28.10.2021

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

The BacterOMIC system, developed by the Scope Fluidics Group, has received a European CE  marking certificate for in vitro diagnostic devices, which approves it for use on the European Union market. A modern diagnostic device, developed by a team of Polish microbiologists and engineers has undergone clinical tests of the first diagnostic panel. The tests confirmed the functionality of the BacterOMIC system in diagnosing the drug susceptibility of bacteria causing a number of infections, including in the respiratory system, blood, urinary tract and skin. As emphasized by doctors and WHO experts[1], antibiotic resistance is one of the most serious problems in modern medicine.

During specialized tests carried out in independent clinical centers, the system achieved over 90% compliance in the drug susceptibility assessment for 20 antibiotics which were assigned to one of the two resistance categories: resistant/susceptible. in the process of further works, the management board plans to expand the system with more antibiotics in order to make full use of the system’s diagnostic capabilities. Soon, BacterOMIC will be made available to the first users as part of the Early Access program. The opinions and experiences obtained from new users will allow for the improvement of the system, its usability and efficiency of operation in the target work environment.

BacterOMIC is a system with a very large market potential, which has a chance to revolutionize antibiotic treatment. Today, the needs of doctors and their patients in this area are enormous. Experts estimate that the market for automated antimicrobial susceptibility testing is worth approximately $ 1 billion annually. Clinical tests have proven the efficiency of the BacterOMIC system, which ultimately might be able to test all clinically significant antibiotics in one test, says Marcin Izydorzak, Vice President and one of the founders of Scope Fluidics.

The CE (Conformite Europenne) marking obtained for the BacterOMIC system is a legal requirement to introduce the system to the market in the European Union, which confirms compliance with the EU standards as well as the European directives for medical devices. According to the annual action plan announced by the Scope Fluidics Management Board at the end of September 2021, in the next stages the system will be prepared for mass production and launching on the medical diagnostics market.

BacterOMIC is an exceptional solution on a world scale, and ultimately it is intended to allow us to check up to 640 bacteria cultivation conditions in one test. This will translate into the possibility of creating a single test to cover most clinically used antibiotics. We are happy that our work on all the aspects of the system were confirmed in the clinical tests of the first BacterOMIC diagnostic panel, emphasizes Dr Seweryn Bajer-Borstyn, head of the BacterOMIC project in the Scope Fluidics Group.

The BacterOMIC system allows for the identification in a single test of the effectiveness of a range of 20 antibiotics that are used in the treatment of, among others, infections of the respiratory tract, blood, urinary tract, or skin, caused by the Enterobacterales; Pseudomonas; Acinetobacter, Staphylococcus bacteria. The system makes it possible to assess the treatment effectiveness for the following antibiotics, all in one test: amoxicillin, cefuroxime, cefazolin, tobramycin, amikacin, azithromycin, ceftazidime, ceftazidime with avibactam, ciprofloxacin, clindamycin, ceftriaxone, cefotaxime, cefepime, moxifloxacin, norfloxacin, ofloxacin, piperacillin, piperacillin with tazobactam, trimethoprim, trimethoprim with sulfamethoxazole.

The works on the system began in 2016. That is also when the general assumptions were specified,  which have been further developed by the Scope Fluidics team in the next stages. The subsequent generations of the system, with improved ergonomic features and solutions that facilitate industrialization, were tested in prestigious clinical centers, including the National Medicines Institute, National Tuberculosis and Lung Diseases Research Institute and Children’s Memorial Health Institute. In 2021, the company launched a production line for the assembly of diagnostic cartridges and devices, patented the developed technology, and received the quality certificates compliant  with ISO13485.

In October 2019, BacterOMIC received prestigious European Commission support through the SME Instrument Phase 2, part of the Horizon 2020 programme, for their “Intelligence for precision therapies against antimicrobial resistance: The first diagnostic panel that probes all the clinically relevant antibiotics at once” project.

 

More information on the problem of drug resistance can be found at:

https://www.amr-insights.eu/

https://www.who.int/health-topics/antimicrobial-resistance

https://www.cdc.gov/drugresistance/index.html

http://antybiotyki.edu.pl/edwa/zobacz-odp-stosowanie-pacjent.php

 

[1] https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance