Scope Fluidics – a biotechnological company listed on NewConnect, developer of innovative medical diagnostics projects – begins validation of the BacterOMIC system on clinical samples in a second external laboratory. At the beginning of June, the BacterOMIC project was granted a certificate of compliance with the ISO 13485:2016 standard by the Polish Centre for Testing and Certification („PCBC”).
– As previously stated, we are commencing a validation program in another external laboratory. Conducting trials in two independent facilities will allow us to thoroughly test the BacterOMIC system. Positive completion of the trials will be an important step towards the commercialization of the project – comments Szymon Ruta, Member of the Board and CFO of Scope Fluidics.
Clinical trials in the first laboratory have been underway since April this year. The company intends to conduct trials in a total of three facilities, of which at least two will be external. Completion of pre-registration trials is scheduled for Q3 2021, provided that the situation related to the Covid-19 pandemic remains stable and does not affect the operation of facilities where trials will be held.