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Pharmacogenetics · DPYD
TruPCR Distributed by Goffin Diagnostics

DPYD Testing Kit

The TruPCR DPYD Mutation Detection Kit detects the four clinically actionable variants in the DPYD gene by allele-specific real-time PCR: c.1905+1G>A (rs3918290, DPYD*2A), c.1679T>G (rs55886062, DPYD*13), c.2846A>T (rs67376798) and c.1129-5923C>G (rs75017182, HapB3). Carriers of these variants have reduced dihydropyrimidine dehydrogenase activity and are at risk of severe toxicity from 5-fluorouracil, capecitabine and tegafur. Genotyping before the first dose is recommended by the European Medicines Agency and by CPIC.

Real-Time PCR CE-IVD TruPCR 1 Unit (48 Reactions), 1 Unit (96 Reactions)
Technique
Real-Time PCR
Brand
TruPCR
Packaging
1 Unit (48 Reactions), 1 Unit (96 Reactions)
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Product details

This kit in detail

  • Four DPYD variants: DPYD*2A, DPYD*13, c.2846A>T and HapB3
  • Allele-specific ARMS PCR with fluorescent probes
  • Internal control and positive control included
  • Blood, bone marrow or FFPE tissue
  • Supports genotype-guided fluoropyrimidine dosing per EMA and CPIC
  • 48 or 96 reactions per kit, REF 3B1429 and 3B1430

The TruPCR DPYD Mutation Detection Kit determines the DPYD genotype before treatment with a fluoropyrimidine, so the starting dose can be matched to the metabolic capacity of the patient.

Clinical background

Dihydropyrimidine dehydrogenase clears more than 80 per cent of an administered fluoropyrimidine dose in the liver. Variants that lower or abolish that activity let the drug accumulate, with severe neutropenia, mucositis and diarrhoea as consequences, and in the most severe cases a fatal outcome. 5-fluorouracil, capecitabine and tegafur are used in colorectal, breast, and head and neck cancer, so the number of patients concerned is large.

Variants covered

c.1905+1G>A (rs3918290, also written IVS14+1G>A, DPYD*2A); c.1679T>G (rs55886062, DPYD*13); c.2846A>T (rs67376798); and c.1129-5923C>G (rs75017182, HapB3). These are the four variants for which the CPIC guideline gives dosing advice and which the European Medicines Agency names in its recommendation.

Method

Allele-specific ARMS PCR with fluorescent probes, on DNA from blood, bone marrow or formalin-fixed paraffin-embedded tissue. The kit includes an internal control and a positive control, and the manufacturer states validation on the common real-time PCR platforms.

Documentation

Datasheets and regulatory documentation

Everything your quality team needs for evaluation and procurement.

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