Summary
- Profile Type
- Technology offer
- POD Reference
- TOPL20231109012
- Term of Validity
- 15 November 2023 - 14 November 2025
- Company's Country
- Poland
- Type of partnership
- Commercial agreement with technical assistance
- Targeted Countries
- All countries
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General information
- Short Summary
- The Polish SME from medical sector has developed innovative diagnostic method (European patent granted) for the detection and species identification of tuberculosis mycobacteria (MTB complex) and MOTT (mycobacteria other than M. tuberculosis). The company is looking for investors among pharmaceutical and diagnostic companies to sell the patent as well as hospitals and large medical entities to conclude license agreements especially in Bulgaria, Romania, Ukraine, India, and African countries.
- Full Description
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The Polish company located in the centre of the country was established in 2016 by Doctor of Medical Sciences, specialist in clinical microbiology. The founder built a research team that developed an analytical method of innovative diagnostics of Mycobacterium tuberculosis and other mycobacteriosis (MOTT) using mass spectrometry technology. It is a reliable response to the market demand for new diagnostic methods. According to the WHO’s expectations, the TB diagnostic method should be fast, accurate, safe, personalised, and allow for quick identification of the drug resistance and be available at the place of treatment. All these premises are met by the developed test.
In September 2021 the M-Typer medical device obtained a positive result from international search, which shwed no similar solution. In May 2022 the M-Typer product was registered at the Office for Registration of Medical Products, Medical Devices and Biological Products and became legally valid for use in the EU. In July 2023 the European patent was granted.
The developed method is based on the simultaneous monitoring of 52 unique mycolic acids through identical fragmentation reactions (SRM/MRM). The mutual relations between signals from individual mycolic acid in relation to the highest one creates a so called mycolic acid profile (MA), which acts as the basis for differentiating bacilli.
The M-Typer software is used to analyse data obtained using the tandem mass spectrometry technique. Its purpose is to assess the similarity between the examined samples and samples found in the library, obtained using the same measurement method. The software was developed and predefined to compare the results of analyses of mycolic acids (MA) using the FIA-MS/MS method (flow-injection tandem mass spectrometry) in the chemotaxonomy of bacilli from the Mycobacterium genus.
The idea behind M-Typer is based on the assumption that the Contractor’s lab, possessing the required knowledge and collection of reference strains, will be able to create and update a library of measurement data, which it will be able to provide to any number of users together with the measurement method. Users will be able to use the research method without having to possess the above-mentioned specialised knowledge. The software is compatible with all models of tandem mass spectrometers manufactured by Sciex®. The company has also undertaken steps to transpose M-Typer for the use on the mass spectrometers manufactures by Shimadzu.
The M-Typer app is addressed to end users who analyse test results using the mass spectrometry method, comparing collected samples with reference data found in a library prepared by the Polish company. In this way, the user is able to confirm the presence and phylogenetic (taxonomic) origin of bacilli from the Mycobacterium genus. As the application is meant for end users, the user interface can be translated into different languages (currently available in English and Polish).
Approximate maximum capacity of the M-Typer diagnostic method in 1 hospital which is organizing 1 mass spectrometer laboratory:
- maximum one-off capacity of mass spectrometer – 100 samples
- 200 samples/day x 240 working days per annum = 48.000 tests
- 48.000 tests x 10 years (licence period) = 480.000 tests
Sale conditions:
- cost of the set of reagents (includes 200 tests) – 2400 EUR/set (net amount – 12 EUR/sample
- cost of M-Typer license for 1 mass spectrometer – 500.000 EUR (net amount) – ca. 1 EUR per test
- license period – 10 years
The Polish company offers its patent for sale or shares for investors among the global companies from pharmaceutical or clinical diagnostics sector. Besides the method is offered to licensees among hospitals and large medical entities worldwide, especially in Bulgaria, Romania, Ukraine, India, Kazakhstan, and African countries. The commercial agreement with technical assistance, financial and license agreements are envisaged as cooperation types. - Advantages and Innovations
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The solution is based on LC-MS/MS (Liquid chromatographic-tandem mass spectrometer) analysis of mycolic acid profiles (MAs) identified in mycobacterial cell walls. The diagnostic method has a breakthrough character due to significant improvement of the TB diagnosis process due to the following premises:
- Diagnostic time – 2 hours; currently known methods – approx. 21 days
- Diagnostics directly from the clinical material (saliva, urine, epidermis etc.), without having to proliferate the microorganism.
- Sample preparation under diagnostic conditions (about 1,5 hours) and sample analysis using a mass spectrometer
- Sensitivity of the diagnostic process at a level of 92-95% in respect of all clinically significant strains of TB bacilli and strains from the MOTT group
- Specificity of the diagnostic test at the level of 99.8% (the detectability is as low as 50 cfu/ml)
- Detection of all clinically significant strains of TB bacilli (Mycobacterium tuberculosis complex) and strains from the MOTT group (currently no other diagnostic solution available elsewhere in the world)
- Detection of mixed infections from one sample,
- Reduction of costs of the diagnostic process and treatment process – approx. 85%
- potential determination of the drug resistance profile of bacterial strains based on a simultaneous culture (72-120 h) on liquid media with the addition of an antibiotic and detection of mycolic acids using the FIA-MS/MS method to all available antibacillary drugs
- the product can be used by standard diagnostic laboratory personnel after completing short (1-2 days) training in the isolation of mycolate acids and operation of a mass spectrometer and M-TYPER software.
The M-Typer software is used to diagnose the infection and chemotaxonomy of Mycobacteria by analysing data obtained by tandem mass spectrometry in order to assess the similarity between the test samples (taken from the patient) and the samples contained in the library, obtained by the same measurement. - Stage of Development
- Already on the market
- Sustainable Development Goals
- Goal 3: Good Health and Well-being
- IPR status
- IPR granted
Partner Sought
- Expected Role of a Partner
-
The Polish company is looking for:
- investors among global pharmaceutical and diagnostic companies to buy the patent or shares of the company.
- hospitals and large medical entities to conclude license agreements. - Type and Size of Partner
- Big company
- SME 50 - 249
- SME 11-49
- Type of partnership
- Commercial agreement with technical assistance
Dissemination
- Technology keywords
- 006001002 - Care and Health Services
- Market keywords
- 005001008 - Diagnostic test products and equipment
- Sector Groups Involved
- Health
- Targeted countries
- All countries