CYP2C19 Genotyping Kit


·Simultaneously detect 3 SNP loci (CYP2C19*2, *3, *17)

·Assist doctors in selecting the appropriate drug doses or changing to other drugs to avoid drug resistance or severe adverse effects

·Guide the clinical use of more than 10 drugs including Clopidogrel, Omeprazole, ect

·Test once, benefit lifetime

Cytochrome P450 2C19 (CYP2C19)

Genes are carriers of genetic information of all organisms and are operators and regulators of life. Individual differences in drug response and efficacy are mainly determined by single nucleotide polymorphisms (SNPs) of genes. Therefore, genotyping of SNPs is crucial for providing individualized medication guide.

CYP2C19 gene is responsible for encoding the CYP2C19 (s-mephenytoin hydroxylase), which is one of the most important cytochrome P450 enzymes. CYP2C19 metabolizes many clinically important drugs including antiplatelet drug clopidogrel, proton pump inhibitors, antidepressants, antifungals, progestogen, etc [1-2]. The gene SNPs will affect the enzyme activity, and therefore influence the drug response.

Classes of drugs metabolized by CYP2C19 [1-2]

Genetic Variations of CYP2C19

Genetic variations of the CYP2C19 gene among patients are major causes of variability in drug response to medications. CYP2C19*1 allele is considered the wild-type, or “normal” allele, with “normal” enzyme activity. CYP2C19*2, *3 and *17 will result in different levels of enzyme activity compared to the wild-type, therefore affect the drug response. For example, CYP2C19*2, a loss-of-function allele, is associated with increased risk for serious adverse cardiovascular events in both heterozygous and homozygous patients (~25–50% of the population) with acute coronary syndromes (ACSs) who are receiving clopidogrel, particularly among those undergoing percutaneous coronary intervention (PCI) [4].

Major CYP2C19 Alleles, Enzyme Activity, and Frequency in Population[2-3]

CYP2C19 Metabolizer Phenotypes

The CYP2C19 genotype of a patient affects the level of enzyme activity (“phenotype”). CYP2C19 phenotype can be classified into four groups.

Drug metabolism capacities are determined by the CYP2C19 genotypes, therefore CYP2C19 genotyping will provide the personalized medicine guide.

Frequencies of CYP2C19 metabolism capacities in Asian population[4]

Product introduction

Applying Advanced Fragment Analysis (AFA) technology, the kit provides fast, accurate and effective CYP2C19 genotyping. It simultaneously amplifies 3 SNP loci (*2, *3, *17) of CYP2C19 gene in one tube, and separates the different size of fragments by capillary electrophoresis.


· High accuracy: 100% consistency with Sanger sequencing results (>2100 samples)

· Sample compatibility: suitable for either blood or buccal swab

· Time saving: from sample to answer within 4 hours,and hands-on time nearly 0.5 hours

· User friendly: 8-tube strip format, add enzyme and sample to start;automated report

· Monitor every single reaction: build in internal reaction control for monitoring PCR process

· Free of carry-over contamination: build in dUTP-UNG system


Example electropherogram of CYP2C19 genotyping

Order Information

SureX® CYP2C19 Genotyping Kit (CE-IVD)24 tests/kit1060074ABI 3130/3130xl/3500 Dx/3500xL Dx


[1] Lee SJ. Clinical application of CYP2C19 pharmacogenetics toward more personalized medicine. Front Genet. 2013 Feb 1; 3:318.

[2] Samer CF, et al. Applications of CYP450 testing in the clinical setting. Mol Diagn Ther 2013; 17(3):165-184.

[3] Scott SA, et al. PharmGKB summary: Very important pharmacogene information for cytochrome P450, family 2, subfamily C, polypeptide 19.Pharmacogenet Genomics 2012;22(2):159-65.

[4] SA Scott, K Sangkuhl, EE Gardner, et al. Clinical Pharmacogenetics Implementation Consortium Guidelines for Cytochrome P450-2C19 (CYP2C19) Genotype and Clopidogrel Therapy. Clin Pharmacol Ther. 2011 Aug; 90(2):328-32.

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