The title of the project:
Developing a portable diagnostic device based on lab-on-chip analysis system to detect COVID-19 disease (SARS-CoV-2 pathogen).
Project value: PLN 12 210 584.19
Contribution of European Funds: PLN 8 912 385,14
Programme name:
Smart Growth Operational Programme 2014-2020 – “Fast track”. Priority axis. Support for R&D activity of enterprises Measure: R&D projects of enterprises Sub-measure: Industrial research and development work implemented by enterprises.
The subject of the project:
The subject of the project is developing the product innovation in the form of portable LOC diagnostic device utilizing the LAMP technology and the proprietary SNAAT solution for initial detection of infectious diseases, especially Chlamydia trachomatis, Chlamydophila pneumoniae, Mycoplasma pneumoniae, Neisseria meningitidis, Neisseria gonorrhoeae, and MRSA. For the controlling device and reaction card the current technology readiness level is TRL IV, while for the molecular method it is TRL III. Placing the technology on the market requires conducting R&D works up to TRL IX.
Project goals:
The main goal of the project is to develop and prepare for implementation an innovative diagnostic device for detection of selected infectious diseases, which is a Lab-On-Chip (LOC) solution with an integrated system for genetic material isolation (utilizing proprietary Simplified Nucleic Acid Amplification Technology – SNAAT) and using loop-mediated isothermal amplification (LAMP). The diagnostic device is intended for isolation and concertation of genetic material from a biological sample, its amplification, pathogen detection and signal readout using software. This is going to be the first on the market, mobile, relatively inexpensive solution that allows fast diagnostic tests based on a molecular biology method in any place, by health care professionals with no lab experience. This will enable early detection of dangerous diseases and application of appropriate treatment.
Planned results
The final product, after completion of R&D works will be response to customer expectations:
– providing test sensitivity and specificity close to 100%;
– allowing the test to be conducted at any time, under non-laboratory conditions, by medical staff with no experience in laboratory diagnostics;
– enabling test results within 20 minutes from the time of the test;
– allowing testing using very small samples of biological material, i.e. 100 to 200 µl;
– competitive pricing;
– ensuring high durability during the warranty/post-warranty period.
The project results exhibit innovation on a global scale. The method for detecting nucleotide sequences, characteristic for pathogens in biological material using a disposable, cheap reactor that allows complete treatment and analysis of biological material, makes the project novel and innovative on a global scale.
