5FU DPYD Stripassay
The Viennalab PGX-5FU DPYD XL StripAssay determines the DPYD genotype for the four variants with established relevance for fluoropyrimidine treatment: c.1236G>A (HapB3), c.1679T>G (DPYD*13), c.1905+1G>A (DPYD*2A) and c.2846A>T (p.D949V). Fluoropyrimidines such as 5-fluorouracil, capecitabine and tegafur are widely used in cancer therapy. Variants in the DPYD gene lower the activity of dihydropyrimidine dehydrogenase, the enzyme that clears these drugs, and carriers are at risk of severe treatment-related toxicity. Genotyping before the first dose is recommended by the European Medicines Agency and by the CPIC guideline for fluoropyrimidines.
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This kit in detail
- Four DPYD variants: HapB3, *13, *2A and p.D949V
- Identifies carriers at risk of fluoropyrimidine toxicity
- Supports genotype-guided dosing per EMA and CPIC
- Reverse hybridisation on a test strip
- Whole blood, with lysis solution and resin included
- 20 tests per kit, REF 4-780
The Viennalab PGX-5FU DPYD XL StripAssay determines the DPYD genotype before treatment with a fluoropyrimidine, so that the starting dose can be adjusted to the metabolic capacity of the patient.
Clinical background
5-fluorouracil, capecitabine and tegafur are converted by dihydropyrimidine dehydrogenase (DPD). Variants in the DPYD gene reduce the activity of this enzyme, the drug accumulates, and the patient develops treatment-related toxicity that can be severe. The European Medicines Agency and the CPIC guideline for fluoropyrimidines therefore recommend determining the DPYD genotype before the first dose.
Variants covered
The strip covers c.1236G>A (HapB3), c.1679T>G (DPYD*13), c.1905+1G>A (DPYD*2A, also written IVS14+1G>A) and c.2846A>T (p.D949V). Together these four account for the majority of reduced-function alleles reported in European populations.
Method
The assay uses PCR amplification with biotinylated primers followed by reverse hybridisation to probes immobilised on a test strip, with a colour reaction for detection. The kit contains the lysis solution and GENxTRACT resin for releasing DNA from whole blood; further DNA extraction reagents are not supplied with the kit, and ViennaLab recommends the Spin Micro DNA Extraction Kit (REF 2-020) or the GENxTRACT Blood DNA Extraction System (REF 2-014), ordered separately.
- Lysis Solution (50 ml)
- GENXTRACT Resin (5 ml)
- Amplification Mix (yellow cap, 500 µl)
- Taq Dilution Buffer (transparent cap, 500 µl)
- Taq DNA Polymerase (5 U/µl, red cap, 75 U)
- DNAT (blue cap, 1.5 ml)
- Typing Trays (3)
- Teststrips (20)
- Hybridization Buffer (white cap, 25 ml)
- Wash Solution A (white cap, 80 ml)
- Conjugate Solution (25 ml)
- Wash Solution B (80 ml)
- Color Developer (25 ml)
- Instructions For Use (1)
- Collector Sheet (1)
Kit for 20 tests, REF 4-780. DNA extraction reagents are not supplied with the kit. ViennaLab recommends the Spin Micro DNA Extraction Kit (REF 2-020) or the GENxTRACT Blood DNA Extraction System (REF 2-014), which are ordered separately.
Datasheets and regulatory documentation
Everything your quality team needs for evaluation and procurement.
Instructions for Use
CPIC Guideline
Frequently paired with this kit
Other assays and instruments lab teams add alongside the 5FU DPYD Stripassay.
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