Scope Fluidics S.A., a specialist life science entity listed on the NewConnect market, which develops innovative technological solutions for the medical diagnostics and healthcare markets, has begun certification clinical trials for its SARS-CoV-2 panel that has been adapted to scaled-up production as part of the PCR|ONE project. The company has upgraded the existing panel and analyser parameters.
The SARS-CoV-2 panel is a diagnostic solution using the Company’s proprietary PCR|ONE technology, which is currently being developed by a team of the Company’s subsidiary: Curiosity Diagnostics. The panel’s first version, which obtained CE-IVD certification back in 2021, has attracted considerable interest. The product’s high potential and unique technological advantages have prompted Curiosity Diagnostics’ R&D team to introduce improvements with a view to making it even better suited to the needs of the diagnostic industry and fully compatible with mass production technology. As a result, the panel’s production process has been simplified, the cost of its components and production reduced, and its maximum lifetime extended. Also the analyser has been optimised and adapted to handle the changed panel. Those efforts have also successfully increased the durability of key components of the analyser, reduced its energy consumption and simplified its operation, which will bring tangible benefits in the form of lower overall costs of using the PCR|ONE system.
Placing a medical device on the European Union market requires affixing to it the CE mark. Legislation has recently been amended so that the previously applicable CE-IVD certification is set to be replaced by the CE-IVDR procedure from 26 May this year. Affixing the CE-IVD mark to the SARS-CoV-2 panel before 26 May 2022 will allow the panel to be marketed in the European Union without the need to obtain the new IVDR certification until 25 May 2025. Meanwhile, the Company is also working to ensure that the analyser meets both the IVD and IVDR compliance requirements, which will allow launching the analyser on the EU market.
– “In line with our plan, we have completed the stage of adapting the SARS-CoV-2 panel for scaled-up production. The parameters now obtained for the panel and analyser are even better suited to the needs of mass production processes. Now, we are beginning clinical trials with a view to obtaining CE-IVD certification for the scaled-up SARS-CoV-2 panel, which will allow us to introduce an optimised diagnostic solution into the EU market. On the one hand, this will be an important factor in the commercialisation of the entire PCR|ONE system, and on the other hand, it will allow us to run an Early Access Programme based on a product adjusted to the requirements of medium- and large-scale production and to reach a wide audience,” says Piotr Garstecki, President of the Management Board of Scope Fluidics S.A.
Clinical studies of the SARS-CoV-2 panel will be conducted at an external research centre on clinical samples taken from patients. The maximum ease of use, operator safety and speed allowing as many as 3 analyses per hour are all significant advantages of the PCR|ONE system over its competitors. The company is also working to expand the application of the SARS-CoV-2 panel to include the ability to recognise influenza A, B and RSV viruses, which cause infections of the upper respiratory tract.
The company also plans to certify under the CE-IVD procedure its MRSA/MSSA panel intended for rapid detection of Staphylococcus aureus bacteria. The certification will enable both products to be marketed in the European Union before 26 May 2022.
– “Receiving CE-IVD certification for SARS-CoV-2 and MRSA/MSSA panels will allow us to run an Early Access Programme based on a complementary set of virus and bacteria detection panels, making it easier to reach a wide range of target users. Our vision is to provide the market with products that address the need identified by physicians and improve the patient diagnostic process. Although individual countries are revoking restrictions, the state of the epidemic is still maintained. PCR|ONE is a system that nowadays – as we already know that the SARS-CoV-2 virus and its mutations are going to stay with us for longer – can work effectively in hospitals and outpatient clinics, as well as in high-traffic facilities such as airports, railway stations or sports venues,” explains Piotr Garstecki.
In its project portfolio, Scope Fluidics is also developing the QuattroVir panel intended for diagnosis of influenza A and B viruses and RSV virus. The certification of this panel is going to involve the new CE-IVDR mode.
PCR|ONE technology is being developed by the special purpose vehicle Curiosity Diagnostics sp. z o.o. According to Scope Fluidics S.A.’s business model, work on the project is carried out by a dedicated team of microbiology scientists and high-class engineers and technicians, which may ensure synergistic and uninterrupted R&D processes in the company’s own laboratory.