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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 2021-04-16 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
Nadanie systemowi PCR|ONE panel MRSA/MSSA znaku CE-IVD - Content (PL)
Regulatory Filings Classification · 1% confidence The document is a formal announcement by the Management Board ('Zarząd') of Scope Fluidics S.A. It references a prior current report ('raport bieżący') and details significant operational and strategic developments, specifically the receipt of CE-IVD certification for a product panel (PCR|ONE panel MRSA/MSSA) and updates on ongoing discussions regarding the potential sale (M&A activity) of a subsidiary (Curiosity Diagnostics). This content relates to significant business events, strategic direction, and potential transactions, but it is not a standard periodic financial report (10-K, IR, ER) or a specific regulatory filing like a Director's Dealing or Dividend Notice. Since it discusses the process of finding a buyer for a subsidiary, it strongly relates to Merger & Acquisition (M&A) activity. The closest specific category is M&A Activity (TAR).
2021-04-16 Polish
Powiadomienie o transakcji, o którym mowa w art. 19 ust. 1 rozporządzenia MAR
Director's Dealing Classification · 1% confidence The document is titled "Powiadomienie o transakcji/transakcjach, o którym mowa w art. 19 ust. 1 rozporządzenia MAR" (Notification of a transaction(s) referred to in Article 19(1) of the MAR Regulation). Article 19 of the Market Abuse Regulation (MAR) specifically deals with notifications of transactions conducted by persons discharging managerial responsibilities (PDMRs) and persons closely associated with them. The content details a 'Zbycie' (Disposal) of shares ('Akcja') by an entity closely associated with a board member (ROBERT PRZYTUŁA - PRZEWODNICZĄCY RADY NADZORCZEJ) of Scope Fluidics S.A. This directly corresponds to the definition of Director's Dealing (insider trades by executives/directors). Therefore, the appropriate classification is DIRS.
2021-04-06 Polish
Otrzymanie zawiadomienia, o którym mowa w art. 19 ust. 1 MAR - Content (PL)
Director's Dealing Classification · 1% confidence The document text is very short (396 characters) and explicitly states that a notification ('zawiadomienie') received under Article 19(1) of the MAR Regulation concerning a transaction by a person closely associated with a management body member (the Chairman of the Supervisory Board) is attached ('stanowi załącznik do niniejszego raport'). This structure—a brief announcement stating that a required filing/notification is attached—strongly suggests a Report Publication Announcement (RPA) or a general Regulatory Filing (RNS), rather than the full content of the MAR notification itself. Since MAR notifications regarding insider transactions are a specific type of insider dealing report, and the text mentions a transaction by a person closely associated with management, the most fitting specific category is Director's Dealing (DIRS), as MAR Article 19 filings relate to insider transactions. However, given the 'MENU VS MEAL' rule, if this were the actual MAR form, it would be DIRS. Since this is an announcement *about* the filing being attached, RPA is plausible, but DIRS is the subject matter. Given the context of insider transactions being reported, DIRS is the most accurate subject classification, even if the format is an announcement wrapper. Let's re-evaluate based on the definitions. DIRS is for 'Report of personal share transactions by company directors and executives (insider trades)'. The text describes receiving such a report. If the text *was* the actual MAR form, it would be DIRS. Since it's an announcement that the MAR form is attached, RPA is technically correct by the 'MENU VS MEAL' rule. However, DIRS is a more specific subject classification than the general RPA/RNS fallback. Given the high specificity of the definitions, and the content being explicitly about an insider transaction notification (MAR Art. 19), I will classify it as DIRS, assuming the intent is to capture the subject matter, unless the text is purely boilerplate announcing the release of a major report like a 10-K. Since this is a specific regulatory notification (MAR Art. 19), DIRS is the best fit for the subject matter, overriding the general RPA rule for short announcements unless the announcement is about a major periodic report.
