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

The BacterOMIC system, developed by the Scope Fluidics Group, received the European CE IVD certificate, which gives the legal possibility of admitting the system to trading 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 research confirmed the functionality of the BacterOMIC system in the diagnosis of drug susceptibility of bacteria causing a number of infections, incl. respiratory system, blood, urinary tract and skin.

“BacterOMIC is a system with a very large market potential, which has a chance to revolutionize the treatment with antibiotics. 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 trials have proven the efficiency of the BacterOMIC system, which can ultimately offer testing of even all clinically important antibiotics in one test” – says Marcin Izydorzak, vice president and one of the founders of Scope Fluidics.

The CE mark (Conformite Europenne), obtained for the BacterOMIC system, is a legal requirement to introduce the system to the market in the European Union and confirms compliance with EU standards as well as relevant 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 medical diagnostics on the market.

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