CYP2C19
For Investigational Use Only. Performance characteristics of this product have not been established.
| Verigene®CYP2C19 Test | |||
|---|---|---|---|
| Targets | CYP2C19 Allelic Variants | ||
| *1 wild type | |||
| *2A (19154G>A) | |||
| *3 (17948G>A) | |||
| Automation | Sample-to-Result | ||
| Instrumentation | Verigene Reader and Processor SP | ||
| Workflow | Random Access | ||
| Sample Type | Whole Blood | ||
| Pipetting Steps | 1 | ||
| Hands-On Time | <5 minutes | ||
| Run Time | 2.5 hours | ||
Background
CYP2C19 is a drug-metabolizing enzyme in the CYP450 family, which is encoded by the CYP2C19 gene. CYP2C19 metabolizes 15% of all prescribed drugs and is important in the metabolism of drugs including antiarrhythmics, proton pump inhibitors, antiplatelet drugs, and antidepressants. Common polymorphisms in the CYP2C19 gene, seen in approximately 30% of Caucasians, 40% of Africans, and more than 55% of East Asians, significantly diminish both the pharmacokinetic and pharmaco-dynamic responses to drugs metabolized by CYP2C19.
The Verigene® CYP2C19 Test identifies a patient’s CYP2C19 *2 and *3 genotype directly from a whole blood sample in about 2.5 hours. With the sample-to-result Verigene System, users can process tests on-demand, without the need for batch processing, specially trained personnel, or specialized facilities, enabling rapid patient results 24/7.
Workflow
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STEP 1
Load Test Cartridge, test consumables, and sample into Processor SP
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STEP 2
Automated sample preparation and test processing on Processor SP
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STEP 3
Place slide from Test Cartridge in Verigene Reader for results
Literature Cited
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"Evaluation of a Microarray-Based Genotyping Assay for the Rapid Detection of Cytochrome P450 2C19 *2 and *3 Polymorphisms From Whole Blood Using Nanoparticle Probes"American Journal of Clinical Pathology01 October 2011Full data136(4):604-8Abstract
Numerous drugs such as clopidogrel have been developed to reduce coagulation or inhibit platelet function. The hepatic cytochrome P450 (CYP) pathway is involved in the conversion of clopidogrel to its active metabolite. A recent black-box warning was included in the clopidogrel package insert indicating a significant clinical link between specific CYP2C19 genetic variants and poor metabolism of clopidogrel. Of these variants, (*)2 and (*)3 are the most common and are associated with complete loss of enzyme activity. In patients who are carriers of a CYP2C19 (*)2 or (*)3 allele, the conversion of clopidogrel to its active metabolite may be reduced, which can lead to ischemic events and negative consequence for the patient. We examined the ability of the Verigene CLO assay (Nanosphere, Northbrook, IL) to identify CYP2C19 (*)2 and (*)3 polymorphisms in 1,286 unique whole blood samples. The Verigene CLO assay accurately identified homozygous and heterozygous (*)2 and (*)3 phenotypes with a specificity of 100% and a final call rate of 99.7%. The assay is fully automated and can produce a result in approximately 3.5 hours.
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"Pharmacogenetics of Clopidogrel: Comparison Between a Standard and a Rapid Genetic Testing"Genet Test Mol Biomarkers12 January 2012Full dataAbstract
Aims: CYP2C19 variant alleles are independent predictors of clopidogrel response variability and occurrence of major adverse cardiovascular events in high-risk vascular patients on clopidogrel therapy. Increasing evidence suggests a combination of platelet function testing with CYP2C19 genetic testing may be more effective in identifying high-risk individuals for alternative antiplatelet therapeutic strategies. A crucial point in evaluating the use of these polymorphisms in the clinical practice, besides test accuracy, is the cost of the genetic test and rapid availability of the results. One hundred acute coronary syndrome patients were genotyped for CYP2C19*2,*3,*4,*5, and *17 polymorphisms with two platforms: Verigene® and the TaqMan® system. Results: Genotyping results obtained by the classical TaqMan approach and the rapid Verigene approach showed a 100% concordance for all the five polymorphisms investigated. The Verigene system had shorter turnaround time with respect to the TaqMan. The cost of reagents for TaqMan genotyping was lower than that for the Verigene system, but the effective manual staff involvement and the relative cost resulted in higher cost for TaqMan than for Verigene. Conclusions: The Verigene system demonstrated good performance in terms of turnaround time and cost for the evaluation of the clopidogrel poor metabolizer status, giving genetic information in suitable time (206 min) for a therapeutic strategy decision.