Curiosity Diagnostics, a company belonging to the Scope Fluidics S.A. Capital Group, has completed the fourth stage of R&D works on the PCR|ONE system for automatic analysis of the genetic material of the bacterial and viral pathogens, unmatched on account of the speed and comprehensiveness of testing. This means that the PCR|ONE system is available for tests in target conditions. The testing will be carried out by an independent partner – ALAB Laboratoria.
The first round of testing in ALAB Labs was completed in the second half of 2018. At that time, PCR|ONE system managed to obtain high responsivity and specificity parameters compared to a competitive product, and it confirmed its absolute superiority in terms of the speed of analysis of the genetic material. Scope Fluidics used the conclusions and recommendations gathered in the testing process to further optimize the functionality of the system and the production cost of disposable cartridges, company. The second round of testing will be conducted in July 2019 and will end in Q3 2020 at the latest.
In recent months, Scope Fluidics has achieved its strategic goals: optimization of the system functioning and commissioning of the chips production line. The company also managed to manufacture three PCR|ONE analyser devices.
We’ve decided to take advantage of the large number of genes detectable via the PCR|ONE platform, and we have introduced new markings, which improve the specificity of differentiation between the antibiotic resistant (MRSA) and antibiotic-sensitive (MSSA) staphylococcus genes. The last months were also devoted to simplifying the procedure of disposable cartridge production and reducing its costs. We are very optimistic about the second stage of testing in ALAB Laboratoria – says Prof. Piotr Garstecki, co-owner, key shareholder and CEO of Scope Fluidics S.A.
The completion of the project works and CE-IVD certification, which allows to introduce the system on the European market, is planned for Q2 2020. The PCR|ONE system offers the fastest detection of bacteria and viruses in the world (up to 20 different drug-resistant pathogens and genes). The company will offer two panels which address the most severe health hazards. The first one is a panel detecting methicillin-resistant Staphylococcus aureus strains (MRSA), which are a common cause of hospital-acquired infections with high antibiotic resistance.
Timely completion of work on analysers and disposable cartridges, preparing us for PCR|ONE system tests in diagnostic laboratories, is particularly important for us, because in just a few weeks we will be presenting our system in the Innovation Zone at AACC Expo – the largest diagnostic fair in the world – comments Szymon Ruta, CFO and member of the board of Scope Fluidics. The American Association for Clinical Chemistry’s Disruptive Technology Award for the PCR|ONE system in the competition for the most groundbreaking diagnostic technology confirms the unique combination of speed of action and the informative potential (number of genes marked) offered by PCR|ONE, which addresses the dynamically growing molecular diagnostics market. According to Markets and Markets, the global value of this market in 2021 will amount to USD 10.1 billion, which, with the current value of USD 6.5 billion, means an average annual growth rate of over 9%.