Scope Fluidics, a life science company listed on the Warsaw Stock Exchange, has updated the development plan for the BACTEROMIC system for 2026–2027. The updated plan includes focusing R&D efforts on the UNI FAST and PBC panels, pursuing optimal certification pathways in the EU and the United States, building in-house production capacity, and preparing for the commercial launch of the system. The company expects to generate its first revenues in 2026.
The new development strategy for the BACTEROMIC system is intended to enhance its attractiveness to potential strategic partners.
“The past months have been extremely intense for us and, at the same time, very productive. We obtained the first CE-IVDR certificate for the BACTEROMIC system, which opens the way for us to introduce the system in markets that recognize CE-IVDR certification. The certification also confirms the maturity of the BACTEROMIC system in the eyes of potential business partners. Our team continuously analyzes market demand and the optimal development pathways for our products. We are focusing on solutions that address the growing demand from laboratories for fast and reliable results, which is why we treat the development of panels compatible with FAST software as a priority. At the same time, we are implementing our plan to build our own production capacity and beginning sales activities. We believe that this direction will allow us to efficiently complete the next key certification processes in Europe and the United States and successfully carry out commercialization,” said Piotr Garstecki, CEO of Scope Fluidics.
Key areas of the update
Scope Fluidics intends to continue R&D work on the following panels: UNI FAST, the extended UNI FAST panel (formerly Rapid UNI MAX), and PBC (formerly Rapid PBC). The UNI FAST panel is being developed in two versions. For IVDR certification, expected in mid-2026, the company plans to submit a panel based on the UNI panel. However, the final number of antibiotics and antibiotic–bacteria combinations included in the certification process may be lower than in the UNI panel. For FDA certification, Bacteromic plans to apply with the extended version of the panel, which will include up to 52 antibiotics. The final number of antibiotics will be determined as R&D work progresses.
FDA certification for the extended version of the UNI FAST panel (i.e., up to 52 antibiotics) is planned for mid-2027. In the same year, IVDR certification for the extended UNI FAST panel is also expected. It should be noted that both the number and the portfolio of antibiotics included in the extended UNI FAST panel may differ between the respective certification processes.
Taking into account that obtaining a sufficient number of samples for the clinical studies (performance evaluation) required in the certification process for the PBC panel may take more time, CE-IVDR certification is expected to be obtained by the end of 2027. The decision to conduct clinical studies and submit an application for FDA certification for the PBC panel will be made at a later stage.
The production line for BACTEROMIC system panels – whose readiness is planned for the beginning of the second half of 2026 – will consist of machines that have already been purchased by Bacteromic in connection with an earlier plan to build a production line in Spain with a capacity of up to 750,000 panels per year. Bacteromic intends for the line to reach up to half of its capacity by the above-mentioned date and then achieve full planned capacity within the following several months.
Production of devices (i.e., analyzers and filling machines) is carried out in cooperation with BIT Analytical Solutions. The Bacteromic team intends to continue cooperation with BIT AS while also analyzing the possibility of establishing cooperation with other entities.
The Bacteromic team will continue activities related to the commercial launch of the BACTEROMIC system. Decisions regarding the selection of specific markets or regions and the order in which the BACTEROMIC system will be introduced will be made as sales activities progress. The first revenues from sales of the BACTEROMIC system are expected in 2026. The Bacteromic team is cooperating with distributors on market strategies to estimate sales potential and adapt to the changing market environment, pricing policies, and public procurement rules.
The implementation of the planned objectives for 2026–2027 should not require raising additional financing. At the same time, with the adoption of the updated objectives, the Management Board has decided to discontinue activities aimed at signing financing agreements with the European Investment Bank for the BACTEROMIC project in the amount of up to EUR 15 million.