CYP2D6 PCR Assay
The Viennalab CYP2D6 CNV RealFast Assay determines the CYP2D6 copy number by real-time PCR, distinguishing deletion (the *5 allele), two copies and duplication, in order to establish poor, intermediate or ultrarapid metaboliser status. CYP2D6 is involved in the metabolism of approximately 25 per cent of drugs used in the clinic, including tamoxifen, opiates, antidepressants and antipsychotics, and variation in the gene contributes to differences in drug response between patients. In Europe, approximately 6 per cent of people are poor metabolisers, 7 per cent intermediate metabolisers and 3 per cent ultrarapid metabolisers. Clinical guidelines for the drugs concerned are listed in PharmGKB.
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This kit in detail
- Deletion (*5), two copies or duplication of CYP2D6, including *1xN, *2xN and *35xN
- Establishes poor, intermediate and ultrarapid metaboliser status
- CYP2D6 metabolises approximately 25 per cent of clinically used drugs
- European frequencies: 6 per cent poor, 7 per cent intermediate, 3 per cent ultrarapid
- Real-time PCR, whole peripheral blood or buccal swabs
- 100 reactions per kit
The Viennalab CYP2D6 CNV RealFast Assay determines copy number changes in the CYP2D6 gene, which are used to establish metaboliser status.
Clinical background
CYP2D6 is involved in the metabolism of approximately 25 per cent of drugs used in the clinic, including tamoxifen, opiates, antidepressants and antipsychotics. Genetic variation in the gene contributes to differences in drug response between patients, so identifying altered enzyme function supports both the choice of drug and the adjustment of its dose, and lowers the risk of adverse events or reduced efficacy.
Copy number and metaboliser status
Increased function results from gene duplication or multiplication, denoted *1xN, *2xN and *35xN, where N is the copy number. Approximately 6 per cent of Europeans are poor metabolisers, 7 per cent intermediate metabolisers and 3 per cent ultrarapid metabolisers. Clinical guidelines for the drugs concerned are listed in PharmGKB.
Method
The assay uses real-time PCR with the RealFast 2x Probe Mix and the CYP2D6 CNV Assay Mix, together with a CNV calibrator. It distinguishes deletion, two copies and duplication, and identifies heterozygous and homozygous deletion, the *5 allele. Only the total copy number is determined: a duplication on one chromosome combined with a deletion on the other cannot be resolved. DNA isolated from whole peripheral blood or buccal swabs can be used, and DNA extraction reagents are not supplied with the kit; ViennaLab recommends the Spin Micro DNA Extraction Kit (REF 2-020), ordered separately.
Combination with the StripAssay
Copy number analysis covers duplications and multiplications. For the reduced-function and loss-of-function alleles, this assay is combined with the CYP2D6 StripAssay, which genotypes those variants.
- RealFast 2x Probe Mix (white cap, 1000 µl)
- CYP2D6 CNV Assay Mix (purple cap, 550 µl)
- CYP2D6 CNV Calibrator (green cap, 75 µl)
REF 7-420 (100 reactions). DNA extraction reagents are not supplied with the kit. ViennaLab recommends the Spin Micro DNA Extraction Kit (REF 2-020), which is ordered separately.
Datasheets and regulatory documentation
Everything your quality team needs for evaluation and procurement.
Instructions for Use
Frequently paired with this kit
Other assays and instruments lab teams add alongside the CYP2D6 PCR Assay.
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