Scope Fluidics, a life science company listed on the Warsaw Stock Exchange, is expanding its cooperation with an advisor in the process of obtaining FDA certification for the BACTEROMIC system with the UNI FAST Panel. The purpose of this expansion is to enable its subsidiary, Bacteromic, to apply for certification directly for the extended version of the panel, which will shorten the time needed to assess bacterial drug susceptibility to 8 hours, allow analysis of up to 52 antibiotics, and detect up to three resistance mechanisms. FDA certification is planned for the first half of 2027.
“Expanding cooperation with the advisor in the FDA certification process is the result of ongoing R&D efforts and operational preparations for clinical trials in the United States. The BACTEROMIC system with the UNI FAST Panel has the potential to provide the most comprehensive and rapid analysis of bacterial drug susceptibility – all to support physicians in making accurate therapeutic decisions. Certification in the U.S. of such a highly informative and fast panel increases the project’s value both in terms of a potential strategic acquisition of the BACTEROMIC system and from an operational perspective,” said Piotr Garstecki, CEO of Scope Fluidics.
Thanks to the expanded cooperation with the advisor in the FDA certification process for the BACTEROMIC system with the UNI FAST Panel, the Group’s subsidiary will be able to apply for certification directly for the version enabling susceptibility testing of bacteria against up to 52 antibiotics and detection of up to three resistance mechanisms: ESBL, MR, and HLGR. The UNI FAST Panel will operate with “fast detection” software, which will reduce the time required for bacterial susceptibility assessment from the current 16 hours to a maximum of 8 hours.
It should also be noted that both the panel and the software remain in the R&D phase, and the final number of antibiotics included in the FDA certification submission may be lower than the maximum currently under development. The expanded cooperation will also increase the costs of clinical and reproducibility studies by approximately USD 1.3 million – from the previously planned USD 2 million to USD 3.3 million. FDA certification for the BACTEROMIC system with the UNI FAST Panel is scheduled for the first half of 2027, earlier than in previous timelines.
