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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 510 across all filing types
Latest filing 2021-08-02 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
Podpisanie umowy dotyczącej budowania wartości rynkowej systemu BacterOMIC - Content (PL)
Regulatory Filings Classification · 1% confidence The document text is a short announcement (919 characters) written in Polish by the Management Board ('Zarząd') of Scope Fluidics S.A. It details a specific business agreement ('pilotażową umowę wytwarzania') signed by a controlled subsidiary (Bacteromic) with a supplier (Technicolor Polska). This concerns a development and manufacturing agreement for cartridges. Since this is a specific, material business event announcement that doesn't fit the definitions for Earnings Release (ER), Capital/Financing (CAP), Director's Dealing (DIRS), or Dividend (DIV), it falls best under the general category for regulatory announcements that are material business updates, which is Regulatory Filings (RNS). It is not a full report, presentation, or management discussion.
2021-08-02 Polish
Informacja dotycząca wniosku w ramach certyfikacji FDA EUA sytemu PCR|ONE panel SARS-CoV-2 - Content (PL)
Legal Proceedings Report Classification · 1% confidence The document is a formal announcement from the Management Board (Zarząd) of Scope Fluidics S.A. regarding a decision made by the US Food and Drug Administration (FDA). Specifically, it concerns the FDA's decision not to substantively review an Emergency Use Authorization (EUA) application for a SARS-CoV-2 diagnostic system submitted by a subsidiary (Curiosity Diagnostics). This type of communication details a significant legal/regulatory event impacting the company's operations or product pipeline. Since it reports on a specific legal/regulatory action (FDA decision regarding EUA), it fits best under the Legal Proceedings Report (LTR) category, which covers significant lawsuits or regulatory actions. It is not a general earnings release (ER), a full annual report (10-K), or a management discussion (MDA). Given the short length and the nature of reporting a specific regulatory outcome, LTR is the most precise fit among the specific categories.
2021-07-28 Polish
Nadanie systemowi PCR|ONE panel SARS-CoV-2 znaku CE-IVD - Content (PL)
Regulatory Filings Classification · 1% confidence The document text is a brief announcement (1278 characters) from the Management Board of Scope Fluidics S.A. regarding a subsidiary, Curiosity Diagnostics, obtaining the CE-IVD mark for its PCR|ONE SARS-CoV-2 panel. This certification grants the right to market the product in the EU and is framed as an important step in finding a buyer for the subsidiary. This content relates to business operations, regulatory milestones, and strategic positioning, but it is not a full financial report (10-K, IR), an earnings release (ER), or a management discussion (MDA). Since it is a specific, material business update that doesn't fit the other specific categories (like DIRS, DIV, CAP), it falls best under the general 'Regulatory Filings' category (RNS) as a significant, non-financial regulatory/operational announcement, or potentially LTR if viewed as a regulatory milestone, but RNS is the most appropriate general regulatory announcement fallback.
2021-07-27 Polish
Wykaz akcjonariuszy posiadających co najmniej 5% liczby głosów na ZWZ 30.06.2021
Major Shareholding Notification Classification · 1% confidence The document text is in Polish and lists the shareholders who held at least 5% of the votes at the Ordinary General Meeting ('Zwyczajnym Walnym Zgromadzeniu') held on June 30, 2021. It details the number of shares, votes, and the percentage of votes at the General Meeting (% głosów na WZ) and total votes (% głosów ogółem) for each major shareholder. This content directly relates to the results of a shareholder vote at a general meeting. Therefore, the most appropriate classification is Declaration of Voting Results & Voting Rights Announcements (DVA). The document is short and contains the results, not an announcement about the results, so RPA/RNS is less specific.
2021-07-05 Polish
Wykaz akcjonariuszy posiadających co najmniej 5% liczby głosów na Zwyczajnym Walnym Zgromadzeniu Spółki, które odbyło się w dniu 30 czerwca 2021 r. - Content (PL)
Declaration of Voting Results & Voting Rights Announcements Classification · 1% confidence The document text is very short (203 characters) and states that the Management Board of Scope Fluidics S.A. is enclosing a list of shareholders who held at least 5% of the votes at the Ordinary General Meeting (Zwyczajnym Walnym Zgromadzeniu) held on June 30, 2021. This content relates directly to the results or participants of a shareholder meeting. The most specific category for voting results from a general meeting is 'Declaration of Voting Results & Voting Rights Announcements' (DVA). Although it is a list of major shareholders related to the vote, DVA is the best fit for meeting-related voting outcomes/data, rather than a general regulatory filing (RNS) or a director's dealing (DIRS).
2021-07-05 Polish
Zakończenie certyfikacyjnych badań klinicznych systemu PCR|ONE panel SARS-CoV-2 - Content (PL)
Regulatory Filings Classification · 1% confidence The document discusses the completion of certification clinical trials for a diagnostic system (PCR|ONE panel SARS-CoV-2) and reports specific performance metrics (sensitivity and specificity) based on a final study report ('Raport Końcowy z badania'). It also mentions subsequent regulatory steps, such as obtaining the CE-IVD declaration and filing with the Polish regulatory body (URPL). This content relates directly to the performance evaluation and results of a medical device, which aligns closely with the description of an Audit Report / Information (AR), especially since it details the results of internal/regulatory stress tests or performance evaluations against a standard, rather than being a full annual report (10-K) or a general earnings release (ER). Given the focus on test results and compliance documentation, AR is the most appropriate fit among the specific options.
2021-06-29 Polish

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