Scope Fluidics begins preparations for the accelerated registration procedure of the PCR|ONE SARS-CoV-2 panel in the USA


grafikaCuriosity Diagnostics, owned by Scope Fluidics – a biotechnological company listed on NewConnect, owner of innovative medical diagnostics projects, signed an agreement with Prof. dr hab. Krzysztof Pyrc, PhD, with the participation of the Laboratory of Virology of the Malopolska Centre of Biotechnology of the Jagiellonian University in Krakow, in order to assess the clinical effectiveness of the PCR|ONE system SARS-CoV-2 panel under the FDA Emergency Use Authorisation procedure.

Emergency Use Authorization (EUA) is a fast-track procedure for the authorisation of medical devices on the U.S. market conducted by the Food and Drug Administration (FDA), applied in emergency situations involving widespread public health threats. The authorization may apply to e.g. diagnostic methods for which there are no equivalents approved in a „regular” procedure or they are not available, and these methods may be important in addressing the public health threat that has occurred.

As announced, we are beginning preparations for the PCR|ONE system SARS-CoV-2 panel approval process in the USA. The research procedure conducted in the Jagiellonian University centre will be consistent with the FDA guidelines for clinical outcome assessment. Professor Krzysztof Pyrć is a recognized scientific authority in the field of coronavirus biology, and the Malopolska Centre of Biotechnology of the Jagiellonian University offers high class laboratories, with the Laboratory of Virology being a BSL3 safety class facility explains Prof. Piotr Garstecki, co-founder, key shareholder and CEO of Scope Fluidics.

The evaluation aims to compare the result of the diagnostic test for SARS-CoV-2 conducted using the PCR|ONE system with the reference diagnostic method used in the laboratory where the tests will take place. The samples to be tested will be acquired from hospitalized patients referred for testing for SARS-CoV-2. The choice of the reference method, clinical sampling and analysis of the results will be carried out in accordance with FDA recommendations and relevant ethical, legal and scientific regulations and standards. The Management Board is planning to complete the tests and obtain FDA EUA certification in Q4 2020.

In May this year, Scope Fluidics announced the completion of the “proof-of-concept” stage of development of the diagnostic panel, which enables ultra-rapid detection of SARS-CoV-2 virus using the PCR|ONE system. The company anticipates the completion of works on the panel in Q4 2020. The development of the panel is expected to increase the business attractiveness of the PCR|ONE system for future buyers.

The PCR|ONE system offers the fastest, multiplex detection of bacteria and viruses in the world (up to 20 different drug-resistant pathogens and genes). The company will offer several panels which address the most severe health hazards. The first one, which is almost completed, is a panel detecting methicillin-resistant Staphylococcus aureus strains (MRSA), which are a common cause of hospital-acquired infections with high antibiotic resistance.

In Q4 2019, the Company successfully completed the second series of pre-validation tests of the PCR|ONE system in ALAB laboratories. The results of the tests confirmed that the clinical parameters of bacteria detection s in compliance with the market standards and clinical requirements. The tests also proved the competitive advantage of the PCR|ONE system, i.e. a unique combination of time-efficiency and comprehensive character of the tests.