Scope Fluidics completes clinical trials of a rapid PCR|ONE genetic test for detecting Staphylococcus aureus and its drug-resistant variants (MRSA)


grafikaScope Fluidics – a biotechnological company listed on NewConnect, developer of innovative medical diagnostics projects – has completed the process of clinical trials for a methicillin-resistant Staphylococcus aureus (MRSA/MSSA) panel. This is a very important step towards the placement of the PCR|ONE panel MRSA/MSSA system on the market in the European Union. The global market for Staphylococcus aureus testing systems is currently worth approximately USD 105 million.

The MRSA/MSSA panel of the PCR|ONE system is an ultra-fast diagnostic system designed to detect Staphylococcus aureus infection. The Company has just completed clinical certification testing of this system. In view of the results obtained, the Company intends to apply for marketing authorization in the European Union for the PCR|ONE system, MRSA/MSSA panel. To this end, the Company is going to file a notification with the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) to register the PCR|ONE system, MRSA/MSSA panel as an in vitro diagnostic medical device. If the President of UPRL does not issue any remarks within 14 days, it will be possible for the PCR|ONE system, MRSA/MSSA panel to use the CE-IVD marking, which in turn will allow for the marketing of the system in the European Union.

Based on the data obtained, a final report of the clinical trial has been drafted. The data presented therein confirm the effectiveness of the PCR-ONE system for the target diagnostic environment. The system for detecting Staphylococcus aureus and its drug-resistant variant (MRSA/MSSA) obtained high values of key clinical parameters: for the drug-susceptible form of Staphylococcus aureus the sensitivity of 96.8% and specificity of 97.1% was achieved, while for the drug-resistant variant of Staphylococcus aureus the sensitivity of 95% and a specificity of 100% was recorded.

–We are pleased to announce the attainment of an important step towards the commercialisation of PCR|ONE, an ultra-rapid genetic diagnostic system. We have completed the clinical effectiveness trial of the test for the detection of Staphylococcus aureus infections.. This is a great moment for us and the result of synchronised work of the entire Curiosity Diagnostics team. Looking ahead, this is when we start building a portfolio of rapid genetic tests for the PCR|ONE system, which is a universal platform allowing panels to be created in response to a wide range of clinical and epidemiological needs – says Professor Piotr Garstecki, co-founder and CEO of Scope Fluidics..

MRSA is commonly found in hospitals and healthcare facilities and may cause serious health problems such as pneumonia, blood infections, septicaemia and even death. The US Center for Disease Control and Prevention (CDC) identified MRSA as posing a serious threat of antimicrobial resistance. The pathogen is resistant to a number of common antibiotics, meaning that if infections develop, treatment and monitoring may be extremely difficult.

At the same time, the outbreak of the SARS-CoV-2 coronavirus pandemic has caused a short-term significant increase in MRSA infections. Due to the prolonged pandemic, market demand for MRSA/MSSA detection tests and antibiotic treatments for MRSA/MSSA is expected to remain elevated [[1]].[[1]]. The market of methicillin-resistant Staphylococcus aureus (MRSA) testing systems was estimated to be worth USD 105 million in 2020. It is expected to grow at an average annual rate of 10.5 percent between 2020 and 2027, to reach USD 205 million in 2027.[[2]].

Scope Fluidics has also announced that it has commenced pre-registration trials for the SARS-CoV-2 panel at a new clinical center, following the decision to include a Point-of-Care reference method in the study. The company anticipates that the clinical trials necessary to obtain certification and marketing authorization for the product will be completed in Q2 2021. The company plans to incorporate the results of the SARS-CoV-2 panel certification trials into the documentation required for European CE-IVD certification and US FDA certification under the special pandemic-related EUA pathway.