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BacterOMIC system on the run-up to the medical diagnostics market authorization

Bacteromic Sp. z o.o., a company being a part of Scope Fluidics S.A. Group, has completed the validation tests under the BacterOMIC system’s first round of proper pre-registration testing. The results obtained are the grounds for acquiring the CE-IVD certificate, thanks to which the system can be introduced into the European Union’s market. In accordance with the presented plan of further development, BacterOMIC will make it possible to run Early Access tests in diagnostic facilities. In comparison to the reference method, the BacterOMIC system demonstrated over 90% compliance in the drug sensitivity evaluation (classification into one of two resistance categories: resistant/non-resistant) for 20 antibiotics.

Antibiotic resistance is one of the gravest global threats to public health. The problem of drug resistant pathogens occurring and spreading is mainly connected with the excessive use and misuse of antibiotics, but also with tourism, intensive trade and climate change. In response to those threats, the BacterOMIC system tests the effectiveness of 20 antibiotics at once: amoxicillin, cefuroxime, cefazolin, tobramycin, amikacin, azithromycin, ceftazidime/avibactam, ciprofloxacin, clindamycin, ceftriaxone, cefotaxime, cefepime, moxifloxacin, norfloxacin, ofloxacin, piperacillin/tazobactam, trimethoprim, trimethoprim/sulfamethoxazole Those antibiotics are used in the treatment of infections with the Enterobacterales; Pseudomonas; Acinetobacter, Staphylococcus bacteria, which are the source of e.g. urinary tract infection, dermatitis, respiratory tract infection and blood infection. The Company’s Management Board has informed that the number of antibiotics tested in the BacterOMIC diagnostic panel will be extended gradually.

-The completion of validation tests is a decisive step towards marketing the BacterOMIC system. We are glad that the result of a few years of our work will soon be released to the first users under the Early Access Program. We will continue to develop the panel by adding more antibiotics, in order to make the best possible use of the system. We believe that BacterOMIC will contribute to reducing the global problem of antibiotic-resistant bacteria infections, says Marcin Izydorzak, co-founder, key shareholder and Vice-President of the Management Board of Scope Fluidics.

The results of the test completed so far already constitute grounds for filing an application with the Director General of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) for registration of the BacterOMIC system as a medical device for in vitro diagnostics. The application will be submitted immediately after the necessary documentation is prepared. If the URPL Director does not refuse within 14 days, the BacterOMIC system will be CE-IVD certified, which means it can be launched on the European Union’s market.

Last week, the Management  Board of Scope Fluidics announced a year-long operation plan that includes, among other things, further development of the BacterOMIC panel as well as preparation of the system for mass production and introduction into the medical diagnostics market. Building the recognition for the BacterOMIC system is a part of the Scope Fluidics’ business model based on the development and sales of the technology to a global entity operating in the medical diagnostics market.

Thanks to the CE-IVD certification, the system can be tested in diagnostic facilities under the Early Access Program, and thus additional information can be obtained about the system’s functionality usefulness, ease of operation and efficiency. The data acquired in this way will also be used in the optimization of the maintenance program. Moreover, some information from the tests will be included in the analysis of the legitimacy of developing the BacterOMIC system’s panel portfolio.

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Scope Fluidics: BacterOMIC system for identifying antibiotic resistance has obtained the European CE IVD marking approval