Biomarkørermålbare

Biomarkørermålbare is a term used to describe features, outcomes, or endpoints that can be quantified or assessed using biomarkers. It refers to attributes that reflect biological processes, disease states, or pharmacologic responses in a way that can be measured with analytical assays, imaging, or physiological readouts. The concept is central to biomarker-driven research and precision medicine, where decisions are guided by measurable biological indicators rather than solely clinical signs.

To be considered biomarkørermålbare, the feature should be supported by analytical validity (reliability and accuracy of the measurement), clinical validity (clear association with the disease, progression, or treatment effect), and ideally clinical utility (demonstrated benefit in decision-making or patient outcomes). Standardization of assays, reproducibility across laboratories, and appropriate regulatory or guideline acceptance are important considerations. Biomarkers may serve diagnostic, prognostic, predictive, or pharmacodynamic roles, and may originate from molecular, imaging, or physiological domains. Context of use, pre-analytical conditions, and appropriate statistical validation are essential for establishing measurability.

Applications of biomarkørermålbare span drug development, clinical trials, and routine care. They can enable earlier decision-making, dose optimization, patient stratification, and disease monitoring. Examples include HbA1c as a biomarker for long-term glycemic control, troponin for myocardial injury, and PET-based measures of receptor occupancy. Limitations include biological variability, pre-analytical factors, and the risk of misinterpreting association as causation. Ongoing advances focus on multiplex panels, standardization, and integration with real-world data to enhance measurability and clinical impact.