Scope Fluidics – a biotechnological company listed on NewConnect, owner of innovative projects in the field of medical diagnostics – has completed a series of works aimed at optimizing of the PCR|ONE system analyzer and begun clinical certification tests of the Staphylococcus aureus (MRSA/SA) panel in an external hospital laboratory. The Company aims to finish testing as soon as possible and register the MRSA/SA panel of the PCR|ONE system as a medical device used in in-vitro diagnostics.
Since December 2020, the Curiosity Diagnostics team has worked on optimizing the solutions used in the PCR|ONE analyzer. The system has been tested regularly in clinical conditions between December 2020 and January 2021. The works resulted in the readiness to conduct a series of tests, the results of which will be presented in the registration dossier of the MRSA/SA panel. To accelerate the testing process, particularly concerning the collection of test samples, the Company has installed the PCR|ONE system in one more clinical center.
– In December and January, the Curiosity Diagnostics team has worked out a series of efficient solutions, which resulted in commencement of the certification testing process. We highly value our cooperation with the hospital laboratory where we tested the system. We are now beginning series of tests that are crucial to obtain the CE-IVD certification in the very same facility. At the same tame, we introduced the PCR|ONE system into another medical facility, which will also take part in the process, first during preparation and then in the certification testing, says Prof. Piotr Garstecki, co-founder, key shareholder and CEO of Scope Fluidics S.A.
Scope Fluidics expects that the clinical tests needed to obtain the CE-IVD certification will be finished in the first quarter of this year. A few days ago, the Company also announced the completion of a series of preclinical tests on the SARS-CoV-2 panel. With the newly optimized test protocol, the system has reached certain key clinical parameters. As is the case with the MRSA/SA panel, certification clinical trials are to be launched later this month. The Company intends to use the results of the SARS-CoV-2 panel certification tests in the documentation crucial to obtaining the European CE-IVD certification and American FDA EUA authorization under a special EUA authorization related to the pandemic situation.