Scope Fluidics – a biotechnological company listed on NewConnect, owner of innovative projects in the field of medical diagnostics – has announced it has successfully completed preclinical trials of the SARS-Cov-2 virus panel. With optimized test protocols, the system has obtained high values of the key clinical parameters, i.e. 86% sensitivity and 100% specificity.
Since December, the Company has undertaken additional R&D works to improve the system. Last week, tests on 19 clinical samples marked the completion of these works. For 17 samples, reference results were obtained, achieving 86% sensitivity and 100% specificity. However, during trials the Company has encountered organizational challenges regarding the collecting of clinical samples.
Scope Fluids is aiming to extend the trials as soon as possible by increasing the number of medical facilities in order to obtain a sufficient number of samples for certification tests.
– The latest optimization steps related to the development of the PCR|ONE system in terms of ultra-fast detection of the SARS-CoV-2 virus translated into successful test results. Later this month, we want to launch proper clinical trials for this panel. Meeting the end of March deadline for the certification tests will depend on the possibility of obtaining a sufficient number of samples for testing. We are working on increasing the number of medical facilities to accelerate the process of certification tests – says Prof. Piotr Garstecki, co-founder, key shareholder and CEO of Scope Fluidics S.A.
Based on the result obtained, later this month, the company is planning to begin the certification tests concerning SARS-Cov-2 virus panel in the PCR|ONE system. The results of the tests will be used in the documentation that is crucial to obtain the European CE-IVD certification and American FDA EUA authorization. The Company has informed that the challenges related to the collection of clinical samples might influence prompt certification of the PCR|ONE system.