Scope Fluidics’ Microfluidic Antimicrobial Susceptibility System Obtains European CE IVD Marking Approval

Scope Fluidics’ (Warsaw, Poland) BacterOMIC microfluidic antimicrobial susceptibility system has received a European CE marking certificate for in vitro diagnostic devices, which approves it for use on the European Union market.

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 modern diagnostic device 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. 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. The company plans to expand the system with more antibiotics in order to make full use of the system’s diagnostic capabilities.

“BacterOMIC is a system with a very large market potential, which has a chance to revolutionize antibiotic treatment,” said Marcin Izydorzak, Vice President and one of the founders of Scope Fluidics. “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 USD1 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.”

“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,” added Dr. Seweryn Bajer-Borstyn, head of the BacterOMIC project in the Scope Fluidics Group. “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.”

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