Pathological Digital Biomarkers: Validation and Application

Abstract

Digital pathology offers powerful tools for biomarker discovery, analysis, and translation. Despite its advantages, the clinical adoption of digital pathology has been slow. A clinical and methodological validation is required for novel digital pathological biomarkers. Four steps are required to validate a novel pathological digital biomarker for clinical use: sample collection and processing, analytical validation, clinical validation, and clinical utility. The digital biomarkers and their diagnostic, monitoring, pharmacodynamic response, predictive, prognostic, safety, and risk assessment applications are discussed. Adopting pathological digital biomarkers can be used in conjunction with other diagnostic technologies to select the most appropriate patient treatment, thereby reducing patient suffering and healthcare costs.

Keywords

• digital pathology
• biomarker
• validation
• application
• regulation