PCR|ONE System receives European CE-IVD certificate for its MRSA/MSSA panel

The ultrafast PCR|ONE System, developed by Curiosity Diagnostics, a wholly own SPV of Scope Fluidics S.A., received the European CE-IVD certification for the diagnosis of methicillin-resistant Staphylococcus aureus (MRSA). The PCR|ONE System is capable of detecting on a molecular level dangerous bacteria and viruses in a breakthrough time of just 15 minutes.  Scope Fluidics believes that within Early Access Program this system is likely to become a permanent fixture in EU laboratories and hospitals later this year. The MRSA/MSSA panel of the PCR|ONE system is already listed in the EU register of medical devices used for in vitro diagnostics. Scope Fluidics is a NewConnect – listed biotechnology company that develops innovative projects in the field of medical diagnostics.

PCR is in most cases a gold standard technique in diagnostics. It is extremely sensitive – it can detect
a single DNA molecule. Curiosity Diagnostics began clinical certification testing of the MRSA/MSSA panel for detecting Staphylococcus aureus in February 2021. The system achieved high values for key clinical parameters for the determination of Staphylococcus aureus and its drug-resistant variant.
For the drug-sensitive form of Staphylococcus aureus, 96.8% sensitivity and 97.1% specificity were achieved, while for the drug-resistant variant of Staphylococcus aureus these values reached 95%
and 100%, respectively.

The PCR|ONE system is a complete, stand-alone system designed for the immediate point-of-care detection of a wide range of pathogens and genetic targets at doctor’s offices, hospital emergency rooms, and other locations where rapid and accurate patient diagnosis is important. The system offers easy-to-use, disposable clinical sample panels that are automatically processed for detailed diagnosis in just 15 minutes. The PCR|ONE system provides a unique combination of record speed and a range of up to 20 genetic targets in triplicate that are identified in a single run of the instrument cycle.

The positive results of the PCR|ONE system with the MRSA/MSSA panel resulted in the issuing of a certificate allowing its use in the European Union, confirming its compliance with EU standards and the requirements of all relevant European directives for medical devices. The CE mark (Conformite Europenne) is a legal requirement for placing a product on the market.

The next step on the way to commercialization of the system is the commencement of an Early Access Program in Q3 2021.

– As part of the Early Access Program, we intend to introduce to the market the MRSA/MSSA panel,
and at a later stage also the SARS-CoV-2 panel (after CE-IVD certification). We are engaging with key reference and opinion-forming centers in order to identify the markets (users) that will be the first recipients of our products and to prepare the right tools to support our PCR|ONE system in the sales process. Consultations in selected centers in Europe will help us obtain the data and necessary information for the continuous improvement of our system. The European Union certificate
for the MRSA/MSSA panel is important in the development of PCR|ONE, which the Scope Fluidics team has been developing since 2012
, says Piotr Garstecki, CEO of Scope Fluidics Group.

– The exceptional functionality of the PCR|ONE system, protected by patents in the US, EU and China
is of particular practical and economic value in the era of the COVID-19 pandemic. I visited the Scope Fluidics team and learned of their projects in 2018. In 2019, the PCR|ONE system was a semi-finalist
of the 2019 AACC Disruptive Technology Award. I am pleased to see how the concept of an ultrafast and highly complex PCR system is now a commercially available product in Europe and further
in the United States
, says Professor Carl Wittwer, cofounder of BioFire and Scope Fluidics’ Advisory Board Member.

Staphylococcus aureus bacteria cause a range of serious diseases such as pneumonia and septicaemia, and their widespread presence in hospitals and healthcare facilities poses a serious threat to patients throughout the world. The pathogen is resistant to many antibiotics. The SARS-CoV-2 coronavirus pandemic has caused a significant increase in infections due to the presence of more patients in medical facilities. Ultra-fast PCR|ONE diagnostics enables sample-to-answer results in 15 minutes – in a hospital emergency room, at a doctor’s office, or anywhere else the test is needed.

The market for methicillin-resistant Staphylococcus aureus (MRSA) testing was 105 million USD in 2020 and is expected to grow at an average annual rate of 10.5% to reach 205 million USD in 2027 [[1] ].

[1] https://www.coherentmarketinsights.com/market-insight/methicillin-resistant-staphylococcus-aureus-testing-systems-market-3803

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