Bacteromic, a subsidiary of Warsaw Stock Exchange-listed Scope Fluidics Group, has received IVDR certification for the BACTEROMIC system with the UNI FAST Panel. This marks another significant step – following the IVDR certification for the system with the UNI Panel granted in February this year – and opens the way for the Group to introduce the solution to the European market while strengthening its commercial potential.
“We believe that the BACTEROMIC system will provide enormous support in the fight against the increasingly prevalent problem of antibiotic resistance, contributing to more accurate medical decisions and improved patient outcomes. Obtaining IVDR certification for the UNI FAST Panel is a significant step in the further development of the system and in implementing the plan to build its value. This Panel enables antibiotic susceptibility to be assessed in just 6-8 hours, which can substantially strengthen the commercial potential of the entire project and aligns with the expectations of strategic partners,” said Piotr Garstecki, CEO of Scope Fluidics.
The UNI FAST Panel covers 24 antibiotics and 48 corresponding antibiotic-bacteria combinations (known as drug-bug combinations), and enables antibiotic susceptibility assessment in 6-8 hours. The next stage in the BACTEROMIC project will be the FDA certification process in the United States for an expanded FAST UNI version, which will cover up to 52 antibiotics and 3 resistance mechanisms.
Scope Fluidics Group is consistently executing its strategy aimed at maximizing the value of the project, and IVDR certification represents a significant step toward the commercialization of the BACTEROMIC system and its continued development.
