Curiosity Diagnostics – member of the Scope Fluidics S.A. Group – has completed the fifth stage of works on the PCR|ONE molecular diagnostics system on time. This means that the Company has confirmed the clinical performance of the system in external lab tests, launched its own manufacturing line and has just started the process of verification and validation of the system on the way to obtaining CE IVD certification.
The entire team has been working hard for nine months, and we have managed to achieve a lot during this period. We’ve developed and launched our own manufacturing line, with clean zones and manufacturing protocols in place. We manufacture cartridges and analysers. We’ve tested the operation of the system in target conditions, and we achieved high sensitivity and specificity parameters of the most rapid and comprehensive test to detect Staphylocococcus aureus. We’ve prepared a schedule of clinical trials and executed relevant agreements with hospitals. We have also started verification of the system as a part of the implemented ISO 13485 system. It is greatly satisfying to see our long-standing dreams and plans come true, says Prof. Piotr Garstecki, co-founder, key shareholder and CEO of Scope Fluidics.
Tests on clinical samples carried out in November 2019 in ALAB laboratories demonstrated high sensitivity and specificity parameters for all MRSA/SA panel genetic markers. Already in December 2019, the company launched its own manufacturing line, with which it can produce all components of the PCR|ONE system independently. Six analysers have been developed and are currently deployed in the verification process.
The opening of the manufacturing space, with all the required procedures and standards, is a big step towards manufacturing process validation, and the registration and certification of the PCR|ONE system. It also allows us to accurately plan mass production and gives us the ability to efficiently manufacture cartridges in the process of developing new PCR|ONE diagnostic panels, says Marcin Izydorzak, co-founder, key shareholder and member of the Management Board of Scope Fluidics.
The PCR|ONE test is both the most rapid and the most informative test for detecting Staphylocococcus aureus. It examines not only its drug-positive and drug-resistant variants, but also, as the only test in the world, detects at the same time the gene that encodes a dangerous toxin, Panton-Valentine leukocidin (PVL). In January 2020, Curiosity Diagnostics conducted tests on two hundred clinical strains, and obtained full compliance of PVL toxin detection with the reference method, with 100% sensitivity and 100% specificity.
In preparation for the tests that are necessary for the registration and certification procedure of the PCR|ONE system, Curiosity Diagnostics is implementing the ISO 13485 quality management system. Detailed plans for internal verification and external validation of all elements of the PCR|ONE system have been prepared and verification tests for all system modules have been started.
In addition, in order to obtain CE/IVD certification, the clinical tests for the PCR|ONE system have to be conducted by independent research centres. To this end, the company has entered into agreements with three clinical centres in the Mazovia region.
In March, Scope Fluidics also announced the start of work on further development of the PCR|ONE test portfolio. The company decided to extend the work on the panel for the diagnosis of viral respiratory tract infections and develop an ultra-fast test to detect the SARS-CoV-2 virus which causes Covid-19 disease.
The SARS-CoV-2 pandemic has increased the need for rapid, sensitive genetic testing that can be carried out anywhere – not only in the hospital, but also, for example, at the airport, in a retirement home or in a mobile diagnostic facility. Not only the medical community, but also the manufacturers of diagnostic systems are interested in this solution. Although the pandemic threatens smooth implementation of our planned activities, this situation also motivates us. The PCR|ONE system is actually designed for such challenges, because the ease of use, speed and multitude of detected genes are particularly important these days. We are already working on PCR|ONE test for SARS-CoV-2 and will report on progress, comments Prof. Piotr Garstecki, co-founder, key shareholder and CEO of Scope Fluidics.