15.01.2020

Scope Fluidics ready for BacterOMIC system industrialisation

Bacteromic – a member of the Scope Fluidics S.A. Capital Group – announced the completion of another, fourth milestone of the BacterOMIC project, under which the system has been prepared for industrialization and a chip manufacturing line design has been developed. The project is being implemented according to the updated schedule on the basis of which the Company planned to commercialise the system in mid-2021.

The Bacteromic sp. z o.o. team has completed works on the design of the entire system’s production version. A new version of the chip has been developed, optimized in terms of ergonomics of use and manufacturing cost, and a design of the manufacturing line for chips was made. Works on the design of the filling machine and analyser cooperating with the new chip were also completed.

We are implementing the next stage of the BacterOMIC project on time. Today we are ready to industrialize the system. The results of the system tests in Scope Fluidics laboratories, in the National Medicines Institute and in the National Tuberculosis and Lung Diseases Research Institute allowed us to optimize the ergonomics and at the same time introduce changes aimed at simplifying the manufacturing process. The design team works very efficiently and systematically develops the product, says Prof. Piotr Garstecki, co-owner, key shareholder and CEO of Scope Fluidics.

In December 2019 Scope Fluidics successfully obtained PLN 13.9 million to develop its projects. 5 million PLN of this amount, together with approximately 8 million PLN (1.93 million EUR) obtained from the prestigious Horizon 2020 grant, are to enable the BacterOMIC system to be certified in the European Union in mid-2021, which will be tantamount to the system being ready for commercialization.

Thanks to the public funds and capital obtained from investors, we have ensured the financing of the project. We have already smoothly proceeded to the realisation of the next milestone, the direct aim of which is to prepare the system for clinical pre-registration tests in external laboratories. We expect to achieve it already in Q1 2020, adds Piotr Garstecki.

The current stage will include completion of 2-3 devices and injection moulds for chip manufacturing. A pilot line will be launched, which will allow to produce chips with reagents in the amount that is  necessary to conduct the third series of pre-registration tests in Q2 2020. In the second half of 2020 the company plans to launch a manufacturing line for chips and analysers and to conduct pre-registration tests. The final stage of certification and registration of the system is planned for the second half of 2021. Then, the system is planned to be commercialized.

In November 2019, Scope Fluidics successfully completed tests of the BacterOMIC system at the Microbiology Department of the National Tuberculosis and Lung Diseases Research Institute in Warsaw. 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 more than 90% of cases, the results of susceptibility tests were correct, and the Bacteromic system’s results were more accurate in a wider range of antibiotic concentrations. The tests confirmed the correctness of the chip preparation procedures, chip use protocols and the functioning of the entire system, including data analysis modules.

A year earlier, in November 2018, Scope Fluidics announced the completion of the first functionality tests of the BacterOMIC system’s prototype, conducted by the National Medicines Institute (NIL). These tests allowed for a comprehensive evaluation of the entire system and demonstrated its ability to correctly determine the drug susceptibility of the microorganisms. According to the NIL report, the BacterOMIC system conducted all the planned tests according to the procedure. The handling procedure and prototype ergonomics were evaluated positively. The system correctly determined the antibiotic susceptibility levels for all tested bacteria and antibiotics on the panel.

The BacterOMIC project is intended to respond to the growing phenomenon of antibiotic resistance, which is today recognized by the World Health Organization (WHO) as one of the world’s greatest threats to public health – estimates indicate that drug-resistant bacteria could lead to the death of up to 300 million people worldwide in the next 35 years. Already today, 70% of infections in Europe are resistant to at least one antibiotic.

The Company’s product is intended to accelerate and increase the effectiveness of patient treatment by identifying the best targeted therapies for a given patient. Within a few hours, it will precisely assess the susceptibility of the bacteria to all clinically important antibiotics and provide the physician with extensive information about the pathogen. The BacterOMIC system will use classic microbiological methods to perform antibiotic susceptibility testing, combined with the innovative microfluidic technology. The main competitive advantage of the BacterOMIC system will be much greater complexity of the test than in case of other systems available on the market. Moreover, this project has a chance to become the first automatic diagnostic system for testing combinations of antibiotics in the most difficult infections, where no single administered antibiotics are effective. BacterOMIC attracts a vivid interest of the clinical microbiology environment. In 2019, the project was classified among seven breakthrough diagnostic products at the American Association of Clinical Chemistry trade fair  and the Company was invited to present the system at conferences in Berlin, Los Angeles, Washington and Amsterdam. The interest of clinicians and diagnosticians gives us a lot of motivation to work on the system, adds Seweryn Bajer Borstyn, PhD, BacterOMIC product manager.