Bacteromic, a subsidiary of Warsaw Stock Exchange-listed Scope Fluidics Group, has submitted documentation initiating the IVDR certification process for the BACTEROMIC system with the UNI FAST Panel. This is the next step following the IVDR certificate obtained in February for the system with the UNI Panel, which opened the way for the Group to introduce the solution to the European market and strengthened its commercial potential.
“Initiating the IVDR certification process for the UNI FAST Panel is an important element in the further development of the BACTEROMIC system and a confirmation that we are consistently executing our plan to build its value. Having obtained the IVDR certificate for the system with the UNI Panel, we are now focused on introducing its next, faster iteration. The UNI FAST Panel, which enables a significant reduction in the time required to assess antibiotic resistance, has the potential to substantially increase the commercial appeal of the solution as a whole. Obtaining the IVDR certificate for the BACTEROMIC system with the UNI FAST Panel could open up new opportunities for us in international markets, strengthen the system’s commercial potential, and increase interest from strategic partners and investors,” says Piotr Garstecki, CEO of Scope Fluidics.
The UNI FAST Panel submitted for certification covers 24 antibiotics and 48 corresponding drug-bug combinations, enabling antibiotic susceptibility assessment within 6 to 8 hours. Work is continuing in parallel on further expanding the drug-bug combination portfolio, both in the context of future IVDR certification for an expanded version of the panel and in view of U.S. FDA requirements.
The IVDR certificate for the BACTEROMIC system with the UNI FAST Panel is expected by mid-year. It should be noted, however, that during the process the notified body may raise questions about the submitted documentation or require additional testing, which could affect the certification timeline.