Our DPD4var, DPD5var and NUDT15 kits are now CE-IVDR!
Dear Partners,
We are pleased to announce that our DPD4var, DPD5var (for detecting individuals with DPD deficiency – dihydropyrimidine dehydrogenase), and NUDT15(pharmacogenetic test for thiopurine metabolism) kits are now CE IVDR certified.
What it means for you
- Enhanced Safety and Reliability
- CE-IVDR certification ensures these tests meet strict European standards for performance and quality in in vitro diagnostics.
- Guaranteed Regulatory Compliance
- Your laboratories can now use these kits with full confidence, knowing they comply with the new IVDR regulation.
- Proven Effectiveness
- DPD4var & DPD5var: Accurately identify mutations affecting the DPD enzyme, essential for metabolizing fluoropyrimidine-based treatments.
- NUDT15: Detects high-risk non-functional alleles (*3, *6, *9) associated with thiopurine intolerance, especially common in certain populations.
Staying at the Forefront: How Is DPD4var Different from DPD4mut?
Recent international recommendations now advise direct genotyping of theintronic variant rs75017182, instead of rs56038477. This changeis based on new data showing that the two variants forming HapB3 are not always inherited together and that rs75017182 is the actual functional variant. It causes altered DPD enzyme activity, while rs56038477 is only an indirect marker. By directly targeting the causal mutation, our DPD4var kit offers more reliable patient detection and effectively helps prevent fluoropyrimidine toxicity.
CPIC® Guideline for Fluoropyrimidines and DPYD – CPIC
Spotlight on LAMP Technology
All these kits use our LAMP (Loop-mediated IsothermalAmplification) technology:
- Fast results directly from the blood tube (under 1 hour).
- No tedious DNA extraction required.
- Reliability and accuracy suited to your clinical lab needs.
Benefits for Your Laboratory
Speed : Optimal time savings thanks to a simple, efficient protocol.
Easy Integration : Compatible with your existing qPCR platforms.
Certified Quality : Improved diagnostic reliability.
User Support : Full professional support from our team.
Next Steps
- Personalized Demo : Contact us for a tailored presentation based on your equipment.
- On-site Trial : We can arrange a pilot trial in your lab.
- Training : Our experts canvisit to train your teams for optimal kit use.
For more information or to schedule a demonstration, feel free to reach out directly.
Best regards,
The LaCAR MDx Team