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xTAG® CYP2D6 Kit v3

xTAG CYP2D6 Pharmacogenetics Testing

Simplify genotyping complexity with accurate detection, comprehensive allele coverage, and reliable results

Simplify the complexity of CYP2D6 genotyping with our FDA-cleared in vitro diagnostic test that detects important CYP2D6 nucleotide variants including gene deletion and gene duplication. Identify individuals with CYP2D6 polymorphisms across different populations. Obtain unambiguous calls for all samples automatically with xTAG® Data Analysis Software.

 

Cytochrome P450 2D6 is thought to be active in the breakdown of many drugs including, anti-psychotics, analgesics and cardiovascular drugs. The CYP2D6 gene is highly polymorphic across the human population. CYP2D6 polymorphisms that produce poor metabolizers are found with frequencies of 6% to 10% in Caucasians, 2% in Africans and African Americans, and 1% in Asians.1 Identification of patient CYP2D6 genotypes can help clinicians individualize drug treatment by selecting appropriate therapies.2

 

Comprehensive Genotyping Assay for Reliable, Accurate Results

 

xTAG® CYP2D6 Kit v3 is a qualitative genotyping assay, which can aid clinicians in determining therapeutic strategy for drugs metabolized by the CYP2D6 gene product. It 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. The test automatically determines the diplotype of each sample.

Reliable

High quality in vitro diagnostic test with 100% accuracy and reproducibility3

Actionable

Detect 17 different mutations/polymorphisms, including gene deletion and duplication

Efficient

Genotyping and streamlined protocol provides same day results

Features of xTAG CYP2D6 Kit v3:

 

  • Genotypes (IVD Panel) — *1, *2, *3, *4, *5, *6, *7, *8, *9, *10, *11, *15, *17, *29, *35, *41
  • Instrument & Software — Luminex 100/200 instrument with xPONENT® 3.1 software
  • Reproducibility† — 100%
  • Kit Accuracy — 100% compared to Dideoxy Sequencing†
  • Optimal Input DNA — 24 ng to 1800 ng
  • Sample Type — EDTA Blood & Citrate Blood
  •  

    †After allowable reruns

     

     

    Alleles and SNPs detected by xTAG CYP2D6 Kit v33

     

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

     

    xTAG CYP2D6 Kit v3 Alleles and SNPs
    *Genotype SNPs detected by xTAG CYP2D6 Kit v3 Frequency in the U.S. Caucasian population4 Frequency in the African American population4 Predicted Enzyme Activity
    *1 None 37 to 40% 29 to 35% Normal
    *2 -1584C>G, 1661G>C, 2850C>T, 4180G>C 26 to 33% 18 to 27% Normal
    *3 2549A>del 1% 0.2 to 0.6% None
    *4 100C>T, 1661G>C, 1846G>A, 4180G>C, 2850C>T 18 to 20% 6 to 9% None
    *5 deletion 2 to 4% 6 to 7% None
    *6 1707T>del, 4180G>C 1% 0.5% None
    *7 2935A>C Not known Not known None
    *8 1661G>C, 1758G>T, 2850C>T, 4180G>C Not known Not known None
    *9 2613delAGA 2 to 3% 0.3% Reduced
    *10 100C>T, 1661G>C, 4180G>C 2 to 8% 0.3 to 0.4% Reduced
    *11 883G>C, 1661G>C, 2850C>T, 4180G>C Not known Not known None
    *15 138insT Not known Not known None
    *17 1023C>T, 1661G>C, 2850C>T, 4180G>C 0.2 to 0.3% 15 to 26% Reduced
    *29 1659G>A, 1661G>C, 2850C>T, 3183G>A, 4180G>C Not known5 Not known5 Reduced
    *35 -1584C>G, 31G>A, 1661G>C, 2850C>T, 4180G>C 7.4%6 1%6 Normal
    *41 1661G>C, 2850C>T, 2988G>A, 4180G>C 9%6 11%6 Reduced
    DUP duplication

xTAG CYP2D6 Kit v3 Workflow

 

Optimized workflow on the proven Luminex 100/200 platform

 

  • Scalable: Flexible throughput with the Luminex system
  • Ease of use: All-inclusive kit containing necessary reagents and enzymes
  • Efficient: Multiple IVD assays on the same platform and optimized workflow for each assay saves time

 

CYP2D6 & CYP2C19 Workflow

Ordering Information

 

Luminex Online Order Management
Email: [email protected]
Phone: 1-512-336-3550
Toll Free: 1-866-219-5450
Fax: 1-512-219-0544
Fax (Europe, Middle East, Asia, India): +31 (0)73 800 1998
Product Name Kit Size Registration Status Part Number
xTAG CYP2D6 Kit v3 (US-IVD) 48 Tests US-IVD I030B0373
xTAG CYP2D6 Kit v3 (US-IVD) 384 Tests US-IVD I030E0443
xTAG CYP2D6 Kit v3 48 Tests CA-IVD I030B0451
xTAG CYP2D6 Kit v3 (EU-IVD) 48 Tests CE Marked in EU and
SFDA Approved
I030B0374
xTAG CYP2D6 Kit v3 Analysis Software CD (EU-IVD)*   CE Marked in EU and
SFDA Approved
S030-0255
*Only available with the purchase of a kit.

xTAG CYP2D6 Kit v3 Resources:

 

xTAG CYP2D6 Kit v3Product Sheet (US)


Pharmacogenomic Biomarkers in Drug LabelsU.S. Food & Drug Administration

  1. Tramadol Therapy and CYP2D6 Genotype. Medical Genetic Summaries (Internet). Cited 2017 October. Available from: https://www.ncbi.nlm.nih.gov/books/NBK315950/.
  2. Becquemont L (June 2009). Pharmacogenomics 10 (6): 961–9.
  3. xTAG CYP2D6 Kit v3 Package Insert
  4. Bradford LD. CYP2D6 allele frequency in European Caucasians, Asians, Africans and their descendants. Pharmacogenomics 2002; 3(2): 229-43.
  5. Wennerholm A, Johansson I, et al. Characterization of the CYP2D6*29 allele commonly present in a black Tanzanian population causing reduced catalytic activity. Pharmacogenetics 2001; 11(5):417-427.
  6. Gaedigk A, Ryder DL. CYP2D6 poor metabolizer status can be ruled out by a single genotyping assay for the -1584G promoter polymorphism. Clin Chem 2003;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 (US-IVD):

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.

Intended Use (CA-IVD):

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, specifically *1, *2, *3, *4, *5, *6, *7, *8, *9, *10, *11, *15, *17, *29, *35, *41, and DUP. xTAG CYP2D6 Kit v3 is not indicated for stand-alone diagnostic purposes. The information provided form this test can supplement therapeutic decision making and should only be used in conjunction with other clinical and laboratory findings. This test is not intended to be used to predict drug response or non-response.