Bacteromic, a subsidiary of the Scope Fluidics Group listed on the Warsaw Stock Exchange, has received IVDR certification for the BACTEROMIC system with the UNI Panel. This certification enables the BACTEROMIC system to be introduced to the European market.
Receiving the IVDR certificate marks a key milestone in the development of the BACTEROMIC system and confirms its readiness to enter the European market. The effectiveness and precision of the solution, confirmed through studies and the conformity assessment process, provide a solid foundation for commercialization. The certification also confirms compliance with rigorous regulatory requirements, which is of fundamental importance to diagnostic laboratories. We are confident that BACTEROMIC can play a meaningful role in addressing the growing problem of antibiotic resistance by supporting more accurate medical decisions and improving patient treatment outcomes. Obtaining the certificate opens up opportunities to introduce the system in international markets that recognize CE IVDR, build its commercial potential, and increase interest in the project among business and M&A partners. This is undoubtedly another important step for BACTEROMIC following the recent signing of an agreement with a recognized transaction advisor – says Piotr Garstecki, President of Scope Fluidics.
The IVDR certificate was granted for the UNI Panel version covering all 30 notified antibiotics and the corresponding 56 drug-bug combinations, as well as ESBL resistance mechanism detection and software enabling the assessment of antibiotic resistance within 16 hours. The number of combinations exceeds the number of antibiotics because, for some of them, susceptibility is assessed across several groups of bacteria. At the same time, the Bacteromic team is preparing to launch the panel for sale.
Simultaneously with receiving the IVDR certificate for the UNI Panel and the interpreter, the Bacteromic team confirmed that the devices comprising the BACTEROMIC system, namely, the analyzer and the filler, comply with IVDR requirements. Accordingly, the entire system – analyzer, filler, interpreter, and UNI Panel – is CE marked following the conformity assessment and may be placed on the market in the European Union and in countries that recognize IVDR requirements.
The Scope Fluidics Group continues to implement a strategy focused on maximizing the value of the project. Obtaining IVDR certification represents a significant step toward commercialization of the BACTEROMIC system and its further development. The certification significantly strengthens discussions with potential business partners, including distributors in foreign markets, and enhances the project’s attractiveness from an M&A perspective.
The next stage in the project’s development will involve expanding the BACTEROMIC system offering with additional panels, the nearest being FAST UNI. We are also preparing to continue the FDA certification process in the United States for the extended version of FAST UNI, which will include up to 52 antibiotics and three resistance mechanisms. In the meantime, we are focusing on launching the production line and commencing sales of the system based on signed distribution agreements in the Turkish and Romanian markets. Our objective is to consistently move toward full commercialization of the project – adds Piotr Garstecki, President of Scope Fluidics.
