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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 2021-02-26 Director's Dealing
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
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 (389 characters) and explicitly states that a notification ('zawiadomienie') received under Article 19(1) of MAR Regulation concerning a transaction by a person closely associated with a management function (the Chairman of the Supervisory Board) is attached as an appendix to the current report. This structure—a brief announcement stating that a specific regulatory notification is attached—strongly indicates a Report Publication Announcement (RPA) or a general Regulatory Filing (RNS). Since Article 19 MAR notifications relate to insider transactions by management/directors, the most specific category related to insider trading is Director's Dealing (DIRS). However, the document itself is not the actual transaction report (which would be the MAR notification); it is the announcement *about* receiving that notification. Given the brevity and the nature of announcing an attached regulatory document, RPA is a strong candidate. However, since the content is specifically about a transaction by a director/insider, and the MAR notification itself is the core subject, DIRS is often used for the underlying event. Given the 'MENU VS MEAL' rule, where a short announcement of an attached document points to RPA, I will prioritize RPA as the document is announcing the publication/receipt of the underlying filing. If DIRS was used for the actual MAR filing, RPA is used for the announcement of that filing. I will select RPA as the primary classification for the announcement itself.
2021-02-26 Polish
Aktualizacja informacji na temat działań w kierunku oceny skuteczności klinicznej systemu PCR|ONE - Content (PL)
Regulatory Filings Classification · 1% confidence The document is a formal notification from the Management Board ('Zarząd') of Scope Fluidics S.A. regarding ongoing clinical verification work on their PCR|ONE SARS-CoV-2 test. It details issues encountered with reference samples (cross-contamination risk) and the subsequent decision to change the reference methodology to a Point-of-Care method. This change necessitates new clinical trials and results in a delay in the expected completion date. This type of communication, detailing operational issues, changes in testing protocols that impact timelines, and updates on regulatory/clinical progress, fits best under 'Legal Proceedings Report' (LTR) if it involves regulatory scrutiny or significant operational hurdles that affect the business outlook, or potentially 'Regulatory Filings' (RNS) as a general material event disclosure. Given the focus on testing failures, methodological changes, and resulting delays in clinical trials, it is a significant operational/legal/regulatory update. Since it is not a standard financial report (10-K, IR, ER) or a management discussion (MDA), and it relates to the status of product validation which often has regulatory implications, 'LTR' (Legal Proceedings Report, often used broadly for significant adverse operational/regulatory events) or 'RNS' (Regulatory Filings) are the closest fits. As it is a specific update on a material event concerning product validation and delays, and not a general announcement of a report being published (RPA), 'RNS' is the most appropriate general regulatory disclosure category for material, non-standard updates in this context, especially since the text is detailed and not just a brief announcement.
2021-02-25 Polish
Rozpoczęcie certyfikacyjnych testów klinicznych na panel MRSA/SA - Content (PL)
Regulatory Filings Classification · 1% confidence The document discusses the initiation of certification clinical trials for a diagnostic panel (MRSA/SA) which will be used for European CE-IVD certification documentation. It mentions optimization work on an analyzer, installation of the PCR|ONE system in a second clinical center, and the goal to complete trials by the end of March. The final paragraph explicitly states that after the clinical trials are complete and a 'stosownego raportu' (appropriate report) is prepared, the company will register the system as an in vitro diagnostic medical device with the relevant regulatory body (Prezes Urzędu Rejestracji Produktów Leczniczych, wyrobów Medycznych i Produktów Biobójczych). This text is an update on ongoing regulatory/product development activities, specifically focusing on the clinical testing phase leading up to official registration. It is not a full financial report (10-K, IR), an earnings release (ER), or a management discussion (MDA). It details progress towards regulatory approval, which aligns best with a general regulatory update or a specific update on product certification/testing. Given the focus on clinical trials and subsequent regulatory submission for a medical device, it fits best under the general 'Regulatory Filings' (RNS) category as a specific operational update that doesn't match the other specialized codes (like LTR for legal proceedings or AR for audit reports). Since it is a substantive update on regulatory progress rather than just announcing a report, RNS is the most appropriate fallback.
2021-02-12 Polish
Zawiadomienie z art. 69 ustawy o ofercie publicznej od IPOPEMA Towarzystwo Funduszy Inwestycyjnych S.A.
Major Shareholding Notification Classification · 1% confidence The document is a formal notification dated February 8, 2021, referencing specific articles of the Polish Public Offering Act (Ustawa o ofercie publicznej) concerning changes in shareholding thresholds. It explicitly states that the total shareholding of funds managed by IPOPEMA Towarzystwo Funduszy Inwestycyjnych S.A. in Scope Fluidics SA has crossed the 25% threshold (moving from 24.88% to 26.05%). This type of mandatory disclosure regarding changes in significant share ownership is classified as a Major Shareholding Notification.
2021-02-08 Polish
Zawiadomienie o zmianie stanu posiadania akcji Spółki - Content (PL)
Major Shareholding Notification Classification · 1% confidence The document text is very short (410 characters) and appears to be a formal notification from the Management Board ('Zarząd') of Scope Fluidics S.A. It explicitly mentions receiving a notification ('zawiadomienie') from another entity (IPOPEMA TFI S.A.) regarding specific articles of Polish public offering law ('ustawy o ofercie publicznej...'). This structure—a company announcing receipt of a formal notice concerning share ownership or public offering regulations—is characteristic of a regulatory filing or a notification about a significant change in shareholding. Since the content details a notification received based on specific legal articles concerning public offerings and share structure, it strongly suggests a change in major shareholding or a mandatory regulatory disclosure. Given the options, 'Major Shareholding Notification' (MRQ) is the most fitting category for notifications related to changes in ownership thresholds or mandatory disclosures under public offering laws. If it were a general announcement without specific shareholding context, RNS would be used, but MRQ is more precise here.
2021-02-08 Polish
Wyniki testów przedrejestracyjnych panelu SARS-CoV-2 i perspektywa rozpoczęcia programu testów klinicznych - Content (PL)
Regulatory Filings Classification · 1% confidence The document is a formal announcement from the Management Board ('Zarząd') of Scope Fluidics S.A. written in Polish. It details the successful completion of external pre-registration tests for their SARS-CoV-2 panel, providing specific performance metrics (86% sensitivity, 100% specificity) from 19 tests conducted in December 2020 and January 2021. It also discusses future plans, specifically starting certification clinical tests in February for CE-IVD and FDA EUA approval, and mentions organizational challenges in sample collection that might cause delays. This content—reporting on operational progress, R&D results, and future regulatory steps—is characteristic of an ongoing business update or a report on specific operational developments, rather than a full financial report (10-K, IR) or a simple earnings release (ER). Since it is a detailed operational update concerning product development and regulatory progress, it fits best under the general category of Regulatory Filings (RNS) as a specific operational/regulatory update, or potentially a Legal/Regulatory update if the focus was on litigation, but here it is primarily operational progress. Given the lack of a specific category for R&D/Operational Progress Updates, and its nature as a formal, non-financial regulatory disclosure, RNS (Regulatory Filings) is the most appropriate fallback, although it contains elements similar to an MDA (Management Discussion/Analysis) if it were part of a larger report. Since it is a standalone, brief update on testing and regulatory path, RNS is chosen as the best fit among the provided options for a general, non-financial regulatory disclosure.
2021-02-08 Polish

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