Bacteromic – a member of the Scope Fluidics S.A. Capital Group – has successfully completed the second series of external pre-validation tests of the BacterOMIC system, which were carried out by the National Tuberculosis and Lung Diseases Research Institute in Warsaw. The results of the tests proved the correct functioning of the system.
The series of tests conducted at the National Tuberculosis and Lung Diseases Research Institute aimed to verify the correct functioning of the BacterOMIC system, which offers revolutionary full antibiotic-susceptibility testing. The Vitek2 system by Biomerieux, a market leader in automatic susceptibility testing, was used as a comparative method in the tests.
In the course of tests conducted at the National Tuberculosis and Lung Diseases Research Institute, 89 clinical bacteria strains were analyzed, which translates into more than a thousand independent antibiotic susceptibility tests. The BacterOMIC quantitative determinations were compared to the results obtained using the popular Vitek2 system. In more than 90% of cases, the results of susceptibility tests were correct, while the Bacteromic system’s determinations were more accurate in a wider range of antibiotic concentrations. The tests confirmed the correctness of the cartridge preparation procedures, cartridge use protocols and the functioning of the entire system, including data analysis modules. For both systems, the percentage of failed tests did not exceed 5%.
We have successfully completed the second stage of BacterOMIC prototype testing in an external target clinical environment. The main aim of this research was to confirm the correctness of the system operation after we had modified its technical elements. The current results and feedback from the target users also provide us with the latest cues on how to design the final version of the BacterOMIC system, says Prof. Piotr Garstecki, co-owner, key shareholder and CEO of Scope Fluidics S.A.
The BacterOMIC system was previously tested in the laboratories of the National Medicines Institute (NIL) in the second half of 2018. The feedback from the first series of tests was implemented to prepare the BacterOMIC system for the next series of external tests. The main challenge for the Company was to expand the panel of antibiotics and introduce changes to the cartridge. Modifications of the system based on the test results were carried out correctly. The BacterOMIC system was assessed by the laboratory staff of the Microbiology Department of the National Tuberculosis and Lung Diseases Research Institute as offering the operation complexity that is comparable to the market methodologies known to them.
According to the plan, the Company is implementing the project schedule which was shortened by 18 months in March 2019 – the expected date of completion of works on the BacterOMIC system (EU certification) is mid-2021. The Company systematically expands the number of antibiotics tested in disposable cartridges. The aim is to develop a panel that will offer the possibility to test all clinically relevant antibiotics in a single trial as well as a panel that will also allow to test the effectiveness of antibiotic combinations.
The company plans to be ready for pre-registration testing in Q1 2020. The launch of a manufacturing line for chips and analyzers as well as pre-registration tests are scheduled for the second half of 2020. The final stage of certification and registration of the system together with its commercialization are planned for the second half of 2021.
The BacterOMIC project is to respond to the growing phenomenon of antibiotic resistance of bacteria. The Company’s product is intended to accelerate and increase the effectiveness of treatment by identifying the best targeted therapies for a given patient. Within a few hours, it will precisely assess the susceptibility of bacteria to all clinically important antibiotics and will provide the physician with extensive information about the pathogen. The Company’s project also has a chance to be the first automatic diagnostic system enabling the testing of antibiotic combinations in cases of the most difficult infections, where no single antibiotics are effective.