Curiosity Diagnostics – a member of the Scope Fluidics S.A. Capital Group – successfully completed the second series of pre-validation tests of the PCR|ONE system in ALAB laboratories. The results of the tests confirmed that the clinical parameters of bacteria detection s in compliance with the market standards and clinical requirements. The tests also proved the competitive advantage of the PCR|ONE system, i.e. a unique combination of time-efficiency and comprehensive character of the test for the presence of Staphylococcus aureus.
A series of tests conducted in ALAB laboratories was aimed at testing the key parameters of the PCR|ONE system in target clinical conditions. The most important competitive system, GeneXpert, was also ussed in the tests, and traditional culture methods were applied as the reference.
The study included 193 nasal swabs obtained from patients, which were checked for the presence of Staphylococcus aureus. The sensitivity and specificity of the PCR|ONE system in detection of antibiotic-resistant Staphylococcus aureus were at the level of 100% and 99.4%, respectively. In the case of the antibiotic-susceptible variant of Staphylococcus aureus, the sensitivity and specificity of the system reached the level of 95.8% and 92.4%, respectively. The parameters measured for the competitive GeneXpert system were 100% for sensitivity and 92.5% for specificity. The results also showed that the PCR|ONE system is unrivalled in terms of the rapidness of genetic material analysis
These results are no surprise to us, the current version of the system has already undergone our in-house tests in July this year, before the presentation of the PCR|ONE system at the AACC trade fair in California. The present study confirmed the reliability of the system and the high sensitivity and specificity parameters in the target clinical environment. We are very satisfied because the entire Curiosity Diagnostics team put a lot of work into the optimization of the PCR|ONE system, comments Prof. Piotr Garstecki, co-founder, key shareholder and CEO of Scope Fluidics S.A.
The PCR|ONE system was previously tested in ALAB laboratories in the second half of 2018. At that time, the sensitivity and specificity parameters of the PCR|ONE system, although high, were not sufficient to introduce the system into proper clinical trials, and the reliability of the prototype cartridges also required improvement. The Curiosity Diagnostics team introduced a number of system optimization solutions, including changes in the disposable cartridge architecture, biochemical reactions and analyzer. The results of the current round of research in ALAB showed the legitimacy and effectiveness of those improvements. The levels of sensitivity and specificity of the test, falling in the range between 90-100 percent, are in accordance with market standards. The effectiveness of the system was also significantly increased, from 75% to 92%, thus confirming its reliability.
The results achieved now in ALAB, like the ones obtained in 2018, have provided us with an abundance of information on the clinical performance of the system. The level of results no longer differs from those presented by the market leader. This gives us great comfort in continuing our work on production implementation, clinical trials, the search for potential clients – for whom system performance in clinical conditions is of paramount importance, comments Piotr Garstecki.
The development of the project is progressing in line with the assumed schedule. The next step will be to launch a production line for cartridges and analyzers to the extent necessary to conduct pre-registration tests. The start of pre-registration tests, required under the registration and certification procedure of the PCR|ONE system, is planned for the next year. Completion of works on the project and obtaining the CE-IVD certificate, which will enable the introduction of the system on the European market, is planned for Q2 2020.
The PCR|ONE system offers the world’s most rapid detection of bacteria and viruses (up to 20 different pathogens and drug resistance genes). Quick and accurate identification of microorganisms that cause, among other things, HAIs, is vital for proper treatment and preventing the spread of germs.