Meanwhile, the Company has also commenced certification clinical trials for its enhanced MRSA/MSSA panel designed to detect methicillin-sensitive or resistant Staphylococcus aureus bacteria.
Both diagnostic panels, PCR|ONE SARS-CoV-2 and PCR|ONE MRSA/MSSA, are part of an innovative molecular diagnostic system offering fully automated diagnostics within minutes from sample administration to test result. The PCR|ONE project is conducted by Curiosity Diagnostics Sp. z o.o. – a 100% subsidiary of Scope Fluidics S.A. The clinical trials are part of the CE IVD certification process which allows introduction of products into the European market.
In the case of the SARS-CoV-2 panel adapted to scaled up production, the full pool of the tested samples showed a 98% sensitivity and 98% specificity in detection of the SARS-CoV-2 pathogen. According to the testing protocol for the enhanced SARS-CoV-2 panel, the results of the PCR|ONE system test were compared with the results of the COVID-19 Real Time Multiplex RT-PCR Kit reference method (manufacturer: Labsystems Diagnostics Oy, Finland) point-of-care RT-PCR, which is a standard laboratory diagnostic method based on isolation of RNA and its quantification in a real-time PCR reaction.
– After confirming the operation of the SARS-CoV-2 panel in 2021, our team spent the following months adapting our diagnostic system to meet requirements of scaled-up production. Changes were made to the analyser, the structure and the components of cartridge and panel production. As a result, certification for these improved system components became required. In the certification clinical trial of the modified panel, we achieved a nearly one hundred per cent sensitivity in detecting SARS-CoV2 in sick people, and a nearly 100% specificity – that is, the ability to confirm the absence of infection in healthy people – says Piotr Garstecki, President of the Management Board of Scope Fluidics S.A.
The Company has also completed the optimisation phase of work for the MRSA/MSSA diagnostic panel and proceeded with its certification clinical trials. As in the case of the SARS-CoV-2 panel, optimisation of the MRSA/MSSA panel (including the cartridge) was conducted to better adapt the system to medium- and large-scale production. As part of these activities, the panel production process was simplified, the costs of system components and their production processes were reduced, and the maximum shelf life of the panel was extended. The scope of the work means that it is necessary to carry out certification of the optimised MRSA/MSSA panel.
Rapid and reliable detecting of Methycilin-Resistant Staphylococcus Aureus (MRSA) strains is particularly important for healthcare facilities such as hospitals and in such places as prisons, day care centres, and military facilities. According to analysts of the MRSA testing market it is forecast to grow by USD 518.33 million at a CAGR of 12% during 2021-2025 (Source: Technavio).
– Staphylococcus aureus is a bacterium which is quite common in more or less dangerous forms, which is why medicine has been fighting it for years, and effectively since the invention of antibiotics. Unfortunately, a side effect of this fight is the evolution of deadly strains of staphylococcus that are resistant to popular antibiotics. People usually associate MRSA infections mainly with hospital stays, but their occurrence is constantly rising and the number of out-of-hospital infections has been rising for many years, which only increases the need for rapid, accessible and accurate diagnostics. A year earlier, we had already confirmed the effectiveness of the first version of the MRSA/MSSA panel developed by our team. With a view to potential future production, we decided to introduce improvements which will allow us to be even more competitive on the market – says Piotr Garstecki, President of the Management Board of Scope Fluidics S.A.
The first version of the MRSA/MSSA panel was successfully clinically tested and received CE IVD certification in 2021. The system achieved high values for key clinical parameters in quantification of Staphylococcus aureus and its drug-resistant variant. In reference to the drug-susceptible form of Staphylococcus aureus, a 97% sensitivity and a 97% specificity were achieved, while for the drug-resistant variant of the bacterium, a 95% sensitivity and a 100% specificity were achieved respectively.
CE IVD CERTIFICATION AS A STEPPINGSTONE TO EARLY ACCESS PROGRAMME
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 both the SARS-CoV-2 and MRSA/MSSA panels of the PCR|ONE system before 26 May 2022 will allow them to be marketed in the European Union without the need to receive the new CE-IVDR certification for several years to come. In the case of the SARS-CoV-2 panel, documentation will be prepared for Curiosity Diagnostics Sp. z o.o. to issue a declaration of conformity of this panel with the essential requirements of the relevant European Union directives (CE-IVD marking). Next, an application will be made to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) to register the SARS-CoV-2 panel as a medical device for in vitro diagnostics. At the same time, the Company continues its efforts to ensure that the PCR|ONE analyser meets the requirements for compliance with both IVD and IVDR, which will make it possible to launch the analyser on the EU market also after 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. Activities are also continuing concerning preparation for the Early Access Programme, including the pilot production validation process, development of medium-scale production technology and preparatory activities for large-scale production.
– Our priority is to run an Early Access programme as soon as possible using both optimised panels adapted to scaled-up production. This ambitious plan will consist of placing our system in its final place of use – at hospitals and laboratories of our research partners. Such a model of marketing such an innovative medical device as our PCR|ONE system is an opportunity to confirm its efficiency, speed and any competitive advantages in the eyes of target users and opinion leaders. At the same time, with the Early Access programme we will receive coverage of our solutions in scientific publications, which will primarily be factual documentation of our advantages and unique features of the system,” says Piotr Garstecki.
As part of the PCR|ONE system, Scope Fluidics S.A. is also developing the QuattroVir panel intended for diagnosis of SARS-CoV-2 and influenza A and B viruses and RSV virus. Certification of this panel is going to involve the CE-IVDR mode.
The 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.