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.
| Original language | English |
|---|---|
| Article number | 9823 |
| Journal | Applied Sciences (Switzerland) |
| Volume | 12 |
| Issue number | 19 |
| DOIs | |
| State | Published - Oct 2022 |
Bibliographical note
Funding Information:This work was supported by the National Research Foundation of Korea (NRF) through a grant funded by the Korean government (MSIT) (grant number 2017R1E1A1A01078335 and 2022R1A2C1092956) and the Institute of Clinical Medicine Research in the Yeouido St. Mary’s Hospital.
Publisher Copyright:
© 2022 by the authors.
Keywords
- application
- biomarker
- digital pathology
- regulation
- validation