xTAG® CYP2C19 Kit v3

Reliable genotyping assay for actionable results

The xTAG® CYP2C19 Kit v3 is an in vitro diagnostic test used as an aid to clinicians in determining therapeutic strategy for the therapeutics that are metabolized by the CYP2C19 gene product.

Cytochrome P450 2C19 (CYP2C19): Clinical Relevance

The CYP2C19 gene encodes a member of the cytochrome P450 superfamily of enzymes known to contribute to the metabolism of many clinically relevant drugs in several therapeutic areas. (Table 1).

Table 1: Examples of drugs metabolized by CYP2C19+,✗,1
CYP2C19 FDA Approved Drugs

Genetic Variation in CYP2C19

Like many other CYP450 superfamily members, the CYP2C19 gene is highly polymorphic (Table 2). An individual’s specific alleles can result in distinct drug metabolizing phenotypes for the various drugs and consequently the potential for different drug responses.

Genotypes CYP2C19*2 and CYP2C19*3 together account for approximately 99% and 87% of Asian and Caucasian poor metabolizers respectively.2

At least one loss-of-function allele is carried by 24% of the white non-Hispanic population, 18% of Mexicans, 33% of African Americans, and 50% of Asians. Homozygous carriers, who are poor CYP2C19 metabolizers, make up 3% to 4% of the population.3

Table 2: Frequency of 2C19 genotypes in various ethnicities4,6,7
CYP2C19 Genotype Frequency

Identification of patient CYP2C19 genotypes can help clinicians individualize drug treatment by selection of appropriate therapies. These measures may improve patient outcome by ensuring maximum drug efficacy with minimal adverse drug reactions (ADR).5  

References

  1. http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/ucm083378.htm
  2. xTAG CYP2C19 Kit v3, Package Insert, 2013
  3. Cleve Clin J Med. 2011 April ; 78(4): 243–257
  4. Clin Pharmacol Ther. 2011 August; 90(2): 328–332
  5. Becquemont L (June 2009). Pharmacogenomics 10 (6): 961–9
  6. R. J. Ferguson, et al. (1988) J Pharmacol Exp Ther, 284, 356-61.
  7. R. S. Pedersen, et al, (2012 )Eur J Clin Pharmacol, 68 , 1463-4.

 

Products for diagnostic use are region specific and may not be approved in some countries/regions. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.

The xTAG CYP2C19 Kit v3 is not indicated to be used with any specific drugs/medications

+ Intended Use for xTAG CYP2C19 Kit v3 (US-IVD): The xTAG CYP2C19 Kit v3 is an in vitro diagnostic test used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP450 2C19 gene, located on chromosome 10q24, from genomic DNA extracted from EDTA or citrate anti-coagulated whole blood samples. The xTAG CYP2C19 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for the therapeutics that are metabolized by the CYP2C19 gene product, specifically *2, *3 and *17. The kit is not indicated for stand-alone diagnostic purposes. This test is not intended to be used to predict drug response or non-response.

The xTAG CYP2C19 Kit v3 is indicated for use with the Luminex 100/200 instrument or MAGPIX with xPONENT software systems.

+ Intended Use for xTAG CYP2C19 Kit v3 (EU-IVD): The xTAG® CYP2C19 Kit v3 is an in vitro diagnostic test used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP450 2C19 gene, located on chromosome 10q24, from genomic DNA extracted from EDTA or citrate anticoagulated whole blood samples. The xTAG® CYP2C19 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for the therapeutics that are metabolized by the CYP2C19 gene product, specifically *1, *2, *3, *4, *5, *6, *7, *8, *9, *10 and *17.

xTAG CYP2C19 Kit v3 is not indicated for stand-alone diagnostic purposes. The information provided from this test may supplement decision making and should only be used in conjunction with routine monitoring by a physician. Because of the variability in the knowledge of clinical utility with specific drugs that are metabolized by CYP2C19, clinicians should use professional judgment in the interpretation of results from this test. Results from this type of assay should not be used in predicting a patient's response to drugs for which the drug metabolizing enzyme activity of that allele, or the drug metabolic pathway, has not been clearly established.

