Scope Fluidics successfully completes validation of the extended BacterOMIC diagnostic panel and intends to launch the next phase of the Early Access Programme

30-05-2022

Scope Fluidics S.A., a specialist life science entity listed on the NewConnect market, which designs and develops innovative technological solutions for the medical diagnostics and healthcare markets, has completed validation tests of the optimized BacterOMIC UNI Panel. The tests confirmed the system’s ability to detect the presence of the ESBL-resistance mechanism on the basis of 3 independent assays and to determine the antimicrobial resistance of bacteria to 25 different antibiotics. A total of over 300 strains of Gram-positive and Gram-negative bacteria were analysed during the testing. Previously, the Company conducted validation tests for the SARS-CoV-2 and MRSA/MSSA diagnostic panels of the PCR|ONE system, which are adapted to scaled production. Now, Scope Fluidics intends to initiate the next phase of the Early Access Programme for its products.

The just-completed tests of the system confirmed compliance with the guidelines of as many as 28 determinations using the new, extended BacterOMIC UNI Panel. What is important, the study also confirmed the system’s ability to determine the mechanism of resistance and assess drug susceptibility of bacteria to 25 antibiotics, 9 of which were tested using the qualitative method (categories of resistance: susceptible or resistant), 9 using the quantitative method, i.e. by determining the minimum inhibitory concentration (MIC), while 7 antibiotics were tested using both the quantitative and qualitative method.  The 25 antibiotics tested included substances used to treat infections caused by the following bacteria groups: Enterobacterales, Acinetobacter, Pseudomonas, Staphylococcus and Enterococcus. These bacteria are responsible for a number of infections, ranging from minor urinary tract infections, through skin infections, to systemic infections. The BacterOMIC panel contains antibiotics that are tested for uncomplicated infections (e.g. ampicillin and a mixture of amoxicillin and clavulanic acid), but also for resistant bacteria (such as linezolid and tedizolid). Moreover, the system allows to detect the presence of enzymes that degrade penicillin-family antibiotics (extended-spectrum β-lactamases – ESBL), which are the most common cause of drug resistance of the Enterobacterales bacteria (which include Escherichia coli and Klebsiella pneumoniae). Detection of the presence of this resistance mechanism is clinically important for hospital-acquired infections and for out-of-hospital infections, especially including urinary tract infections. The ability of quantitative and qualitative assessment for certain classes of antibiotics will allow to make accurate therapeutic decisions

– The validation studies went very smoothly. We confirmed that the modified diagnostic panel also detects the ESBL-resistance mechanism, which is currently the main resistance mechanism of the Enterobacterales family Gram-negative bacteria, which includes the most common infection-causing species: Escherichia coli and Klebsiella pneumoniae. The presence of this mechanism makes them particularly resistant to treatment and thus dangerous to humans. Detection of this resistance mechanism is clinically important for nosocomial infections and for out-of-hospital infections, especially urinary tract infections. The BacterOMIC UNI Panel is the first solution available on the market for drug susceptibility testing of both Gram-positive and Gram-negative bacteria in a single test, which facilitates diagnostic procedures – says Marcin Izydorzak, Vice-President of the Management Board of Scope Fluidics S.A.

The study was conducted following the completion of laboratory and engineering works thanks to which it was possible to improve the algorithm that evaluates microbial growth and to increase the reproducibility of the manufacturing process.

According to WHO, the increasing antimicrobial resistance (AMR) is now a major threat to global health, food security and economic development. As per the Global Research on Antimicrobial Resistance Report (The Lancet, data from 204 countries and regions), in 2019, AMR directly caused ca. 1.27 million deaths and indirectly contributed to another ca. 4.95 million fatalities. Researchers have pointed out that treatments based on broad-spectrum antibiotics are becoming ineffective and contribute to increased drug resistance.

– Traditional methods of testing the antibiotic susceptibility of bacterial strains (including the disk diffusion method), which have been used since the 1970s, are labour-intensive, time-consuming and lack precision. They are based on manual measurement of the inhibition zone, and in the case of a large number of antibiotics they are expensive. The BacterOMIC system developed by us is taking antibiotic susceptibility testing (AST) to the next level by offering automated assessment of a wide range of clinically relevant antibiotics in a single test. This allows us to reduce lab costs while accelerating the time to diagnosis resulting in shorter hospital stays for patients and reduced risk of inappropriate treatmentsays Gajane Żurawska, Global Business Development Director at Scope Fluidics S.A.

 

PREPARATIONS FOR THE NEXT PHASE OF THE EARLY ACCESS PROGRAMME

Scope Fluidics has recently announced the successful completion of validation tests of the optimised PCR|ONE SARS-CoV-2 and MRSA/MSSA panels. All the activities and work undertaken by the Company and its SPVs, Curiosity Diagnostics sp. z o.o. and Bacteromic sp. z o.o. were aimed at advancing to the next stage of the Early Access Programme. To this end, it was also necessary to take action with regard to PCR|ONE and Bacteromic systems associated with the replacement as of 26 May 2022 of the hitherto applicable CE-IVDD marking certification with the CE-IVDR certification.

The success of the just-completed BacterOMIC UNI Panel study also means that we are ready to launch the next phase of the Early Access Programme (EAP) for up to three diagnostic panels, as in recent weeks we have successfully completed not only the tests of the expanded BacterOMIC UNI Panel, but also the clinical PCR|ONE trial for the SARS-CoV-2 and MRSA/MSSA panels. Thus, for the PCR|ONE system, we will be able to conduct EAP based on a complementary set of panels diagnosing viruses and bacteria, facilitating outreach to a wide range of target users. As for the BacterOMIC system, we have made an update and submitted the relevant documents to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. The project team is also working on achieving compliance with the IVDR requirements for the optimised analyser as soon as possible. We want all the three panels to be used in research centres to confirm their advantages before users and to be present in scientific publications – Marcin Izydorzak points out.

On 26 May 2022, the existing CE-IVD marking certification was replaced by the CE-IVDR one. Thanks to obtaining the CE-IVD mark for panels before 26 May 2022, it is now possible to place them on the EU market without the need to obtain the new certification until at least 25 May 2025 (depending on the type of panel). Failure to obtain the CE conformity marking according to Directive 98/79/EC before 26 May 2022 would mean that the panel would have to be certified according to the new rules, including with the involvement of a notified body. At the same time, analysers that were CE-IVD certified before 26 May 2022 and placed on the EU market before that date can stay on the market without meeting the additional certification requirements under the IVDR procedure for three more years. In contrast, for analysers that were not placed on the market before 26 May 2022, certification according to CE-IVDR does not require the involvement of a notified body.