Scope Fluidics extends the functionality of the BacterOMIC system diagnostic panel and begins its validation study

bacteromic guide

Scope Fluidics S.A., a specialist life science entity listed on the NewConnect market which develops innovative technological solutions for the medical diagnostics and healthcare markets, has announced commencement of pre-registration tests of the expanded diagnostic panel of the BacterOMIC system. The aim of the tests is to validate and confirm the effectiveness of both qualitative and quantitative drug susceptibility assessment of the system’s diagnostic panel for an expanded pool of antibiotics to be tested by this system. The tests are set to involve cartridges produced in cooperation with Technicolor Polska.

The tests will be conducted at the Company’s internal laboratory using clinical material obtained from hospitals cooperating with the Scope Fludics Group. The validation tests of the first version of the diagnostic panel conducted in October 2021 allowed the BacterOMIC system to receive the CE-IVD mark. At that time, more than 900 bacterial strains were analysed and a more than 90% effectiveness of the qualitative classification of drug resistance made with the BacterOMIC system was confirmed for 20 antibiotics. In recent months, the BacterOMIC team has made a number of changes to the production process, system and procedures, and expanded this pool to include more antibiotics. The aim of the tests that have just begun is to confirm the same high performance of the panel, in relation to the reference method, in terms of quantifying drug susceptibility. This means that the system will not only select the antibiotic or a combination of antibiotics in the presence of which the growth of isolated microorganisms is inhibited, but also indicate the level of minimum inhibitory concentration (MIC) of the antibiotic. That is to be aided by an expanded algorithm for assessing microbial growth within the analyser and a modified diagnostic panel, including a cartridge manufactured in an optimised process in collaboration with Technicolor Polska.

– We are beginning pre-registration validation tests of an expanded version of our BacterOMIC system diagnostic panel. In autumn 2021, we conducted the first validation tests of the system, and in early 2022 we obtained patent protection for our microfluidic chip, and now we can further develop this product and build its commercial value. Our team conducted laboratory and engineering works on the diagnostic panel and improved the diagnostic algorithm that is part of the analyser. This work has resulted in expanding the informative value of the method by quantitative assessment of drug susceptibility for an increasing pool of antibiotics. We have already modified the cartridge, which is a component of the diagnostic panel, with a view to scaled-up production. We announced these activities last year and are implementing them according to plan. The idea of BacterOMIC was born several years after our first flagship PCR|ONE project. Despite the fact that the systems operate on completely different bases and are implemented by two separate research teams, with the experience gained in the work on PCR|ONE, we were able to develop the BacterOMIC project very dynamically. Our intention is to start the Early Access programme for the BacterOMIC system as soon as possible – says Marcin Izydorzak, Vice-President of the Management Board of Scope Fluidics S.A.

After completion of the tests, the Company will prepare documentation which it will then submit to the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in order to register the extended BacterOMIC diagnostic panel as a medical device for in vitro diagnostics. At the same time, the team working on the development of BacterOMIC is preparing the system’s analyser to meet the compliance requirements not only of CE-IVD but also of the new CE-IVDR certification.

– The results of the tests will be used to develop and submit to the Polish Food and Drug Administration (URPL) the required documentation in order to register the extended diagnostic panel as a medical device intended for in vitro diagnostics. At the same time, the team at our subsidiary company Bacteromic sp. z o.o. will issue a declaration of conformity stating the compliance of the Bacteromic system with the essential requirements of the relevant European Union directives awarding the optimised system the CE-IVD mark. Obtaining the CE-IVD mark before 26 May 2022 will allow the enhanced diagnostic panel to be marketed in the European Union without the need to obtain new IVDR certification. Meanwhile, the Company is also working to ensure that the analyser meets both the IVD and IVDR compliance requirements, which will allow launching the analyser on the EU market also after 26 May 2022 – explains Marcin Izydorzak.

The BacterOMIC system is the Company’s second strategic project after PCR|ONE. It is being developed within the special purpose vehicle Bacteromic sp. z o.o. According to Scope Fluidics S.A.’s business model, work on the project is carried out by a dedicated team of microbiology scientists and high-class engineers and technicians, which may ensure synergistic and uninterrupted R&D processes in the company’s own laboratory.