Scope Fluidics S.A., a NewConnect-listed biotech company developing innovative projects using microfluidic technologies for molecular diagnostics, is beginning distribution of its PCR|ONE system under the Early Access Programme. The Polish distributor, Bioanalytic sp. z o.o., is responsible for the distribution of the system to end users. The analysers and cartridges will be delivered to selected research centres. Among its results, the cooperation will see publication of the findings of the research.
PCR|ONE is a rapid and automated system for real-time gene diagnostics of patients in hospitals, EDs, outpatient clinics and Points-of-Care (PoC). As part of the PCR|ONE system, the Company has developed two diagnostic panels: SARS-CoV-2, designed to detect the virus that caused the 2020 pandemic, and the MRSA/MSSA designed to detect methicillin-resistant or -sensitive Staphylococcus aureus bacteria. The PCR|ONE system offers an extremely easy procedure to perform the genetic test in disposable cartridges, in a fully automated procedure, in an extremely short time of 20 minutes.
The commencement of the PCR|ONE system’s distribution is a new stage of the Early Access Programme (PEA) and is the result of intensive work on the project carried out by the Curiosity Diagnostics sp. z o.o. team earlier this year. Optimisation of the system, improvement of cartridge production, validation studies, and CE certification all have a significant impact on the commercial value of the project. The PCR|ONE system is set to head to research and peer-reviewed centres, where the functionality and usability of the system will be evaluated at its final destination.
– This is a very important moment for us in the course of the Early Access Programme. Evaluating the performance of PCR|ONE under real and targeted use conditions will allow us to adequately prepare for the start of large-scale production. We want the results of the study to be eventually published by peer-reviewed centres. We are pleased with the readiness of our system and look forward to receiving feedback from a wider audience,” – says Piotr Garstecki, President of the Management Board of Scope Fluidics S.A.
Both innovative panels: SARS-CoV-2 and MRSA/MSSA have been developed in response to the diagnostic market’s needs that remain relevant today.
– Although many countries have already lifted Covid-19 restrictions, the pandemic has brought a lot of change in the current approach to testing at medical facilities and by patients themselves. Scientists predict that the SARS-CoV-2 virus will remain with us for many years to come, which is what we are currently experiencing seeing new waves of cases of new virus variants. Therefore, the possibility of rapid diagnosis and applying preventive measures to patients testing positive is extremely important. We expect the demand for fast, easy to use genetic diagnostics to remain at a very high level – says Piotr Garstecki.
The global COVID-19 diagnostics market was valued at USD 97.4 bln in 2021 and is expected to grow at a compound annual growth rate (CAGR) of 7.7% from 2022 to 2030 (Grand View Research). Molecular testing (PCR) accounted for 67.1% of the global revenue share of this market in 2021. The PCR technique is considered the most accurate for detecting COVID-19 and is therefore preferred by laboratories, hospitals, diagnostic centres and outpatient clinics, and research institutes, among others.
On a growth trend is also the market for MRSA (methicillin-resistant Staphylococcus aureus) testing systems. According to analyst estimates, this market was worth around USD 211.3 mln in 2020 and was projected to grow at an average annual rate of around 10.5% until 2027 (Coherent Market Insights). At the same time, the market is forecast to grow by further USD 518.33 mln between 2021 and 2025 with a CAGR of approximately 12% (Technavio).
The Early Access Programme is a framework plan of activities intended to build market recognition for the PCR|ONE system, to evaluate it, to obtain publications from peer-reviewed research centres, to test the system in-house at its final application sites, and to launch the manufacture of cartridges.
As part of its PCR|ONE system, Scope Fluidics S.A. is also working on a panel designed to diagnose influenza A and B viruses and RSV. Certification of this panel is going to involve the CE-IVDR mode.
The PCR|ONE technology is being developed within the special purpose vehicle Curiosity Diagnostics sp. z o.o. In accordance with the Scope Fluidics S.A. business model, work on the project is carried out by a dedicated team of microbiology scientists and high-class engineers and technicians, which may ensure synergistic and uninterrupted R&D processes in the company’s own laboratory.