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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 (US-IVD/CA-IVD) — *2, *3, *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 AllelesSNP(s) Detected †Predicted Enzyme Activity% Allele Frequency ††US-IVD,
Health-Canada
CaucasianAfricanAsian
*219154G>ANon-functional14.717.330
*317948G>ANon-functional0.040.45.1
*17-806C>TIncreased function18-25181.3-4
† 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

 

  • 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 Direct 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 NameKit SizeRegistration StatusPart Number
xTAG CYP2C19 Kit v348 TestsUS-IVDI046B0427
xTAG CYP2C19 Kit v348 TestsCA-IVDI046B0432

xTAG® CYP2C19 Kit v3 Resources

 

xTAG CYP2C19 Kit v3 (US-IVD)Product Information


xTAG CYP2C19 Kit v3 (US)Brochure


Pharmacogenomic Biomarkers in Drug LabelsU.S. Food & 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 (US-IVD/CA-IVD):

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. 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.

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 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.