gb PHARM DPYD*2A
Detection method:
allelic discrimination
This in vitro diagnostic kit is intended for detection of mutation DPYD*2A (IVS14+1G>A) in gene for dihydropyrimidine dehydrogenase in human genomic DNA by real-time PCR method (allelic discrimination).
Clinical implications of the CE IVD kit
Fluoropyrimidines (5-fluorouracil and its prodrugs capecitabine and tegafur) are the basic drugs used in chemotherapy of gastrointestinal cancer. Their use is limited by development of many toxic effects including life-threatening myelosuppression. Dihydropyrimidine dehydrogenase (DPD) catalyzes the initial step of pyrimidines catabolism.
It inactivates fluoropyrimidine chemotherapeutics and its activity influences the frequency of toxicity. It is not recommended to administer the fluoropyrimidines to the patients with DPD deficiency. When studying polymorfisms of the gene for DPD (DPYD), the relationship between presence of particular mutations and decreased activity of DPD has been demonstrated. The allelic variant DPYD*2A (rs3918290) is the thoroughly studied mutation of DPYD. Its presence results in production of nonfunctional enzyme that is considered as the essential cause of the fluoropyrimidines toxicity. When the presence of mutated allele in the patient genome is proven, dose reduction or alternative chemotherapy is recommended.
Parameters of the real-time PCR diagnostic kit
- ready-to-use assay
- sample concentration 1-100 ng/µl
- positive and negative controls included
- FAM and HEX channels detection
- identical amplification profile as gb HEMO, gb GENETIC, gb PHARM kits
Validated for:
ABI 7500/7500 Fast (ABI)
ABI 7900HT (ABI)
AriaMx (Agilent Technologies)
CFX96/96Touch (Bio-Rad)
iCycler iQ5 (Bio-Rad)
Light Cycler 480/Cobas z480 (Roche Diagnostics)
MIC (BMS)
QuantStudio 5 (Applied Biosystems)
RG 3000 (Corbett Research)
RG 6000/Q (Corbett Research/Qiagen)