Bacteromic – a member of the Scope Fluidics S.A. Capital Group – has announced the commencement of the sixth stage of the BacterOMIC project, i.e. starting the process of verifying the performance of individual elements of the system under preset protocols and specifications. Preregistration tests of the BacterOMIC system in clinical laboratories will be the next step.
The Bacteromic project team has completed a series of works in order to prepare the system for regulatory tests, such as: optimizing the analyzer design to improve the ergonomics of use and introducing numerous changes which simplify the methods of work with antibiotics and the system manufacture process. Furthermore, in the process of these works, over 90-percent compliance with the reference method for type strains has been validated for another group of antibiotics. By the end of last year, as many as 30 antibiotics have met the aforementioned criteria.
– We are now executing the last stage of work within the sixth milestone. In the last months, we have been intensely preparing the BacterOMIC system for the clinical regulatory tests. At present we are in the process of verification of the system, which will confirm proper performance of system elements in line with the applicable protocols and directives. At a later stage, we are planning clinical validation i.e. conducting preregistration regulatory tests of the system in clinical centers engaged in testing the drug resistance of germs. The first tests will soon be carried out in our microbiological laboratories – explains Dr Seweryn Bajer-Borstyn, Bacteromic product manager.
After completing the preregistration regulatory tests, the Company will have the system registered for use in medical diagnostics in the European Union, with the estimated date of completion at the end of Q2 2021.
In mid-December 2020, the Company has received a conditional decision from the European Patent Office (EPO) to grant a patent on the innovative solution applied in the BacterOMIC system, i.e. the geometry of a single incubation segment in a microfluidic chip for microbiological tests. This is the second European patent granted this year to BacterOMIC, and the registration of the incubation segment is a key patent securing the technology of the system on the international market.
The BacterOMIC project is a response to the growing phenomenon of antimicrobial resistance, which is viewed by the World Health Organization (WHO) as one of the greatest threats to public health in the world. Estimates suggest that in the coming 35 years, drug-resistant bacteria may cause the deaths of as many as 300 million people worldwide. Even now, 70 percent of infections in Europe are resistant to at least one antibiotic.
The principal competitive advantage of the BacterOMIC system is that it offers much more comprehensive testing than in other systems available on the market. The Bacteromic system offers an exceptionally wide range of antibiotics tested using the quantitative method in every single test, as well as a very wide scope of antibiotic concentrations. Additionally, the Company is also planning to develop a testing panel for testing antibiotic combinations for the cases of most severe infections in which antibiotics are administered one at a time and are not effective. This is also a response to the global need for more informative tests on antimicrobial resistance of bacterial pathogens, caused by the growing incidence rate of antibiotic-resistant infections.