ViennaLab Diagnostics GmbH

Determine genetic variants and copy number changes associated with a poor, intermediate or ultra-rapid CYP2D6 metabolizer status.

Differences in the activity of the liver enzyme CYP2D6 contribute to the inter-individual variability in a majority of drug responses.The PGX-CYP2D6 XL StripAssay® in combination with the CYP2D6 RealFastTM CNV Assay detects the most relevant variations (genetic variants as well as copy number changes) in different populations including European, American, Central/South Asian, Latino, Sub-Saharan African, and many more which are associated with a poor, intermediate or ultrarapid CYP2D6 metabolizer status.



  • CYP2D6 is involved in the metabolism of about 25% of all drugs used in the clinic (e.g. tamoxifen, opiates, antidepressives or antipsychotics).
  • CYP2D6 loss-of-function alleles: *3 - *8, *11, *12, *15, *40, *69, *114.
  • CYP2D6 reduced function alleles: *9, *10, *14, *17, *29, *41.
  • CYP2D6 increased function alleles: *1xN, *2xN, *35xN (N= copy number).
  • Clinical guidelines on drug prescription recommendations are listed on PharmGKB:
  • The PGX-CYP2D6 XL StripAssay® in combination with the CYP2D6 RealFastTM CNV Assay identifies patients with altered CYP2D6 enzyme function. This facilitates the choice of medication and/or the adjustment of drug dosage, thereby reducing the risk of adverse events or lowered treatment efficacy.


Assay coverage for the given human populations

European (0.94), African American/Afro Caribbean (0.81), American (0.95), Central/South Asian (0.94), East Asian (0.92), Latino (0.93), Near Eastern (0.94), Oceanian (0.98), Sub-Saharan African (0.84).


ProductReg. Stat.REFUnit SizeIFUBrochure
PGX-CYP2D6 XL StripAssay® CE/IVD4-77020 tests



CYP2D6 RealFast™ CNV Assay CE/IVD7-420100 rxn



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