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SCIENTIFIC TECHNOLOGY LIBRARY / 06

Biomarkers & Translational Medicine

Connecting molecular measurements to meaningful clinical questions.

Editorial review: November 2026
Abstract medical biomarker science image06 / 06
01

Overview

Biomarkers are measurable indicators of biological processes or responses to interventions. Their value depends on the intended purpose and population.

02

Biological mechanism

Proteins, nucleic acids, metabolites, imaging data and digital signals can serve as candidate biomarkers.

03

Preclinical evidence

Candidates are explored in experimental settings; analytical validity and biological variability require further evaluation.

04

Human studies

Human studies distinguish analytical validity, clinical validity and context of use. FDA's qualification program evaluates biomarkers for specific drug-development uses.

05

Limitations & safety

Collection conditions, assay harmonization, sensitivity and specificity, population differences and overinterpretation are major limitations.

This page is for scientific education, not personal medical advice, an approved-treatment claim or a product recommendation. Each source must be read within its own scope.