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DryFlowEx PNH High-Sensitivity Assay Kit is now IVDR compliant

Let us remind you that we have already written in the detail about the background of paroxysmal nocturnal hemoglobinuria (PNH), about the principles of PNH detection in erythrocytes, monocytes and neutrophils (see Blog). 

We have also discussed pitfalls of sales to individual countries of the world and the use of both variants with regulation CE IVD (ED7750) and RUO (ED7787) (see Blog).
Furthermore, the kit has been developed according to ICCS/ESCCA consensus guidelines (see below for part 1 - 4).
 
PNH-blog_doprovodny-OBR.jpgIn this part, we would like to focus on the first year-on-year data of this product sales and also on the fact that it is now IVDR compliant. 

We can simply say that this product belongs to one of the best jumpers of the last year. Year-on-year sales increased more than three times (2023 / 2024). Moreover, in the first two months of 2025, the same amount was sold as in the entire year 2023.

We supplied the kit to Europe and Asia last year. 25% was direct sales within the Czech Republic. The majority, almost 60% of sales, went to Europe, either directly or through a distribution channel. The remaining 15% was sold through distributors to Asia.

As we mentioned, sales in 2025 are still growing and we will do everything we can to keep this "jumper" in good condition, of course. 😀

 

DryFlowEx PNH High-Sensitivity Assay Kit is now IVDR compliant. What are the benefits for the customer?

  • Simplifying product implementation into laboratory testing methods.
  • No need to set up and maintain verification compared to Laboratory Developed Tests, reducing overall testing costs.
  • Notified body supervision of the production and logistics of the product as well as any changes.
  • Utilization of the uniform identification using UDI.
Thanks to these advantages, this product has an easier path to further customers.

...........................................................
ICCS/ESCCA consensus guidelines: part 1 - clinical utility
ICCS/ESCCA consensus guidelines: part 2 - reagent selection and assay optimization for high-sensitivity testing
ICCS/ESCCA consensus guidelines: part 3 - data analysis, reporting and case studies
ICCS/ESCCA consensus guidelines: part 4 - assay validation and quality assurance
 
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