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
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.
High quality in vitro diagnostic test with 100% accuracy and reproducibility3
Detect 17 different mutations/polymorphisms, including gene deletion and duplication
†After allowable reruns
|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|
|*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|
|Luminex Online Order Management|
|Phone:||+31 (0)73 800 1900|
|Fax:||+31 (0)73 800 1998|
|Product Name||Kit Size||Registration Status||Part Number|
|xTAG CYP2D6 Kit v3||48 Tests||CE Marked in EU and
|xTAG CYP2D6 Kit v3 Analysis Software CD*||CE Marked in EU and
|*Only available with the purchase of a kit.|
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 (EU-IVD/SFDA Approved):
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 a whole blood sample. 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 and treatment dose for therapeutics.