Biomarakerien
Biomarakerien are measurable indicators of biological processes, disease states, or responses to treatment. They include molecules such as DNA variants, RNA transcripts, proteins, metabolites, or imaging features.
They can be diagnostic (indicating disease presence), prognostic (forecasting disease course), predictive (forecasting treatment response), pharmacodynamic
Applications include clinical diagnosis and monitoring, drug development, precision medicine, and risk stratification in research and
Measurement spans genomics, proteomics, metabolomics, epigenetics, and imaging, with examples such as cell-free DNA and circulating
Validation requires analytical validity, clinical validity, and clinical utility. Regulatory bodies such as the FDA and
Examples include PSA for prostate cancer risk, HbA1c for diabetes control, troponin for myocardial injury, and
Limitations include biological variability, pre-analytical factors, assay differences, and cost; ethical and privacy considerations also apply
Emerging trends combine multi-omics and digital biomarkers from wearables, supported by data science to identify robust