Scope Fluidics S.A. (WSE: SCP) – a biotech company listed on the sWIG80 index and renowned for completing the largest life science transaction in Polish market history in 2022, has released operational targets (“Targets”) for the BacterOMIC project, set to be concluded by mid-2024.
Professor Piotr Garstecki, co-founder, major shareholder and CEO of Scope Fluidics: “In parallel with the development of the BacterOMIC technology, we are actively engaging with the scientific, clinical, and business communities. We have crafted a comprehensive roadmap that specifically addresses critical clinical needs while meeting the expectations of potential technology buyers. Our overarching aim remains to maximize the value of the BacterOMIC system.”
Gajane Zurawska, Global Business Development Director Scope Fluidics: “Our observations highlight a notable lack of awareness regarding innovative diagnostic methods for drug resistance and their transformative potential, even in highly developed markets. Simultaneously, we witness an increasing demand for the advancement of such technologies, recognizing how critical microbial drug resistance is today and witnessing a shifting market perspective. From our point of view, this is very good news. BacterOMIC already possesses numerous distinctive features that give it a competitive advantage over existing solutions, while also exhibiting enormous potential for further development.”
Scope Fluidics has set three operational objectives related to the development of BacterOMIC technology:
Objective I: Initiate testing of the BacterOMIC system under the Early Access Programme (“PEA”)
In pursuit of the Objective, the Company plans to establish cooperation with centres that are potential end-users of the BacterOMIC system (clinical laboratory, hospital laboratory or private centre). The activities will be carried out in cooperation with a distributor (or distributors) who will establish cooperation with end users of the BacterOMIC system. The proposed action model involves the distributor leasing analyzers and subsequently transferring them to end users. Additionally, the distributor will purchase panels from the company for resale to the mentioned users. However, the company remains open to exploring alternative cooperation models in the future. The company aims to gradually expand the number of external centers participating in the Early Access Program (PEA).
Achieving the objective will require the establishment of an internal pilot production, including the launch and validation of an internal laboratory and pilot production space in accordance with ISO standards. Additionally, it involves optimizing the cost and logistics of manufacturing and product storage.
Target I should be achieved by the end of 2023.
Objective II: Commence commercial production of the BacterOMIC system
Scope Fluidics plans to produce and market the initial series of panels and devices, with the ultimate goal of commencing sales of the BacterOMIC system to end users. The company remains open to initiating sales by utilizing the internal production capacity established for the Early Access Program (PEA).
Target II is expected to be achieved in the first half of 2024.
Objective III: Expand product and patent portfolio
Objective I and Objective II will be carried out using the current version of the panel, which allows phenotypic assessment of the efficacy of 25 antibiotics and has the ability to detect the ESBL resistance mechanism (presence – extended spectrum lactamases) based on three independent assays. In parallel to the activities undertaken under Objective I and Objective II, development work will be carried out to expand the product and patent portfolio. Development work will be preceded by an analysis of PEA results and market preference analysis.
The company plans to expand its product portfolio, which may include panels for new areas, as well as adding additional antibiotics or combinations of antibiotics to the drug resistance testing panel.
Preparatory work for certification in Europe (IVDR) and the United States (FDA) will be carried out to assess the readiness of the BacterOMIC project to receive certification in accordance with the IVDR and FDA and to decide on the choice of regulatory pathway and strategy to achieve regulatory compliance of the system. Certification in at least one of the mentioned areas is anticipated, while the company does not rule out the possibility of certifying the current version of the system in the United States as well.
The company will continue to develop its patent portfolio – both for current solutions and for technologies yet to be developed as part of its product portfolio development work.
Between 2023 and 2024, the company intends to initiate regional and national phases for the two BacterOMIC project inventions covered by international applications. This involves filing patent applications directly with patent offices in the most promising markets, including at least securing intellectual property related to the BacterOMIC system in the USA and Europe).