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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.1,2

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  1. 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.
  2. 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.