Scope Fluidics, a life science company listed on the Warsaw Stock Exchange (WSE), which develops innovative technologies for the medical diagnostics and healthcare market, reports positive results from the Proof of Concept (PoC) for the first phase of work on software aimed at the rapid detection of bacterial growth and determining levels of antibiotic susceptibility. These results confirm that the teams at Scope Fluidics and Bacteromic jointly have the expertise necessary to create panels sought by the market for determining bacterial antibiotic susceptibility within a single laboratory shift, which is less than 8 hours.
In the process, the first version of the software, which cooperates with our UNI Panel, was developed. This integration enables the assessment of bacterial drug susceptibility to up to 31 antibiotics and the identification of one ESBL resistance mechanism all within the timeframe of a single laboratory shift (i.e., 8 hours or less). The results confirm our competence to create a commercial version of this solution and demonstrate the potential for expanding its functionality to include additional antibiotics. Looking ahead, we plan to develop similar solutions for analyzing tests from Positive Blood Cultures and further shortening detection times for bacterial groups, primarily Pseudomonas – says Prof. Piotr Garstecki, CEO of Scope Fluidics.
Details of the Analysis
During the “Proof of Concept” phase, more than 400 clinical bacterial strains were analyzed across five major groups, covering a varied range of growth rates. Essential Agreement (EA) was established at a minimum level of 90%, maintaining other criteria necessary for the registration of the diagnostic method.
For four bacterial groups (Acinetobacter, Enterobacterales, Enterococcus, and Staphylococcus), the BACTEROMIC system provided accurate results within 8 hours or less, with most antibiotics and bacteria yielding results in 6 hours or less. For the fifth main group, Pseudomonas, some results were provided in times exceeding 8 hours. Essential Agreement (EA) is a measure of accuracy that assesses how closely the test method’s results for the minimum inhibitory concentration align with the MIC values obtained by the reference method. MIC values indicate the lowest concentration of an antibiotic that prevents visible growth of the microorganism, and EA reflects the precision of the method in approximating this threshold.
The team’s goal is for the end result of the research and development work to be two new panels named “Panel Rapid BSI” (Panel Rapid Blood Stream Infection enabling testing of positive blood cultures) and “Panel Rapid UNI.” Both panels will require certification in accordance with IVDR requirements involving a notified body.
This marks another important step in our development. The ability to detect bacterial drug resistance to a wide range of antibiotics in less than 6-8 hours will be a significant competitive advantage for the BACTEROMIC system in the M&A process. It is crucial that we have entered the race for quick results equipped with the original assets of the Bacteromic system – immense informational capacity – as the combination of speed and informativeness of the Bacteromic system is unique in the market – emphasizes Szymon Ruta, Vice President of the Board and CFO of Scope Fluidics.
BACTEROMIC – Essential Information
Scope Fluidics owns Bacteromic sp. z o.o., a special purpose entity established for the development of the BACTEROMIC system – a fast, automated Antibiotic Susceptibility Testing (AST) system that provides precise information about which clinically significant antibiotics will be most effective in treating bacterial infections.
The system is characterized by its versatility and range of potential applications, as well as its cost-efficiency, both in terms of the Analyzer and 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 related to antimicrobial resistance: speed, comprehensiveness of information, high throughput, automation of the process, ease of use, and cost-effectiveness.
The system consists of a laboratory analyzer (and a smaller device for automatic filling, used to automatically fill cartridges with samples) and disposable Panels, which can accommodate up to 60 antibiotics in over 600 dilutions, allowing for precise estimation of the minimum inhibitory concentration (MIC). The system is also highly flexible in terms of potential applications, allowing for the use of the current cartridge architecture with various types of samples.
