Bacteromic, a subsidiary of Scope Fluidics Group listed on the Warsaw Stock Exchange, has submitted the documentation required to obtain IVDR certification for the BACTEROMIC system with the UNI Panel.
Submitting the test results marks a key stage in the IVDR certification process and is essential for introducing the BACTEROMIC system to the European market.
“We are consistently advancing our key projects, with the BACTEROMIC system now our top priority. Earlier results from the Early Access program confirmed the solution’s readiness for market entry, and in parallel we are carrying out the IVDR certification process. Submitting the documentation to the notified body is an important step toward the development and commercialization of our breakthrough system. The effectiveness and precision of the BACTEROMIC system, confirmed in clinical studies, give us a strong foundation for launching it on the European market. We believe that BACTEROMIC can provide real support to physicians in addressing the growing problem of antibiotic resistance,” said Piotr Garstecki, CEO of Scope Fluidics.
In accordance with certification requirements, the studies were conducted in cooperation with a Contract Research Organization (CRO). Based on the results, Bacteromic has submitted the BACTEROMIC system for IVDR certification to the notified body with all 30 antibiotics, 56 clinically relevant “drug-bug” combinations identified by the BACTEROMIC team, and one resistance mechanism – ESBL. The number of combinations exceeds the number of antibiotics because, for some antibiotics, the system’s ability to assess susceptibility was tested against several groups of bacteria.