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Empowering Personalized Medicine

The xTAG® CYP2C19 assay is a genotyping panel covering clinically relevant mutations that helps identify up to 99% and 87% of poor metabolizers in Asians and Caucasians respectively.

  • Reliable Genotyping Assay - Detect and identify clinically relevant genotypes

  • Resource Efficient - Obtain flexibility in throughput with Luminex® 100/200 platform and/or MAGPIX instrument

  • Actionable Results - Gain confidence in results with high accuracy & reproducibility

Features of the xTAG CYP2C19 Kit v3
CYP2C19 Information

For more information on the xTAG CYP2C19 Kit v3, contact your Luminex Representative.

Alleles and SNPs detected by the xTAG CYP2C19 Kit v31,2

CYP2C19 Alleles and SNPs

References

  1. xTAG CYP2C19 Kit v3, Package Insert, 2013(EU-IVD)
  2. xTAG CYP2C19 Kit v3, Package Insert, 2013(US-IVD)

 

Products for diagnostic use are region specific and may not be approved in some countries/regions. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.

Intended Use for xTAG CYP2C19 Kit v3 (US-IVD): The xTAG CYP2C19 Kit v3 is an in vitro diagnostic test used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP450 2C19 gene, located on chromosome 10q24, from genomic DNA extracted from EDTA or citrate anti-coagulated whole blood samples. The xTAG CYP2C19 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for the therapeutics that are metabolized by the CYP2C19 gene product, specifically *2, *3 and *17. The kit is not indicated for stand-alone diagnostic purposes. This test is not intended to be used to predict drug response or non-response.

The xTAG CYP2C19 Kit v3 is indicated for use with the Luminex 100/200 instrument or MAGPIX with xPONENT software systems.

Intended Use for xTAG CYP2C19 Kit v3 (EU-IVD): The xTAG® CYP2C19 Kit v3 is an in vitro diagnostic test used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP450 2C19 gene, located on chromosome 10q24, from genomic DNA extracted from EDTA or citrate anticoagulated whole blood samples. The xTAG® CYP2C19 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for the therapeutics that are metabolized by the CYP2C19 gene product, specifically *1, *2, *3, *4, *5, *6, *7, *8, *9, *10 and *17.

xTAG CYP2C19 Kit v3 is not indicated for stand-alone diagnostic purposes. The information provided from this test may supplement decision making and should only be used in conjunction with routine monitoring by a physician. Because of the variability in the knowledge of clinical utility with specific drugs that are metabolized by CYP2C19, clinicians should use professional judgment in the interpretation of results from this test. Results from this type of assay should not be used in predicting a patient's response to drugs for which the drug metabolizing enzyme activity of that allele, or the drug metabolic pathway, has not been clearly established.

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Optimized protocol allowing flexible throughput on the Luminex® 100/200 platform & MAGPIX® instrument

  • Utilize scalability of the Luminex® instruments to increase throughput effectively
  • Ease of use with an all-inclusive kit with all ancillary reagents and enzyme necessary to run the assay
  • Expand testing on the existing Luminex® 100/200 platform to increase your lab menu

2d6-worflow.jpg

 

Products for diagnostic use are region specific and may not be approved in some countries/regions. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.

Intended Use for xTAG CYP2C19 Kit v3 (US-IVD): The xTAG CYP2C19 Kit v3 is an in vitro diagnostic test used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP450 2C19 gene, located on chromosome 10q24, from genomic DNA extracted from EDTA or citrate anti-coagulated whole blood samples. The xTAG CYP2C19 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for the therapeutics that are metabolized by the CYP2C19 gene product, specifically *2, *3 and *17. The kit is not indicated for stand-alone diagnostic purposes. This test is not intended to be used to predict drug response or non-response.

The xTAG CYP2C19 Kit v3 is indicated for use with the Luminex 100/200 instrument or MAGPIX with xPONENT software systems.

