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xTAG® CYP2C19 Kit v3

Pharmacogenetics Testing

Accurate answers on a scalable system for routine CYP2C19 genotyping

Empowering Personalized Medicine

 

xTAG® CYP2C19 Kit v3 is a genotyping panel covering clinically relevant mutations and offering the ability to identify CYP2C19*2 and CYP2C19*3 variants, which together account for approximately 99% of Asian and 87% of Caucasians poor metabolizers, respectively. Over one-third of Caucasians and over 40% of patients of African and Asian ancestry harbor gain-of-function and loss-of-function 2C19 variants.1 These variants are linked to a higher risk of adverse events with certain drugs. The test incorporates multiplex Polymerase Chain Reaction (PCR) and multiplex Allele Specific Primer Extension (ASPE) on the Luminex platforms. The assay automatically determines the diplotype for each sample.

Reliable

Detect and identify clinically relevant genotypes
 

Resource Efficient

Obtain flexibility in throughput with Luminex® 100/200™ platform and/or MAGPIX® instrument

Actionable

Gain confidence in results with high accuracy and reproducibility

Features of the xTAG CYP2C19 Kit v3:

 

  • Genotypes (EU-IVD/SFDA Approved) — *2, *3, *4, *5, *6, *7, *8, *9, *10, *17
  • Instrument & Software — Luminex 100/200 instrument with xPONENT® 3.1 software and MAGPIX instrument with xPONENT 4.2 software.
  • Reproducibility — 100%
  • Kit Accuracy — 100% compared to Dideoxy Sequencing †
  • Optimal Input DNA — 0.5 ng/µL to 300 ng/µL (US)
  • Sample Type — EDTA Blood & Citrate Blood

 

† after allowable reruns

 

 

Alleles and SNPs of the xTAG CYP2C19 Kit v3

 

CYP2C19 Alleles SNP(s) Detected † Predicted Enzyme Activity % Allele Frequency ††
Caucasian African Asian
*2 19154G>A Non-functional 14.7 17.3 30
*3 17948G>A Non-functional 0.04 0.4 5.1
*4 1A>G Non-functional 0.6 NA NA
*5 90033C>T Non-functional NA NA 0.2
*6 12748G>A Non-functional NA NA NA
*7 19294T>A Non-functional NA NA NA
*8 12711T>C Non-functional 0.3 NA NA
*9 12784G>A Decreased function NA 17 NA
*10 19153C>T Decreased function NA NA NA
*17 -806C>T Increased function 18-25 18 1.3-4
† P450-2C19 alleles consist of one or more nucleotide variants. In each case the haplotypes can be represented by one variant which is unique to that allele and is responsible for the observed phenotype.
†† Allele frequency not fully analyzed/reported.

xTAG CYP2C19 Kit v3 Workflow

 

Optimized protocol allowing flexible throughput on the Luminex 100/200 & MAGPIX instruments

  • Utilize the scalability of Luminex instruments to increase throughput effectively
  • Easy to 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

 

CYP2D6 & CYP2C19 Workflow

Ordering Information

 

Luminex Direct Ordering Information
Luminex Online Order Management
Email: [email protected]
Phone: +31 (0)73 800 1900
Fax: +31 (0)73 800 1998
Product Name Kit Size Registration Status Part Number
xTAG CYP2C19 Kit v3 48 Tests CE Marked in EU and
SFDA Approved
I046B0428
TDAS CYP2C19 Kit v3 Analysis Software CD*   CE Marked in EU and
SFDA Approved
S046-0276
*Only available with purchase of the CYP2C19 Kit

xTAG® CYP2C19 Kit v3 Resources

 

xTAG® CYP2C19 Kit v3 (CE Marked in EU/SFDA Approved)Product Information


Performance of the Luminex® xTAG CYP2C19 Kit v3 (EU)Poster


Pharmacogenomic Biomarkers in Drug LabelsFood & Drug Administration

  1. xTAG CYP2C19 Kit v3, Package Insert

 

For In Vitro Diagnostic Use. Products 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 (EU-IVD/SFDA Approved):

he 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 indicated for use with the Luminex® 100/200™ instrument or MAGPIX® with xPONENT® software systems.

xTAG® CYP2C19 Kit v3 is not indicated for stand-alone diagnostic purposes. The information provided from this test might 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.