xTAG® CYP2D6 Kit v3

Comprehensive genotyping assay for reliable, actionable results
The xTAG® CYP2D6 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for therapeutics metabolized by the CYP2D6 gene product.

Cytochrome P450 2D6 (CYP2D6): Clinical Relevance

The CYP2D6 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. Cardiovascular drugs, anti-depressants and analgesics are the top three classes of therapeutics prescribed.1 Many of these medications are metabolized by the CYP2D6 enzyme (Table 1).

Table 1: Examples of drugs metabolized by CYP2D62
CYP2D6 Examples of Metabolized Drugs

Genetic Variation in CYP2D6

The CYP2D6 gene is highly polymorphic across the human population. An individual's specific allele combination can result in distinct drug metabolizing phenotypes and consequently the potential for different drug responses. Identification of patient CYP2D6 genotypes can help clinicians individualize drug treatment by selecting appropriate therapies. These measures may improve patient outcome by ensuring maximum drug efficacy with minimal ADRs.3

A number of specific polymorphisms have been found in the CYP2D6 gene that results in enzymatic deficiencies. The frequency of these polymorphisms varies within the major ethnic groups. CYP2D6 polymorphisms that produce poor metabolizers are found with frequencies of 7% to 10% in Caucasians, 2% in Africans and African Americans, and 1% in Asians.4

Identification of patient CYP2D6 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.imshealth.com/
  2. http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/ucm083378.htm
  3. Becquemont L (June 2009). Pharmacogenomics 10 (6): 961–9.
  4. http://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/83180
  5. xTAG® CYP2D6 Kit v3 (2013). Package Insert

 

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: The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from EDTA and citrate anticoagulated whole blood samples. This kit can also identify gene rearrangements associated with the deletion (*5) and duplication genotypes. The xTAG CYP2D6 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for therapeutics that are metabolized by the CYP2D6 gene product. This kit is not indicated for stand-alone diagnostic purposes. This test is not intended to be used to predict drug response or non-response.

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The xTAG® CYP2D6 Kit v3 detects a panel of nucleotide variants including gene rearrangements associated with the deletion (*5) and duplication genotypes.

The assay incorporates multiplex Polymerase Chain Reaction (PCR) and multiplex Allele Specific Primer Extension (ASPE) with Luminex's Universal Tag sorting system on the Luminex® 100/200™ xMAP® platform. 

Reliable - High quality in vitro diagnostic test with 100% accuracy and reproducibility++,1
Actionable - Detect 17 different mutations/polymorphisms, in addition to gene deletion and duplication
Efficient - Automated genotyping and streamlined protocol provides same day results
Flexible - Complete assay kit with flexible throughput for the Luminex® 100/200™ platform

 

Features of the xTAG CYP2D6 Kit v31
CYP2D6 Features

 

Alleles and SNPs detected by the xTAG CYP2D6 Kit v31

  • Comprehensive allele coverage, including gene deletion and duplication genotypes
  • Genotyping panel detects major alleles associated with variant drug metabolism

CYP2D6 Alleles and SNPs

 

References

  1. xTAG® CYP2D6 Kit v3 Package Insert
  2. Bradford, L. D. (2002). “CYP2D6 allele frequency in European Caucasians, Asians, Africans and their descendants.” Pharmacogenomics 3(2): 229-43
  3. Wennerholm, A., I. Johansson, et al. (2001). “Characterization of the CYP2D6*29 allele commonly present in a black Tanzanian population causing reduced catalytic activity.” Pharmacogenetics 11(5): 417-427
  4. Gaedigk, A., D. L. Ryder, et al. (2003). “CYP2D6 poor metabolizer status can be ruled out by a single genotyping assay for the -1584G promoter polymorphism.” Clin Chem 49(6 Pt 1): 1008-11.

 

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: The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from EDTA and citrate anticoagulated whole blood samples. This kit can also identify gene rearrangements associated with the deletion (*5) and duplication genotypes. The xTAG CYP2D6 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for therapeutics that are metabolized by the CYP2D6 gene product. This kit is not indicated for stand-alone diagnostic purposes. This test is not intended to be used to predict drug response or non-response.

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Optimized workflow on the proven Luminex® 100/200 platform

  • Utilize scalability of the Luminex® 100/200™ platform to increase throughput effectively
  • Ease of use with an all-inclusive kit containing all ancillary reagents and enzyme necessary to run the assay
  • Improve resource efficiency with an optimized workflow

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: The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from EDTA and citrate anticoagulated whole blood samples. This kit can also identify gene rearrangements associated with the deletion (*5) and duplication genotypes. The xTAG CYP2D6 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for therapeutics that are metabolized by the CYP2D6 gene product. This kit is not indicated for stand-alone diagnostic purposes. This test is not intended to be used to predict drug response or non-response.

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Resources

Document Language Type Download
MSDS
     
MSDS (click to search database)      
Brochure      
Empowering Personalized Medicine
- xTAG® CYP2D6 Kit v3 Brochure (US)
English pdf pdfImg download
Empowering Personalized Medicine
- xTAG® CYP2D6 Kit v3 Brochure (Europe)
English pdf pdfImg download
CYP2D6 Product Sheet English pdf pdfImg download
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    

 

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: The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from EDTA and citrate anticoagulated whole blood samples. This kit can also identify gene rearrangements associated with the deletion (*5) and duplication genotypes. The xTAG CYP2D6 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for therapeutics that are metabolized by the CYP2D6 gene product. This kit is not indicated for stand-alone diagnostic purposes. This test is not intended to be used to predict drug response or non-response.

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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: The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from EDTA and citrate anticoagulated whole blood samples. This kit can also identify gene rearrangements associated with the deletion (*5) and duplication genotypes. The xTAG CYP2D6 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for therapeutics that are metabolized by the CYP2D6 gene product. This kit is not indicated for stand-alone diagnostic purposes. This test is not intended to be used to predict drug response or non-response.

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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: 31-162-408330 (EMEA, India)

 

ORDERING

Product Name Kit Size Registration Status Catalog Number Available from
xTAG® CYP2D6 Kit v3 (US IVD) 48 Tests IVD-US I030B0373 Luminex
xTAG® CYP2D6 Kit v3 Analysis Software CD   IVD-US S030-0254 Luminex
xTAG® CYP2D6 Kit v3 (EU IVD) 48 Tests EU IVD I030B0374 Luminex
xTAG® CYP2D6 Kit v3 Analysis Software CD (EU IVD)   EU IVD S030-0255 Luminex
xTAG® CYP2D6 Kit v3 (US IVD) 384 Tests IVD-US I030E0443 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: The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from EDTA and citrate anticoagulated whole blood samples. This kit can also identify gene rearrangements associated with the deletion (*5) and duplication genotypes. The xTAG CYP2D6 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for therapeutics that are metabolized by the CYP2D6 gene product. This kit is not indicated for stand-alone diagnostic purposes. This test is not intended to be used to predict drug response or non-response.

IVD logo