A notified body has initiated an assessment of Bacteromic Sp. z o.o., a company within the Scope Fluidics Group that is developing the BACTEROMIC project, to undergo certification in accordance with IVDR regulations. The BACTEROMIC system is an innovative diagnostic device designed to assess microbial drug susceptibility. Scope Fluidics S.A. (WSE: SCP) is a leading life sciences company listed on the sWIG80 index of the Warsaw Stock Exchange. In 2022, it made history by executing the largest transaction ever recorded in Poland’s life sciences market.
Securing IVDR certification for BACTEROMIC system components is a key milestone toward the commercial introduction of the system to the international market. Complete IVDR certification for all system components is targeted for the second half of 2025. The IVDR certification of the UNI panel and the software (interpreter) will require the involvement of a notified body, while the certification of the analyzer and the filler will be carried out through self-declaration. The process begins with a preliminary review of documentation, during which the notified body will assess the company’s readiness for IVDR certification. Based on this assessment, the notified body will decide whether to proceed with the certification process.
“This will be our first certification process under IVDR requirements and our first collaboration with a notified body. In recent months, we have taken comprehensive steps to ensure Bacteromic is fully prepared for this process,” said Marcin Izydorzak, Vice President, co-founder, and significant shareholder of Scope Fluidics.
The UNI panel allows for the assessment of bacterial susceptibility to up to 31 antibiotics and the detection of the ESBL resistance mechanism. It is an extended version of the UNI 25 panel, which evaluates 25 antibiotics. The addition of more antibiotics to the panel is the result of efforts under the Early Access Program, particularly market research and R&D work conducted by the company.
Thanks to the strategic efforts of the Bacteromic R&D team, we are expanding the range of assays on the UNI Panel. Our R&D activities are guided by the needs of the market and end users. We closely listen to their feedback while developing the panel’s antibiotics, ensuring our tests provide the most informative results and effectively support optimal antibiotic therapy selection,” said Prof. Piotr Garstecki, President, co-founder, and major shareholder of Scope Fluidics.
