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Quality control materials for pharmacogenomic testing in the clinic
Guigao Lin1, Kuo Zhang1, Yanxi Han1
1.
Clinical Chemistry and Laboratory Medicine
|November 16, 2016
Summary
Quality control materials are crucial for pharmacogenomic testing, but often difficult to obtain. This review discusses QC material sources and highlights novel methods for renewable controls, emphasizing the need for better controls in next-generation sequencing assays.
Area of Science:
- Pharmacogenomics and clinical pharmacology
- Genetic testing and diagnostics
Background:
- Pharmacogenomics has transformed treatment decisions by improving understanding of drug responses.
- Clinical adoption of genetic variation analysis for therapeutic purposes necessitates robust quality control (QC).
- Acquiring well-characterized QC materials for pharmacogenomic tests is a significant challenge.
Purpose of the Study:
- To review available sources of appropriate QC materials for therapy-associated genetic testing.
- To highlight novel methods for producing renewable QC materials that mimic patient samples.
- To identify areas needing further development for QC in next-generation sequencing (NGS) assays.
Main Methods:
- Literature review of QC material sources for pharmacogenomic testing.
- Discussion of novel production methods for renewable QC materials.
- Analysis of challenges in developing QC for NGS-based pharmacogenomic assays.
Main Results:
- Several sources of QC materials for genetic testing are available.
- Novel methods offer potential for renewable controls resembling patient samples.
- Technological complexity hinders the development of adequate QC for NGS assays.
Conclusions:
- Effective QC materials are essential for reliable pharmacogenomic testing in clinical settings.
- Renewable QC materials present a promising solution to acquisition challenges.
- Further research and development are required to create suitable QC solutions for NGS-based pharmacogenomic tests.
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