Scope Fluidics, listed on the Warsaw Stock Exchange (WSE), a life sciences company developing innovative technologies for the medical diagnostics and healthcare market, has received Early Access Program (EAP) results that demonstrate the BACTEROMIC system’s readiness for broader market deployment and confirm its significant competitive advantages.
The outcomes of the Early Access Program (EAP) are further confirmation of the maturity of our strategic project. BACTEROMIC, a rapid, comprehensive, and automated system for testing bacterial infections’ antibiotic susceptibility, has once again proven its competitive advantages, as well as the quality and consistency of its cartridge production. The results obtained from EAP conclusively validate the advantages and quality of the BACTEROMIC system in the eyes of clinical microbiology market experts. Completing the Early Access Program also marks a significant milestone in the commercialization and launch of our system for sale, says Professor Piotr Garstecki, CEO of Scope Fluidics.
The EAP was conducted in the microbiological laboratories of two Polish facilities. Studies were performed concurrently on the BACTEROMIC system and a leading competing system.
The results were analyzed based on samples covering five bacterial groups: Enterobacterales, Staphylococcus, Enterococcus, Acinetobacter, and Pseudomonas. The results presented include comparisons for 19 antibiotics featured on both systems’ panels and one ESBL mechanism (a bacterial resistance mechanism to antibiotics).
Based on the tests, the essential agreement (EA) and category agreement (CA) between the BACTEROMIC system and a reference system (a commercial system available on the market) were calculated. BACTEROMIC demonstrated high values of essential agreement (≥93% for both Gram-negative and Gram-positive bacteria) and category agreement (≥96% for Gram-positive and ≥94% for Gram-negative bacteria). Thanks to the unique informational capacity of its panels, the BACTEROMIC system precisely measured the MIC (minimum inhibitory concentration) for 96% of the determinations. In contrast, the reference system reported this value for 38% of determinations.
It is also noteworthy that the EAP results are satisfying because they demonstrate significant competitive advantages of our system. We believe that the BACTEROMIC system may also play an important role in more effectively managing bacterial drug resistance in the future, assesses Marcin Izydorzak, Vice President of the Management Board at Scope Fluidics.
The team working on the BACTEROMIC system plans to conduct additional external verifications, both domestically and internationally.
BACTEROMIC – What You Need to Know About the System
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, and cost-efficiency both in terms of the Analyzer and disposable 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 involved in 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 precise estimation of the minimum inhibitory concentration (MIC) of bacteria growth. The system is also highly flexible in terms of potential applications, allowing the use of the current cartridge architecture with various types of samples.
