Scope Fluidics – a biotechnological company listed on NewConnect, owner of innovative medical diagnostics projects – has launched its own semi-automatic manufacturing line in Warsaw, which allows for independent production of chips. The manufacturing infrastructure is also capable of assembling PCR|ONE analyzers. This event is a part of the implementation of the milestone associated with the execution of pre-registration tests.
In March 2019, Scope Fluidics decided to independently manufacture individual components of the PCR system for the purposes of pre-registration testing. The company also updated the schedule of works on its systems (originally Scope Fluidics planned to subcontract these tasks). The decision was motivated by the reduction of some costs in comparison to outsourcing of the manufacturing process, as well as by increasing control over intellectual property and maintaining a greater impact on the timely completion of key stages of the projects.
The assumed capacity of the manufacturing line will enable independent production of chips and PCR|ONE analyzers to the extent that is necessary to conduct pre-registration tests, as required under the certification and registration process of the system in the European Union.
According to the schedule, we have completed another important task within the milestone related to pre-registration testing. The technology of the PCR system is now ready. We are working on the implementation and validation of the manufacturing process of this system, and the opening of the manufacturing line in the new location is a crucial element of this process. We are planning to obtain the certification necessary for the introduction of the system to the European Union market in the middle of next year. We are convinced that soon afterwards we will commercialize the most rapid and comprehensive Point-of-Care system – PCR|ONE, says Prof. Piotr Garstecki, co-founder, key shareholder and CEO of Scope Fluidics.
First of all, the manufacturing line will be used for the production of disposable PCR|ONE chips. The company announced the production of a sample batch of chips. Ultimately, the line will also be used for the assembly of PCR|ONE analyzers. The independent assembly of the analyzer will be launched by the end of Q1 2020.
The prepared manufacturing area is characterized by increased cleanliness and the ability to control the conditions of the manufacturing environment. Increased cleanliness results in a limited number of mechanical impurities and DNA impurities present in the manufacturing environment.
“The transition from the stage of technology development to the manufacturing process under controlled conditions, in accordance with the requirements of system certification, is a great challenge for our organization. The whole team participates in the implementation of the quality management system and the transfer of technology to production. The opening of a new, dedicated manufacturing area, with all the required procedures and standards in place, is a great step towards the validation of the manufacturing process and the registration of the system,” adds Marcin Izydorzak, co-founder, key shareholder of Scope Fluidics and CEO of Curiosity Diagnostics SPV.
The PCR|ONE system offers the world’s most rapid detection of bacteria and viruses (up to 20 different pathogens and resistance genes). The company will offer several test panels targeted at the most serious threats to human health. The first one, which is almost completed, is a panel detecting methicillin-resistant Staphylococcus aureus strains (MRSA), which are a frequent cause of hospital-acquired infections.
At the beginning of November 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 is 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.
Manufacturing line also tailored to the needs of the BacterOMIC project
In the future, the new manufacturing area will enable independent production of chips and analyzers also for the BacterOMIC system, to the extent necessary for pre-registration testing, certification and registration of the system in the EU.
The certification of the BacterOMIC system is scheduled for mid-2021. We have designed the manufacturing line so that it is also suitable for the production of components for this project. From the company’s perspective, this is an additional element that justifies, from an economic point of view, the decision to launch its own manufacturing line instead of outsourcing this process, says Prof. Piotr Garstecki.
The BacterOMIC system is to respond to the growing phenomenon of antibiotic resistance of bacteria. The Company’s product is to accelerate and increase the effectiveness of patient treatment by identifying the best targeted therapies for a given patient. Within a few hours, it will precisely assess the susceptibility of bacteria to all clinically important antibiotics and will provide the physician with comprehensive information on the pathogen. The BacterOMIC system will use classical microbiological methods for antibiotic susceptibility testing, combined with the innovative microfluidic technology. The main competitive advantage of BacterOMIC will be a much greater complexity of the test than in any other system available on the market. Furthermore, this project has the potential to be the first automatic diagnostic system for testing antibiotic combinations in cases of the most difficult infections, where no single administered antibiotics are effective.
At the end of November, the Company successfully completed the second series of external pre-validation tests of the BacterOMIC system, which were conducted by the National Tuberculosis and Lung Diseases Research Institute in Warsaw. Comparative tests with the system which is currently the market leader confirmed that cartridge preparation procedures, cartridge use protocols and the functioning of the entire system, including the data analysis modules, work correctly. On their basis, further improvements to the system will be implemented. The BacterOMIC system was assessed by the laboratory staff of the Microbiology Department of the Institute as offering the operation complexity that is comparable to the market methodologies known to them.