Operational Program: Intelligent Development 2014-2020 – “Fast Track”

Project title:

Development of technology and mobile diagnostic equipment based on the lab-on-chip solution for detecting infectious diseases

Project value: PLN 12 210 584.19

Contribution of European Funds: PLN 8 912 385,14

The name of the program:

Intelligent Development Operational Program 2014-2020 – “Fast Track”. Priority axis. Support for conducting R & D works by enterprises. Operation R & D projects of enterprises. Sub-measure – Industrial research and development carried out by enterprises.

Subject of the project

The subject of the project is to develop a product innovation in the form of a portable LOC-type diagnostic apparatus based on LAMP technology and proprietary SNAAT solution for the preliminary detection of infectious diseases, in particular: Chlamydia trachomatis, Chlamydophila pneumoniae, Mycoplasma pneumoniae, Neisseria meningitidis, Neisseria gonorrhoeae, MRSA. With regard to the technology of the control device and the reaction card, the current level of technological readiness is TRL IV, while the level of technological readiness of the molecular technique is TRL III. The introduction of technology to the market requires carrying out R & D works to the level of IX TRL.

Project goals

The main goal of the project is to develop and prepare for the implementation of innovative diagnostic equipment to detect selected infectious diseases, which is a Lab-On-Chip (LOC) solution with an integrated system for isolation of genetic material (thanks to proprietary technology Simplified Nucleic Acid Amplification Technology – SNAAT) and utilizing LAMP (loop-mediated isothermal amplification) DNA/RNA amplification technique. Diagnostic equipment will be used for extraction and concentration of genetic material from biological sample and its amplification, pathogen detection and reading the result using software. It will be the first mobile, relatively inexpensive solution on the market that enable rapid diagnostic tests based on molecular biology techniques at any place by medical personnel, without the need for laboratory experience. Thanks to this, early detection of dangerous diseases and the use of appropriate therapy will be possible.

Planned effects

The target product, after completion of R & D works, will respond to the customers’ expectations:

– provides sensitivity and specificity of the test close to 100%;

– allows the examination to be carried out independently, at any time, in non-mitral conditions, by medical personnel without laboratory experience;

– TAT no longer than 20 minutes;

– sample volume in the range of 100 to 200 μl;

– competitive price;

– high durability during warranty / post-warranty period.

The results of the project are characterized by innovation on a global scale. The novelty of the project’s result on a global scale will be the method of detecting pathogen-specific nucleotide sequences in biological material in a disposable, inexpensive reactor that is capable of performing all analytical steps automatically.