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.
BACTEROMIC – Key Facts
Scope Fluidics owns the special purpose company Bacteromic sp. z o.o., established to develop the BACTEROMIC system – a rapid, automated Antibiotic Susceptibility Testing (AST) system that delivers precise information on which clinically relevant antibiotic will be most effective in treating a bacterial infection.
The system is distinguished by its versatility and broad range of potential applications, as well as high cost-effectiveness in respect of both the analyzer and the single-use cartridges. BACTEROMIC has the potential to position itself as the gold standard among existing and other new innovative AST solutions, meeting the needs of all stakeholders concerned with antimicrobial resistance: speed, comprehensive information, high throughput, process automation, ease of use, and cost-effectiveness.
The system consists of a laboratory analyzer (and a smaller filling device used for the automatic filling of cartridges with samples) and single-use Panels, which can accommodate up to 60 antibiotics – each at several to more than a dozen dilutions – enabling precise determination of the minimum inhibitory concentration (MIC). The system is also highly flexible in terms of potential applications, allowing the current cartridge architecture to be used with different sample types.
