Elucigene DPYD assay is a simple genotyping test that can identify patients with DPD deficiency allowing an alternative treatment to be offered
DPYD Genotyping
5-fluorouracil (5-FU) is a chemotherapy agent used to treat a range of cancers including colorectal, head and neck, breast, pancreatic and stomach cancer. 5-FU is metabolized by the dihydropyrimidine dehydrogenase enzyme (DPD) which is encoded by the DPYD gene.
Several variants within DPYD have been described that lead to reduced or abolished DPD activity. Patients with these variants are at an increased risk of severe or fatal 5-FU toxicity. Therefore, implementation of DPD deficiency screening by genotyping will allow a more accurate prediction of toxicity and chemotherapeutic response.
| Allelic Variant | rsID | Nucleotide Change | Protein Change | Allele Function |
|---|---|---|---|---|
| *2A | rs3918290 | c.1905+1G>A | N/A | No Function |
| *13 | rs55886062 | c.1679T>G | p.I560S | No Function |
| N/A | rs67376798 | c.2846A>T | p.D949V | Decreased |
| HapB3 | rs75017182 rs56038477 rs56276561 |
c.1129-5923C>G c.1236G>A c.483+18G>A |
N/A p.E412E N/A |
Decreased Decreased Decreased |
Clinical Guidelines
The Clinical Pharmacogenetics Consortium (CPIC) published a new guideline in 2017 for DPYD genotyping and they recommend testing for the 6 SNPs outlined above. The CPIC guidelines also recommend 5-FU dose based on DPYD genotype.
For further information, please follow this link https://cpicpgx.org/guidelines/guideline-for-fluoropyrimidines-and-dpyd/
Key Features
- Targeted detection of 6 SNPs in the DPYD gene
- Two tube assay
- Tube 1 detects the defined mutations
- Tube 2 detects the corresponding wildtype sequences to detect heterozygotes
- STR markers are included in each tube to aid sample identification
- Ready to use reagents
- Simple data interpretation
- Rapid turnaround time
- Fits with cancer treatment pathway
- 1 day TAT
- Minimal hands on time
- PCR – approx. 3 hours
- Capillary electrophoresis – 1 hour
One PCR
- One or two tube analysis
- Tube A: mutation detection and polyT status
- Tube B: wildtype detection
- Simple PCR set-up
- Reduced hands on time
One Analysis
- No post-PCR manipulation
- Compatible with ABI 3*** Genetic Analysers
- Highly multiplexed 5 dye chemistry
- Rapid Analysis
One Report
- GeneMarker software application
- Easy data review and analysis
- Informative single page reporting
- No data transfer required
Ordering Information
| Kit Name | Description | Platform | Catalogue Code | |
|---|---|---|---|---|
|
Elucigene DPYD, CE-IVD |
DPYD screen testing for *2A, *13, c.2846A>T, HapB3 |
Genetic Analyser |
ONDYDB1 |
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Elucigene kits are developed and manufactured within quality systems accredited to ISO9001:2008 and ISO13485:2003 and are validated as in vitro diagnostic devices in compliance with the European Community Directive 98/79/EC and the Canadian Medical Device Regulations (CMDR). Elucigene is a trademark of Delta Diagnostics (UK) Ltd. ARMS is a trademark of AstraZeneca UK Ltd. GeneMarker is a trademark of SoftGenetics Corporation. VIC®, PET® and NED™ are trademarks of Life Technologies Corporation.
Licensee Kits: This product is sold pursuant to an agreement with Life Technologies Corporation. The purchase of this product conveys to the buyer the non-transferable right to use only the purchased amount of the product and its components only for human in vitro diagnostics, solely for the clinical indication described in the accompanying instructions for use. For information on obtaining rights to use this product or its components, please contact This email address is being protected from spambots. You need JavaScript enabled to view it..