Intended Use for xTAG CYP2C19 Kit v3 (EU-IVD): The xTAG® CYP2C19 Kit v3 is an in vitro diagnostic test used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP450 2C19 gene, located on chromosome 10q24, from genomic DNA extracted from EDTA or citrate anticoagulated whole blood samples. The xTAG® CYP2C19 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for the therapeutics that are metabolized by the CYP2C19 gene product, specifically *1, *2, *3, *4, *5, *6, *7, *8, *9, *10 and *17.

xTAG CYP2C19 Kit v3 is not indicated for stand-alone diagnostic purposes. The information provided from this test may supplement decision making and should only be used in conjunction with routine monitoring by a physician. Because of the variability in the knowledge of clinical utility with specific drugs that are metabolized by CYP2C19, clinicians should use professional judgment in the interpretation of results from this test. Results from this type of assay should not be used in predicting a patient's response to drugs for which the drug metabolizing enzyme activity of that allele, or the drug metabolic pathway, has not been clearly established.

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Resources

Document Language Type Download
MSDS
     
MSDS (click to search database)      
Brochures      
Pharmacogenetics – Frequently Asked Questions English pdf pdfImg download

CYP2C19 Product Sheet (EU-IVD)

English    

CYP2C19 Product Sheet (US-IVD)

English    
White Papers      
Personalized Medicine through Pharmacogenetics English    
CYP2D6 Testing: An Opportunity to Improve Patient Care English    
CYP2C19: An Opportunity to Improve Patient Care English    
External Resources      
CPIC Guideline - Codeine Therapy in the Context of Cytochrome P450 2D6 (CPY2D6) English pdf pdfImg download
CPIC Guideline - CYP2D6 and CYP2C19 Genotypes and Dosing of Tricyclic Antidepressants English pdf pdfImg download
Table of Pharmacogenomic Biomarkers in Drug Labels English    
CPIC Guidelines for CYP2C19 Genotype and Clopidogrel Therapy English    

 

Products for diagnostic use are region specific and may not be approved in some countries/regions. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.

Intended Use for xTAG CYP2C19 Kit v3 (US-IVD): The xTAG CYP2C19 Kit v3 is an in vitro diagnostic test used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP450 2C19 gene, located on chromosome 10q24, from genomic DNA extracted from EDTA or citrate anti-coagulated whole blood samples. The xTAG CYP2C19 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for the therapeutics that are metabolized by the CYP2C19 gene product, specifically *2, *3 and *17. The kit is not indicated for stand-alone diagnostic purposes. This test is not intended to be used to predict drug response or non-response.

The xTAG CYP2C19 Kit v3 is indicated for use with the Luminex 100/200 instrument or MAGPIX with xPONENT software systems.

Intended Use for xTAG CYP2C19 Kit v3 (EU-IVD): The xTAG® CYP2C19 Kit v3 is an in vitro diagnostic test used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP450 2C19 gene, located on chromosome 10q24, from genomic DNA extracted from EDTA or citrate anticoagulated whole blood samples. The xTAG® CYP2C19 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for the therapeutics that are metabolized by the CYP2C19 gene product, specifically *1, *2, *3, *4, *5, *6, *7, *8, *9, *10 and *17.

xTAG CYP2C19 Kit v3 is not indicated for stand-alone diagnostic purposes. The information provided from this test may supplement decision making and should only be used in conjunction with routine monitoring by a physician. Because of the variability in the knowledge of clinical utility with specific drugs that are metabolized by CYP2C19, clinicians should use professional judgment in the interpretation of results from this test. Results from this type of assay should not be used in predicting a patient's response to drugs for which the drug metabolizing enzyme activity of that allele, or the drug metabolic pathway, has not been clearly established.

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Support Information

Luminex offers comprehensive technical support enabling companies and laboratories to perform clinical diagnosis quickly, accurately, and cost effectively while optimizing the customer experience with Luminex assays and systems.

Support Resources   Technical Support   Field Service
General Resources   Online Support Login   Certified Service Providers

  Email: [email protected]   Maintenance and Support

  Phone: 512-381-4397   Luminex Central Repair Facility

  Toll Free: 1-877-785-2323  
    International: + 800-2939-4959    

 

Products for diagnostic use are region specific and may not be approved in some countries/regions. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.

