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Scope Fluidics S.A. — Investor Relations & Filings

Ticker · SCP ISIN · PLSCPFL00018 LEI · 259400EUNFX4E2BEHU15 WAR Professional, scientific and technical activities
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Filings indexed 518 across all filing types
Latest filing 2022-04-28 Regulatory Filings
Country PL Poland
Listing WAR SCP

About Scope Fluidics S.A.

https://scopefluidics.com/

Scope Fluidics S.A. is a biotechnology company that develops innovative medical diagnostic solutions based on microfluidic technologies. The company's business model involves incubating projects within special-purpose vehicles (SPVs) with the goal of selling them to global strategic partners. Its primary project, developed by its subsidiary Bacteromic Sp. z o.o., is the BACTEROMIC system. This automated system provides rapid, comprehensive antimicrobial susceptibility testing (AST) to address the challenge of antibiotic resistance. Previously, the company developed the PCR|ONE system for rapid molecular diagnostics through its Curiosity Diagnostics SPV, which was acquired by Bio-Rad in 2022. The company focuses on creating fast, effective, and accessible diagnostic tools to improve healthcare outcomes.

Recent filings

Filing Released Lang Actions
Rozpoczęcie certyfikacyjnych badań klinicznych panelu MRSA/MSSA dostosowanego do produkcji skalowej - Content (PL)
Regulatory Filings Classification · 96% confidence The document is a formal announcement from the Management Board ('Zarząd') of Scope Fluidics S.A., referencing previous current reports ('raport bieżący'). It details operational progress, specifically the start of clinical trials for an optimized diagnostic panel (MRSA/MSSA) and updates on regulatory compliance (CE marking transition from CE-IVD to CE-IVDR). This type of communication, focusing on specific operational milestones, regulatory hurdles, and strategic updates that are not full financial results (ER/IR) or management changes (MANG), fits best under a general regulatory announcement or update. Since it is not a standard financial report, a proxy statement, or a director's dealing, and it provides specific, material operational news, it is classified as a general Regulatory Filing (RNS), which serves as the fallback for specific operational updates that don't fit other categories. The document length (2262 chars) is short, but it is providing substantive news rather than just announcing the publication of a larger report, thus avoiding the RPA classification.
2022-04-28 Polish
Zakończenie certyfikacyjnych badań klinicznych panelu SARS-CoV-2 dostosowanego do produkcji skalowej - Content (PL)
Regulatory Filings Classification · 99% confidence The document discusses the completion of clinical trials for a SARS-CoV-2 panel, the results (98% sensitivity and specificity), the preparation of a Final Report ('Raport Końcowy z badania'), and subsequent steps like obtaining CE-IVD marking and filing with the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL). This content relates to the performance evaluation and regulatory pathway of a medical diagnostic product, which falls under the scope of regulatory testing and reporting, but is not a full annual report (10-K), an earnings release (ER), or a general management discussion (MDA). Since it details the results of a specific test/study ('Raport Końcowy z badania') related to product validation, it aligns best with the 'Audit Report / Information' category, which covers applied accounting principles and results of internal or regulatory stress tests, extended here to cover significant product validation reports. Given the document length (2301 chars) and content detailing specific test results and regulatory next steps, it is the report/information itself, not just an announcement of a report (RPA/RNS).
2022-04-28 Polish
Rozpoczęcie walidacji systemu BacterOMIC z rozszerzonym panelem diagnostycznym - Content (PL)
Regulatory Filings Classification · 95% confidence The document is written in Polish and discusses ongoing activities related to the validation and registration of a diagnostic system called BacterOMIC. Key phrases include 'badania przedrejestracyjnych walidacji' (pre-registration validation studies), 'złożona do Prezesa Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych' (submitted to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products), and the goal of obtaining 'oznakowanie CE-IVD' (CE-IVD marking) for use as an in vitro diagnostic medical device. This content relates to regulatory compliance, product development milestones, and interactions with regulatory bodies concerning medical devices. It is not a full annual report (10-K), an earnings release (ER), or a standard dividend notice (DIV). It describes specific regulatory/product development steps rather than announcing the publication of a major report (RPA) or being a general regulatory filing (RNS). Given the focus on regulatory submission plans and compliance for a medical device, it fits best under 'Legal Proceedings Report' (LTR) if it were a lawsuit, but here it is about product approval/compliance. Since there is no specific code for 'Regulatory Approval Process Update' or 'Medical Device Compliance', and it details specific legal/regulatory steps towards compliance, it is closest to a Legal/Regulatory Update. However, looking at the definitions, 'LTR' is for 'Significant lawsuits, regulatory actions, or legal matters'. This is a proactive regulatory step, not a reaction to a lawsuit or action against the company. The closest fit among the provided options for a detailed update on