Scope Fluidics – a biotechnological company listed on NewConnect, developer of innovative medical diagnostics projects – has completed clinical trials for the SARS-CoV-2 panel. The tests were conducted in an external hospital laboratory, where the company completed a pre-registration testing program for the SARS-CoV-2 panel that included the Point-of-Care reference method.
– We are very pleased to announce that we have completed clinical trials of the SARS-Cov-2 panel. Their completion is a key step towards obtaining CE-IVD certification, which in turn is an important milestone in the commercialization of the project – comments Piotr Garstecki, CEO and one of the founders of Scope Fluidics.
The PCR|ONE system SARS-Cov-2 panel is an ultra-rapid diagnostic system designed to detect coronavirus infection. The Company has just completed clinical certification testing of this system. Based on the data obtained, a final report of the clinical trial has been drafted. The data presented therein confirm the effectiveness of the PCR|ONE system in the target diagnostic environment. The system obtained high values of key clinical parameters: 91.2% sensitivity and 100% specificity. At the same time, the PCR-ONE system correctly detected all samples collected from potentially infectious patients, i.e., those with the RT-PCR Ct values below 30. In this pool of samples, the PCR|ONE system SARS-CoV-2 panel obtained 100% sensitivity and 100% specificity.
After compiling the necessary documentation, Scope Fluidics’ subsidiary and SPV, Curiosity Diagnostics sp. z o.o., is going to submit the PCR|ONE panel SARS-CoV-2 system as an in vitro diagnostic medical device to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products for CE-IVD certification. If the President of UPRL has no objections within 14 days, the PCR|ONE panel SARS-CoV-2 system will be able to use the CE-IVD marking, which in turn will allow it to be marketed in the European Union.
Obtaining the CE-IVD certificate will confirm the effectiveness of the PCR|ONE system SARS-CoV-2 panel in detecting the SARS-CoV-2 virus and conclude an important stage in the development of the system. In its trading announcement, the Issuer’s Management Board also informs that work is underway to optimize the PCR|ONE system for mass production requirements. This responds to the needs of the market and entities interested in acquiring the PCR|ONE technology. The M&A transactions executed in 2021 in the medical diagnostics industry mainly included entities that started production and sales of SARS-CoV-2 virus detection systems in 2020.