Intended Use for xTAG CYP2C19 Kit v3 (US-IVD): The xTAG CYP2C19 Kit v3 is an in vitro diagnostic test used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP450 2C19 gene, located on chromosome 10q24, from genomic DNA extracted from EDTA or citrate anti-coagulated whole blood samples. The xTAG CYP2C19 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for the therapeutics that are metabolized by the CYP2C19 gene product, specifically *2, *3 and *17. The kit is not indicated for stand-alone diagnostic purposes. This test is not intended to be used to predict drug response or non-response.

The xTAG CYP2C19 Kit v3 is indicated for use with the Luminex 100/200 instrument or MAGPIX with xPONENT software systems.

Intended Use for xTAG CYP2C19 Kit v3 (EU-IVD): The xTAG® CYP2C19 Kit v3 is an in vitro diagnostic test used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP450 2C19 gene, located on chromosome 10q24, from genomic DNA extracted from EDTA or citrate anticoagulated whole blood samples. The xTAG® CYP2C19 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for the therapeutics that are metabolized by the CYP2C19 gene product, specifically *1, *2, *3, *4, *5, *6, *7, *8, *9, *10 and *17.

xTAG CYP2C19 Kit v3 is not indicated for stand-alone diagnostic purposes. The information provided from this test may supplement decision making and should only be used in conjunction with routine monitoring by a physician. Because of the variability in the knowledge of clinical utility with specific drugs that are metabolized by CYP2C19, clinicians should use professional judgment in the interpretation of results from this test. Results from this type of assay should not be used in predicting a patient's response to drugs for which the drug metabolizing enzyme activity of that allele, or the drug metabolic pathway, has not been clearly established.

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Ordering Information

Luminex Direct
Luminex Online Order Management
Email: [email protected]
Phone: 1-512-336-3550
Toll Free: 1-866-401-5450
Fax: 1-512-219-0544
Fax: +31(0)73 800 1998 (EMEA, India)

 

ORDERING

Product Name Kit Size Registration Status Catalog Number Available from
xTAG® CYP2C19 Kit v3 48 Tests US IVD I046B0427 Luminex
TDAS CYP2C19 Kit v3 Analysis Software CD   US IVD S046-0275 Luminex
xTAG® CYP2C19 Kit v3 48 Tests EU IVD I046B0428 Luminex
TDAS CYP2C19 Kit v3 Analysis Software CD   EU IVD S046-0276 Luminex
xTAG® CYP2C19 Kit v3 48 Tests CA-IVD I046B0432 Luminex
TDAS CYP2C19 Kit v3 Analysis Software CD   CA-IVD S046-0278 Luminex

 

Products for diagnostic use are region specific and may not be approved in some countries/regions. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.

Intended Use for xTAG CYP2C19 Kit v3 (US-IVD): The xTAG CYP2C19 Kit v3 is an in vitro diagnostic test used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP450 2C19 gene, located on chromosome 10q24, from genomic DNA extracted from EDTA or citrate anti-coagulated whole blood samples. The xTAG CYP2C19 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for the therapeutics that are metabolized by the CYP2C19 gene product, specifically *2, *3 and *17. The kit is not indicated for stand-alone diagnostic purposes. This test is not intended to be used to predict drug response or non-response.

The xTAG CYP2C19 Kit v3 is indicated for use with the Luminex 100/200 instrument or MAGPIX with xPONENT software systems.

Intended Use for xTAG CYP2C19 Kit v3 (EU-IVD): The xTAG® CYP2C19 Kit v3 is an in vitro diagnostic test used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP450 2C19 gene, located on chromosome 10q24, from genomic DNA extracted from EDTA or citrate anticoagulated whole blood samples. The xTAG® CYP2C19 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for the therapeutics that are metabolized by the CYP2C19 gene product, specifically *1, *2, *3, *4, *5, *6, *7, *8, *9, *10 and *17.

xTAG CYP2C19 Kit v3 is not indicated for stand-alone diagnostic purposes. The information provided from this test may supplement decision making and should only be used in conjunction with routine monitoring by a physician. Because of the variability in the knowledge of clinical utility with specific drugs that are metabolized by CYP2C19, clinicians should use professional judgment in the interpretation of results from this test. Results from this type of assay should not be used in predicting a patient's response to drugs for which the drug metabolizing enzyme activity of that allele, or the drug metabolic pathway, has not been clearly established.

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