2021-04-06 Polish
Rozpoczęcie walidacji systemu BacterOMIC w zewnętrznym laboratorium - Content (PL)
Regulatory Filings Classification · 1% confidence The document text is a formal announcement from the Management Board ('Zarząd') of Scope Fluidics S.A. It references previous current reports ('raport bieżący') and details ongoing technical and regulatory processes related to the BacterOMIC system validation and verification, which are prerequisites for submitting documentation to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products ('Prezesa Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych') to obtain CE-IVD marking. This content describes specific operational updates, regulatory steps, and project timelines, rather than releasing periodic financial results (ER/IR), announcing management changes (MANG), or detailing insider trades (DIRS). It is a specific regulatory/operational update that doesn't fit the standard financial report categories (10-K, IR, AR). Given the nature of updating on regulatory progress and operational milestones, it most closely aligns with a general regulatory announcement or a specific operational update. Since it is not a standard financial report, dividend notice, or capital event, and it is a specific update on a product/regulatory path, the most appropriate general category for non-standard, specific corporate disclosures that aren't explicitly defined elsewhere is Regulatory Filings (RNS). However, because it details the progress of a specific project leading to regulatory submission, it is a type of operational/regulatory disclosure. Given the options, RNS serves as the best fit for a specific, non-financial, non-management, non-legal proceeding update that is mandatory disclosure.
2021-04-01 Polish
Zakończenie certyfikacyjnych badań klinicznych systemu PCR|ONE panel MRSA/MSSA - Content (PL)
Regulatory Filings Classification · 1% confidence The document is a current report (Raport Bieżący) from Scope Fluidics S.A. written in Polish. It details the successful completion of clinical trials for a diagnostic system (PCR|ONE panel MRSA/MSSA) and the subsequent issuance of a declaration of conformity, leading to the intention to register the medical device with the Polish regulatory body (URPL) to obtain the CE-IVD mark and commence sales in the EU. This announcement concerns the regulatory steps and results related to a medical product, specifically mentioning the finalization of a 'Raport Końcowy z badania' (Final Report from the study) and the subsequent regulatory filing process (zgłoszenia do Prezesa URPL). While it mentions a final report, the document itself is an announcement about the *results* of the study and the *next steps* in the regulatory approval process, not the full Audit Report (AR) or a general Regulatory Filing (RNS). Given the focus on the results of a specific study/test and the regulatory context surrounding medical devices, it most closely aligns with an announcement regarding a specific test result or regulatory milestone. However, none of the codes perfectly capture 'Medical Device Trial Results Announcement'. Since it details the results of a clinical study and the resulting regulatory compliance steps, it is closest to an Audit Report/Information (AR) if interpreted broadly as a report on testing/validation, or potentially a Regulatory Filing (RNS) as a general announcement. Given the specific mention of test results (sensitivity/specificity) and a final report being generated, 'AR' (Audit Report / Information - applied accounting principles, and results of internal or regulatory stress tests) is the closest fit among the provided options for reporting on the outcome of a formal validation/testing process, even though it's not a traditional financial audit. It is not an ER (Earnings Release) or IR (Interim Report). I will classify it as AR based on the reporting of formal test results and a final report conclusion.
2021-03-31 Polish
Rozpoczęcie przedrejestracyjnych testów klinicznych systemu PCR|ONE panel SARS-CoV-2 w nowym ośrodku klinicznym - Content (PL)
Regulatory Filings Classification · 1% confidence The document text is short (1067 characters) and discusses an update regarding clinical trials for a diagnostic system (PCR|ONE panel SARS-CoV-2) and the subsequent regulatory steps (CE-IVD certification via the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, and FDA EUA application). This is a specific operational/regulatory update that does not fit the definitions for a full Annual Report (10-K), Interim Report (IR), Earnings Release (ER), or a standard Director's Dealing (DIRS). Since it is an announcement about ongoing regulatory/product development progress, and it is not a standard financial report, it best fits the general 'Regulatory Filings' category as a miscellaneous regulatory/operational announcement, or potentially a Legal/Regulatory update (LTR), but LTR is usually for litigation. Given the context of product development and regulatory submission updates, RNS (Regulatory Filings - general fallback) is the most appropriate category for this type of specific, non-standard operational announcement.
2021-03-31 Polish

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