Subsidiary of Scope Fluidics receives a positive recommendation regarding ISO 13485:2016 compliance certification


grafikaCuriosity Diagnostics, owned by Scope Fluidics – a biotechnological company listed on NewConnect, owner of innovative medical diagnostics projects – has successfully passed an ISO 13485 certification audit, which proved that it meets the requirements set out in the standard. Thus, one of the milestones for registration and certification of the PCR|ONE system.

The company has completed the ISO 13485:2016 certification, dedicated to the Quality Management System for Medical Devices to prove it meets international standards. The audit was conducted by the Polish Centre for Testing and Certification. The leading auditor informed Curiosity Diagnostics that a positive recommendation has been issued for the certification of the quality management system in accordance with ISO 13485:2016 in the scope of: design, production and distribution of systems for in vitro molecular diagnosis (IVD) used to diagnose and monitor the presence of pathogens in tested samples. The certification is aimed at guaranteeing safety and high quality of products, as well as confirmation of compliance with legal requirements.

Meeting the ISO requirements set out in international standards for medical devices is a necessary condition to join the group of trusted manufacturers in this field. We are glad that we have passed the audit and soon we will receive a certificate confirming the implementation of quality management systems in our company. A positive audit is a requirement without which we could not register the PCR|ONE system, says Marcin Izydorzak, co-founder, key shareholder and Member of the Board of Scope Fluidics S.A.

The implementation of a quality management system in an organization that has been developed based on creativity is neither easy nor obvious. It has been a huge effort for our team and it represents a huge step on our way to registering our diagnostic systems. Passing the ISO 13485 audit demonstrates that the PCR|ONE system is reaching commercial maturity. It is a very meticulously verified confirmation that we have moved from the invention stage to the production of a system for medical diagnostics. Further projects within the Scope Fluidics group will benefit significantly from this process. As far as the PCR|ONE system is concerned, we have one final step ahead of us on the road to CE-IVD certification, namely clinical trials, which we hope to carry out as soon as possible in a post-pandemic reality.”adds Piotr Garstecki, co-founder, key shareholder and CEO of Scope Fluidics S.A.

Recently, the Company was granted a patent which protects the technology applied in the PCR|ONE system. With this technology, the PCR|ONE analyzer is capable of performing an ultra-fast polymerase chain reaction (PCR) on multiple samples simultaneously. The company has previously obtained patents for its invention in the United States and Europe. In total, Curiosity Diagnostics holds 46 patents, including 27 patents protecting key technologies for the PCR|ONE system.

Patents securing technology in global markets and quality management system certificates that confirm the compliance with international requirements will be an important element in protecting the commercialization process of the system.

The PCR|ONE system addresses the global need for rapid and informative molecular diagnostics. The device conducts fully automatic analysis of genetic material of bacterial and viral pathogens – it can identify up to several dozen pathogens within several minutes of sampling. The company will offer a few panels targeted at the most serious threats to human health. The first one, on which work is almost completed, is a panel detecting methicillin-resistant strains of Staphylococcus aureus (MRSA), which are a frequent cause of hospital-acquired infections demonstrating high antibiotic-resistance. In March, the Company decided to extend the work on the panel for the diagnosis of viral respiratory tract infections to include the development of an ultra-fast test for the detection of SARS-CoV-2 virus causing Covid-19. The development of an additional panel is expected to increase the business attractiveness of the PCR|ONE system for future buyers.