Curiosity Diagnostics Sp. z o.o., a Warsaw, Poland-based biotechnological company owned by Scope Fluidics S.A., a listed company on the NewConnect stock exchange (an organised market operated by the Warsaw Stock Exchange for young, dynamic Polish companies), announced that it has successfully completed the first series of functional tests for its PCR:ONE System conducted in ALAB laboratories. The tests confirmed the potential of the system to become world’s most rapid analyser capable of performing automatic and complex diagnosis of hospital-acquired infections. The system has also obtained high values of the key clinical parameters, namely for sensitivity and specificity. Further, the first tests conducted on clinical samples proved to be similar to those obtained by a major market competitor, but with a significantly shorter test time.
The PCR|ONE system was tested by an independent, certified microbiological laboratory owned by ALAB Laboratoria Sp. z o.o. – one of the largest Polish networks of diagnostic laboratories. Pre-validation of the PCR|ONE system consisted of conducting tests on over 60 different strains of Staphylococcus aureus isolated from patients (tests on isolates), as well as directly from patients’ nasal swabs (tests on nasal swabs). The latter tests were conducted simultaneously on the PCR|ONE system and on a competitive system. The results were compared to standard bacterial cultures methods.
The programme had three major aims: i) to check the sensitivity and specificity of the assays of a wide range of Staphylococcus aureus clinical strains; ii) to conduct the first large-scale test of the PCR|ONE system on clinical nasal swabs; and, iii) to evaluate the functionality of the system by the diagnostic personnel. These results provide Scope Fluidics with precise guidelines for what is believed to be the last phase of the PCR|ONE system optimization,
“The comprehensive report provided to Scope Fluidics by ALAB Laboratoria is a very important validation of the of the PCR|ONE system as verified in a target diagnostic environment. These tests confirmed the effectiveness and rapid speed of testing. Moreover, the conclusions deliver certain necessary data for our final system optimization in the course of the industrialization process. At this stage, we will focus on implementing improvements into selected biochemical reactions and elements of disposable panel’s architecture. These works are already in progress,” says Prof. Piotr Garstecki, co-owner, key shareholder and CEO of Scope Fluidics S.A.
In order to prove that the system is capable of detecting clinical strains of Staphylococcus aureus, tests on the so-called isolates – bacteria isolated from samples collected from patients – were conducted. 61 out of 62 samples analysed by the PCR|ONE system contained Staphylococcus aureus, and 32 strains were antibiotic-resistant. The system correctly detected the presence of bacteria in all tested samples, and the resistance to antibiotics (or lack thereof) was assayed correctly in 60 samples. The results indicate that the PCR:ONE system works effectively with a wide range of pathogens which it will encounter in the clinical environment.
The tests conducted in ALAB laboratories were also the first large test of the system on target samples collected directly from nasal swabs. The system correctly assayed the presence of Staphylococcus aureus in 115 of 126 tested samples, and the presence of drug resistance genes in 100 samples. In the tested samples, the PCR|ONE correctly detected drug-resistant Staphylococcus aureus. However, the system proved to be “hypersensitive” – it indicated the presence of antibiotic resistant genes in 26 samples in which the bacteria was not drug-resistant – which lowers the specificity-related performance of this method.
“The results are of crucial importance to us – they have proved that system operates correctly and that the PCR method is sufficiently sensitive. Lowered specificity does not surprise us – we anticipated it – because the cartridges tested in ALAB had been created in our laboratories where, despite utmost diligence, it is not possible to eliminate entirely the transfer of genes, which are multiplied in PCR reactions in massive quantities, to the room where the panels are manufactured. Even a single copy of a DNA molecule transferred on a cartridge may subsequently be detected in our system, even though the swab sample does not contain that gene. Ultimately, the panels will be manufactured in an isolated and controlled environment. This will allow PCR:ONE to obtain test’s specificity similar to that of competitive systems” says Piotr Garstecki.
The usability of the PCR|ONE system was also evaluated by specialists from ALAB laboratories. The report highlights the compact size, ergonomic design and ease of use of the system. Moreover, it underlines the short time needed to obtain test results, which currently is 20 minutes. The company believes that this turn-around-time will be reduced to ca. 15 minutes. In comparison, a competitive system requires ca. 1.5 hours to analyse a sample.
The completion of works on the project and its sale to a global partner is planned to take place in Q2 2020. The system optimization process is to end in mid-2019.