information systems to support precision medicine approaches. The FDA has established specific guidelines for biomarker qualification and regulatory acceptance in drug development.
Usage
Usage note: Use 'biomarker' as one word, not 'bio-marker' or 'bio marker'. Distinguish between predictive, prognostic, and diagnostic biomarkers when specificity is required.
In Context
- "HER2 status serves as a predictive biomarker for trastuzumab therapy effectiveness." — Treatment protocol
- "The laboratory information system was updated to capture genomic biomarker results." — System upgrade documentation