CLIA enters its third year with more than 50 developed parameters, IVDR certification and a strong professional team
In a nutshell:
The CLIA solution, as a result of the cooperation of leading European biotechnological companies, has had its first successes on the market, it presents itself with a constantly growing extensive portfolio with expanded testing options and IVDR certification, which is a guarantee of high test quality.This year we will celebrate the third year of operation of our key CLIA project on the market. So far, we have already managed to develop over 50 parameters for the KleeYa® platform, which offer our customers extended testing options, in addition to several different diagnostic panels.
European solutions for customers all over the world
We are proud to have been able to bring this complex project, which is the result of the cooperation of leading European biotechnology companies, to the markets of several continents and offer our solution to customers all over the world.
A number of satisfied customers at prestigious workplaces are already using the KleeYa® platform, as are the employees of the Allergology and Immunology Laboratory of IFCOR.
“Installation of the KleeYa®️ device in our laboratory by TestLine Clinical Diagnostic s.r.o. took place very quickly and comfortably in May 2023, including the training of the operating staff. Communication with the company was always at a high level. Working with the analyzer is very user-friendly, and the speed of the examination is also a significant benefit, which is appreciated especially by our doctors,” comments on the cooperation Iveta Zapletalová MSc, expert head of the laboratory.
And what do they say about CLIA solution at other prestigious workplaces?
Continuous development of new CLIA parameters
In the CLIA project, we have a vision of a constantly growing portfolio with a clear goal – to offer our customers the most comprehensive solution with expanded testing options, full automation and personalization, both for small and large laboratories.
And in order to live up to this vision this year as well, in the following months we are coming to the market with additional CLIA kits that are currently in the process of registration according to the IVDR.
Specifically, with the KleeYa® platform, we can look forward to:
CLIA Tetanus Toxoid IgG
CLIA Mycoplasma IgA, IgG and IgM
CLIA HSV 1+2 IgG and IgM
CLIA VZV IgA, IgG and IgM
Immunology, endocrinology and oncology kits are in the development phase.
And what are we planning next? You can find out in the CLIA parameters map.
Quality guarantee now also according to IVDR
It’s no secret that certification according to the IVDR is a very complicated process that, according to the new European legislation, every producer of diagnostic kits must undergo. We have also made great efforts to comply with the rules of the IVDR regulation, and in the past year we have set everything up to ensure a continuous supply of quality products to our customers.
And so regularly, before the launch of each CLIA kit on the market, the preparation of technical documentation and certification of a new product according to the IVDR takes place in our company.
Read more about the first IVDR certification of our products in the article
The quality of the product depends on the quality of the entire team and background
The CLIA solution is the result of long-term close cooperation between the companies of the BioVendor Group – TestLine, DiaSource and BioVendor R&D and our partners Stratec and Diatron, who are producers of the KleeYa® automated platform.
The entire team of BioVendor Group, which is behind the development, production, quality control and application-service services of CLIA, today counts more than 100 employees who work together in three development and production workplaces equipped with highly modern technologies in order to maximize the efficiency of our activities.
We would like to express our appreciation
A big thank you to all colleagues who have participated in the CLIA project over the past years, from development to application-service support. The successes to date are undoubtedly based on their efforts, persistence and professionalism.
Last but not least, we would also like to thank all users for their feedback and suggestions, which are very valuable for the further development and improvement of the CLIA solution.
Contact us
We base the quality of our cooperation on a personal approach, and we would be happy to personally present our CLIA solution at your workplace as well.
If you are interested in a presentation of the solution, consultation, personal meeting or a visit to our facilities for the development and production of CLIA kits at BioVendor Group, please do not hesitate to contact us.
