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European CE-IVD certificate for ultra-fast, fully automated SARS-CoV-2 virus detection test by Scope Fluidics

Developed by Curiosity Diagnostics, a wholly-owned subsidiary of Scope Fluidics S.A., the PCR|ONE SARS-CoV-2 panel is now CE-marked and can be introduced to the European market. The PCR|ONE SARS-CoV-2 panel is one of the fastest tests in the world, and is uniquely suited for near patient testing.  The SARS-CoV-2 product expand the menu of test available on the PCR|ONE system, which already includes methicillin-resistant Staphylococcus aureus (MRSA/MSSA panel).

The PCR|ONE system uniquely combines several key parameters such as ease of use, affordable cost, very short testing time and informativeness. Among all the rapid genetic tests for SARS-CoV-2, the PCR|ONE test is the most reliable method of detecting SARS-CoV-2 and also one the fastest on the market.   A number of testing locations will benefit from the system’s unique performance, especially where fast and accurate diagnosis is important – from medical centers to any location frequented by the public.

The certification of the first PCR|ONE panels represents the culmination of nine years of work, but also the opening of a new phase. We are successfully fulfilling our vision to provide users with fast, sensitive and easy to use tests. It is also a very good starting point for expanding our portfolio of panels which verify the presence of many different pathogens in a single test in ultra-rapid time, Professor Piotr Garstecki, CEO of the Scope Fluidics group, says. Certification of the first two tests for detection of bacteria, and now for detection of an RNA virus, constitute a very important milestone in commercialization of the PCR|ONE system.

 The PCR|ONE system for SARS-CoV-2 virus detection successfully passed in-depth testing in external hospital laboratories, achieving very high values for the most relevant clinical parameters: 91.2% sensitivity and 100% specificity. On the other hand, in the analysis of samples containing higher amounts of viral RNA (samples from patients likely to infect other people), the PCR|ONE system proved flawless, obtaining 100% sensitivity and 100% specificity. PCR|ONE with the SARS-CoV-2 panel was also tested the PCR|ONE system at the Warsaw Chopin Airport, where passengers from almost all over the world arrive (collaboration with the Central Clinical Hospital of the Ministry of the Interior and Administration).

PCR|ONE is designed to test for a number of targets in the SARS-CoV-2 genome.  As such it can be easily adapted to include new genetic targets to timely address the threat posed by new variants of the virus. It is a system that has an enormous growth potential – as a powerful tool to fight the COVID-19 pandemic and also a number of other conditions where a timely diagnosis allows for rapid  initiation of treatment and improvement in patient outcome, says Vincent Linder, Ph.D., author of more than 300 patents in microfluidic techniques and point-of-care diagnostics, founder of a diagnostics startup at Harvard University, and member of the Scope Fluidics Board of Experts.

Once it became clear to us that the healthcare systems around the world would need improved diagnostics tools like the PCR|ONE system to fight the COVID-19 pandemic, we quickly added a development arm to deliver a SARS-CoV-2 panel.  With an original focus on bacterial testing, Curiosity Diagnostics effectively modified the PCR|ONE to be capable of testing for viruses.

We have demonstrated the versatility of the PCR|ONE system. We knew that it could be used to identify bacterial DNA along with checking their antibiotic susceptibility. Now we know that it can also be used to identify virtually any pathogen in the world. This will open way for a very broad application of the PCR|ONE system in medical diagnostics, says Dr. Kamil Gewartowski, PCR|ONE project manager at Scope Fluidics.

The number of people in the world confirmed to be infected with the SARS-CoV-2 virus has exceeded 194 million to date. More than 4.1 million patients have died from Covid-19 since the outbreak of the pandemic. It was proved in practice that the rapid and effective diagnosis is a key element in the fight against the spread of infection. The SARS-CoV-2 virus diagnostics market is estimated to be worth $84.4 billion by 2021. The market is expected to grow to USD 195.1 billion by 2027, at a compound annual growth rate (CAGR) of 15.0% from 2021 to 2027 (ref. https://www.bccresearch.com/market-research/medical-devices-and-surgical/covid-19-diagnostics-market-report.html).

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European CE-IVD certificate for ultra-fast, fully automated SARS-CoV-2 virus detection test by Scope Fluidics