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Preanalytic and Analytic Quality System Considerations in Noncoding RNA Biomarker Development for Clinical
William S Schleif1,2, Sara M Sarasua1, Jane M DeLuca1
1Healthcare Genetics Program, School of Nursing, College of Health, Education, and Human Development, Clemson University, Clemson, South Carolina, USA.
Genetic Testing and Molecular Biomarkers
|May 31, 2023
Summary
Non-coding (nc) RNAs show promise as biomarkers, but standardization issues hinder clinical use. Addressing preanalytical and analytical variations is crucial for reliable ncRNA biomarker development and diagnostic applications.
Area of Science:
- Biomedical research
- Molecular diagnostics
- Biomarker discovery
Background:
- Non-coding RNAs (ncRNAs) are frequently investigated as potential quantitative biomarkers for various health conditions.
- Despite strong preclinical evidence, ncRNA analyses face challenges in widespread diagnostic adoption due to reproducibility issues.
- Preanalytical and analytical variations in sample handling and differences between small and long ncRNAs contribute to translation obstacles.
Purpose of the Study:
- To review critical gaps in non-coding RNA (ncRNA) biomarker validation studies.
- To examine ncRNA biomarker development through the lens of Clinical Laboratory Improvement Amendments (CLIA) regulations for laboratory-developed tests (LDTs).
- To identify key pre-analytical variables impacting ncRNA testing performance.
Main Methods:
- A narrative literature review was conducted.
- The review focused on selected literature concerning ncRNA biomarker validation.
- Analysis was performed considering US CLIA regulations for laboratory-developed tests (LDTs).
Main Results:
- Leading candidate ncRNA subclasses, their biogenesis, and cellular functions were described.
- Specific pre-analytical variables with significant impact on testing performance were identified.
- Critical gaps in current ncRNA validation studies were highlighted.
Conclusions:
- Standardization of preanalytical and analytical processes is essential for reliable ncRNA biomarker development.
- Addressing identified gaps and variables will facilitate the translation of ncRNA biomarkers into clinical diagnostics.
- Recommendations are provided for scientists and clinicians involved in ncRNA biomarker research and development.