regulatory compliance and product certification steps, which often involves legal frameworks, is LTR, or potentially RNS as a general regulatory announcement. Given the detailed nature of the regulatory path described (submission to URPL, CE-IVD marking), it is a specific regulatory update. Since LTR is defined as 'Legal Proceedings Report' and this is about product registration, RNS (General regulatory announcements and fallback) is the most appropriate general category if a more specific one like 'Regulatory Filing' existed. However, since the text details specific steps towards regulatory compliance and product launch requirements, and it is not a standard financial report, RNS is the best fit as a catch-all for specific, non-financial regulatory news. Revisiting the options: It is not M&A (TAR), Financing (CAP), or Management Change (MANG). It is a specific operational/regulatory update. RNS is the designated fallback for miscellaneous filings that don't fit elsewhere. I will classify it as RNS.
2022-04-08 Polish
Rozpoczęcie certyfikacyjnych badań klinicznych panelu SARS-CoV-2 dostosowanego do produkcji skalowej - Content (PL)
Regulatory Filings Classification · 100% confidence The document is a formal announcement from the Management Board ("Zarząd") of Scope Fluidics S.A. written in Polish. It details operational updates regarding its subsidiary, Curiosity Diagnostics, specifically mentioning the start of clinical trials for an optimized SARS-CoV-2 panel and the transition of regulatory requirements from CE-IVD to CE-IVDR. This type of communication, which updates the market on significant operational milestones, regulatory compliance efforts, and product development progress, is characteristic of a general regulatory filing or a specific business update. Since it is not a full financial report (10-K, IR), an earnings release (ER), a management discussion (MDA), or a specific transaction notice (DIV, POS, DIRS), it falls best under the general category for regulatory announcements that convey material, non-financial business information. Given the context of updating on regulatory compliance (CE marking) and product development milestones, 'Regulatory Filings' (RNS) serves as the most appropriate general category, as it is a formal, required disclosure that doesn't fit the more specific operational/financial codes. The document explicitly states, "Spółka będzie informowała osobnymi raportami bieżącymi o realizacji działań..." (The Company will inform in separate current reports about the implementation of the actions...), suggesting this is one such current report/disclosure.
2022-03-30 Polish
Informacja o warunkowej decyzji Europejskiego Urzędu Patentowego o przyznaniu patentu na rozwiązanie rozwijane w projekcie BacterOMIC - Content (PL)
Regulatory Filings Classification · 90% confidence The document is a formal announcement from the Management Board ('Zarząd') of Scope Fluidics S.A. regarding a conditional decision by the European Patent Office ('Europejski Urząd Patentowy') to grant a patent to its subsidiary, Bacteromic. The text details the subject of the patent ('Microfluidic chip'), the conditions for granting it (acceptance of text, payment of fees), and the implications (exclusivity for commercial use). This type of announcement, concerning intellectual property rights, legal/regulatory decisions affecting the company's core technology, and future commercial exclusivity, fits best under the category of Legal Proceedings Report (LTR) or potentially Regulatory Filings (RNS) if LTR is too narrow. Since it is a specific report on a legal/patent outcome rather than a general regulatory filing or a lawsuit update, LTR is a strong candidate. However, given the options, and that it is a specific, material announcement about a legal/IP development, it is a significant corporate event announcement. Since there is no specific 'Patent/IP Update' category, and it is not a general regulatory filing (RNS) or a management change (MANG), I will evaluate against LTR (Legal Proceedings Report) and RNS (Regulatory Filings). LTR usually implies litigation or regulatory action against the company. This is a positive patent grant announcement. Therefore, the most appropriate general category for a specific, material, non-financial announcement that doesn't fit elsewhere is the fallback, RNS, as it is a formal regulatory notification regarding IP status. Given the highly specific nature of the content (patent grant), and the lack of a better fit, RNS (Regulatory Filings / General Regulatory Announcements) is the safest classification, although it is a very specific type of announcement.
2022-02-04 Polish
Wykaz akcjonariuszy posiadających co najmniej 5% liczby głosów na NWZ w dniu 7 grudnia 2021 r.
AGM Information Classification · 99% confidence The document text is a table titled "Wykaz akcjonariuszy posiadających co najmniej 5% liczby głosów na NWZ Scope Fluidics S.A. w dniu 7 grudnia 2021 r." which translates to "List of shareholders holding at least 5% of the votes at the Extraordinary General Meeting (EGM) of Scope Fluidics S.A. on December 7, 2021." This document explicitly lists major shareholders and their voting percentages as of a specific date related to a general meeting. This content directly relates to the results or declaration of voting rights/shareholder structure related to a meeting. The most fitting category is Declaration of Voting Results & Voting Rights Announcements (DVA), as it details the voting power distribution among major shareholders following or in preparation for a vote.
2021-12-10 Polish

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