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Establishing national reference materials for genetic testing of cytochrome P450.

Zheng Jia¹, Junju Huang², Ying Yang³

¹Department of In Vitro Diagnostic Reagent, National Institutes for Food and Drug Control, Beijing.

Pharmacogenetics and Genomics

|April 19, 2024

Summary

A new national reference material (NRM) was established for cytochrome P450 (CYP) gene testing in the Chinese population. This NRM ensures the quality of in-vitro diagnostic reagents for accurate drug metabolism gene polymorphism detection.

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Area of Science:

Pharmacogenomics
Clinical Diagnostics
Molecular Biology

Background:

Reference materials are crucial for in-vitro diagnostic (IVD) reagent quality and clinical test accuracy.
Cytochrome P450 (CYP) genes are vital for drug metabolism, and their polymorphisms influence treatment efficacy and safety.
Establishing population-specific reference materials is essential for accurate pharmacogenetic testing.

Purpose of the Study:

To establish a National Reference Material (NRM) for detecting drug metabolism-related cytochrome P450 (CYP) gene polymorphisms.
To identify CYP gene polymorphism characteristics specific to the Chinese population through database screening.
To ensure the quality and accuracy of IVD reagents used for CYP genetic testing.

Main Methods:

DNA from healthy human immortalized B lymphoblastoid cell lines was used as the raw material for the NRM.
Cell line samples were sourced from the Chinese Population PGx Gene Polymorphism Biobank.
Sanger sequencing, next-generation sequencing, and commercial assay kits were employed for polymorphic genotype validation.

Main Results:

Twenty-four drug metabolism-related CYP superfamily gene loci were confirmed, with evidence levels of 1A, 2A, 3, and 4.
Polymorphic loci were identified and their genotypes validated using multiple sequencing techniques.
The established NRM demonstrated high precision and stability, consistent with biobank polymorphism data.

Conclusions:

A National Reference Material (NRM 360 056-202 201) for CYP genetic testing was successfully established and approved.
This NRM covers 24 drug metabolism-related CYP gene loci.
The NRM will be used to assess IVD reagents for CYP gene polymorphisms and for clinical inter-room quality evaluations.