14.04.2020

Scope Fluidics launches the BacterOMIC system prevalidation process

Bacteromic – a member of the Scope Fluidics S.A. Capital Group – is working according to the assumed schedule and has announced the achievement of another, fifth milestone of the BacterOMIC project. As a result of the completed activities, the Company is ready to carry out internal prevalidation tests of the system, followed by pre-registration tests in clinical centres involved in the performance of antimicrobial susceptibility tests.

The Bacteromic team, as part of the implemented milestone, completed the first stage of the system industrialization. The company created sets of devices and cartridges in the production version. The design of the analyser and the device for filling cartridges with samples was optimized in terms of the production process and production cost. The cartridges were also redesigned with respect to ergonomics, as a result of which the protocol of manual activities performed by persons conducting diagnostic tests using the Bacteromic system was significantly simplified. Thanks to the recently completed works, the Company has all the elements of the BacterOMIC system necessary to conduct prevalidation tests.

In addition, the BacterOMIC project team has developed analytical methods in the machine learning technology based on artificial neural networks, which can be used for effective and early classification of signals recorded from system cartridge incubation chambers.

The development of the BacterOMIC system is proceeding smoothly. The design team systematically optimizes and adjusts the product to match the final production parameters. All the work that was carried out on the last couple of months was aimed at preparing the improved version of the system, which will soon be used for pre-registration tests. However, before this happens, we want to internally test the optimized system and then confirm its readiness and assumed functionality in clinical trials, says Prof. Piotr Garstecki, co-founder, key shareholder and CEO of Scope Fluidics.

As a result of these efforts, Bacteromic has developed a method of mass production of cartridge components, adapted its own infrastructure to fill optimized cartridges with antibiotics, and produced 100 new cartridges with applied antibiotics, which is a quantity that is sufficient to start prevalidation tests. The first stage of the tests will be conducted at the Company’s headquarters and is aimed at adapting analytical methods to the new version of the system. The tests will be conducted using reference strains recommended by EUCAST and clinical strains stored in the Company’s microbiological bank. After this stage, the clinical value of the system will be assessed in the target environment, i.e. in a diagnostic or scientific research laboratory that routinely performs microbial susceptibility tests (pre-registration tests).

At the end of last year, the Company successfully completed system tests in the Department of Microbiology of the National Tuberculosis and Lung Disease Institute in Warsaw. The tests were aimed at verifying the correct operation of the BacterOMIC system by comparing the parameters with the competitive system, which is currently the market leader in automatic drug susceptibility testing. 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 system research so far has confirmed the possibility to analyse the synergy between multiple pairs of antibiotics in the automatic test, which is a key value distinguishing the BacterOMIC system from the competitive solutions.

The BacterOMIC project is being implemented according to an accelerated schedule, on the basis of which the Company plans to commercialize the system in mid-2021. For the development of the project, the Company obtained financing from investors and from the prestigious European grant SME-Instrument in the total amount of about PLN 13 million.

We are very pleased with the rapid development of the BacterOMIC system to the product stage and its registration. BacterOMIC offers much more informative testing for bacterial susceptibility, and we receive a considerable interest in this solution from clinicians – so we want to bring the system into use as soon as possible, says Seweryn Bajer-Borstyn, Bacteromic product manager.