Scope Fluidics has developed an ultra-fast PCR|ONE genetic test for coronavirus

Curiosity Diagnostics, owned by Scope Fluidics – a biotechnological company listed on NewConnect, owner of innovative medical diagnostics projects – has successfully completed the “proof-of-concept” stage of development of the diagnostic panel which enables ultra-fast detection of the SARS-CoV-2 virus using the PCR|ONE system. Now, the company is going to optimize, analyse and validate the test. The company plans to complete work on the panel already in 2020, based on the funds it holds, as well as funds from the European Union and other public institutions supporting the development of modern technologies and health care. The creation of the panel is to increase the business attractiveness of the PCR|ONE system from the point of view of the future purchaser.

– – Thanks to the great determination of the whole team, we have reached the “proof-of-concept” stage of the PCR|ONE panel for detecting the SARS-CoV-2 virus. We have developed a number of key stages and confirmed the possibility of detecting the RNA of the virus in approx. 15 minutes, counted from the application of the sample until the result is obtained, in a fully automatic procedure. This type of test is the safest and easiest to do, and with this pace of progress we can plan to launch the test already this year – – says Prof. Piotr Garstecki, co-founder, key shareholder and CEO of Scope Fluidics.

Over the past few weeks, the following tasks have been completed under the “proof-of-concept” phase:

1. Development of RNA isolation on a PCR|ONE cartridge previously used in the MSSA/MRSA panel.
2. Implementation of the reverse transcription reaction to the cartridge as a single-stage RT-PCR reaction.
3. Development of a method of reverse transcriptase freeze-drying in the reconstitution chamber so as not to adversely affect the freeze-drying of the remaining components of the PCR mix.
4. Designing, testing and selecting a set of starters specifically detecting all previously deposited SARS-CoV-2 clones.
5. Development of an internal control in the form of eukaryotic RNA deposited in the sample chamber and detected by RT-PCR.
6. Integration of all the above issues in the form of a series of tests performed automatically using the PCR|ONE system. The test results correctly reflect the detection of positive control (containing RNA of SARS-CoV-2 virus) and negative control (not containing such RNA) placed in the sample chamber.

–The PCR|ONE system has demonstrated its advantages – one of them is easy adaptability to new diagnostic panels. We developed our first ever RNA detection test, which forced us to develop a number of new sample preparation stages, and our team did so within a few weeks. In the future, extending the panel to detect new RNA or DNA sequences will be even faster. This work resulted in positive internal tests which confirmed the ability of the PCR|ONE system to detect coronavirus ultra-fast. Now, we have to move on with the development of manufacturing processes, verification and validation tests – explains Piotr Garstecki.

In the upcoming months, the following actions will be taken on the way of introducing the panel to the market:

1. Continuation of work and improvement of applied biochemical and engineering solutionsensuring high quality diagnostic tests.
2. Conducting a series of internal and external tests.
3. Development of documentation related to the quality management system.
4. Conducting pre-registration tests.
5. Product registration.

The PCR|ONE system offers the most rapid detection of bacteria and viruses worldwide (up to 20 different pathogens and drug resistance genes). The company will offer a few panels targeted at the most serious threats to human health. The first one, on which work is almost completed, is a panel detecting methicillin-resistant strains of Staphylococcus aureus (MRSA), which are a frequent cause of hospital-acquired infections demonstrating high antibiotic-resistance.

In Q4 2019, the Company 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 tests.

At the end of last year, Scope Fluidics acquired PLN 14 million through the issue of shares. The majority of these funds is to be used to increase the market potential of the PCR|ONE system, including the expansion of the portfolio of diagnostic panels – the SARS-CoV-2 detection panel will be one of them. In addition, the capital will be used to prepare for the process of registration of the system in the U.S., strengthen the protection of intellectual property, as well as to conduct tests in leading clinical centres. One of the reasons for raising funds by Scope Fluidics was also the need to provide an appropriate level of cash to strengthen the negotiating position in talks with potential buyers of the PCR|ONE system.

– The coronavirus has halted the world. We have to let it go running once again. The ability to perform the tests is crucial to trigger the economy while protecting the most vulnerable groups of people. PCR|ONE offers a rapid and informative genetic test. Moreover, it is very easy to perform – this allows us to detect the coronavirus in a point-of-care manner. In practice, this means that such devices could be located not only in hospital emergency rooms, but actually everywhere where people gather. From airports and train stations to nursing homes. The potential buyers of the system are aware of these possibilities – says Piotr Garstecki.