M-Typer
M-Typer is an innovative diagnostic method utilizing tandem mass spectrometry (FIA-MS/MS) to identify bacteria of the Mycobacterium genus, including Mycobacterium tuberculosis, the causative agent of tuberculosis. This technology is based on the analysis of mycolic acids—specific cell wall lipids that serve as unique biochemical markers for this group of microorganisms. As a result, M-Typer enables rapid, precise, and reliable detection of mycobacterial infections, providing an alternative to traditional diagnostic methods such as culture, PCR tests, or immunological techniques.
A key feature that sets M-Typer apart from other methods is its exceptional speed. While standard techniques, particularly microbial culture, may take anywhere from two to eight weeks to yield results, M-Typer allows for diagnosis within just two hours. This significant reduction in analysis time is crucial for infectious diseases, especially tuberculosis, where rapid pathogen detection is essential for effective treatment and preventing transmission.
The use of tandem mass spectrometry grants M-Typer exceptional sensitivity (92-95%) and specificity (100%). Its high measurement precision allows for the unequivocal identification of various Mycobacterium species, including not only Mycobacterium tuberculosis but also atypical mycobacteria, which is critical for diagnosing opportunistic infections in immunocompromised patients. Moreover, this method enables the detection of mixed infections—an advantage over other diagnostic techniques that often cannot simultaneously identify multiple pathogens.
M-Typer is designed to be compatible with existing laboratory infrastructure, offering flexibility in integration with different mass spectrometry systems. The analysis-controlling software is available as a web-based application, allowing remote access and data management from any location without requiring local installation. The system supports operations on Sciex-brand spectrometers, requiring integration with Analyst® Sciex software, as well as Shimadzu devices, significantly expanding implementation possibilities in diagnostic laboratories. The entire diagnostic procedure has been optimized for laboratory workflow efficiency—both mycolic acid isolation and their analysis via mass spectrometry follow strictly defined, validated protocols, ensuring maximum result reproducibility and high diagnostic quality.
The innovative nature of M-Typer technology has been confirmed by CE/IVD certification, indicating that it meets the rigorous European standards for in vitro diagnostic medical devices. This certification attests to both the test’s safety and efficacy, allowing its introduction to the diagnostic market within the European Union and other regions that recognize CE standards. Additionally, the technology holds a Free Sale Certificate issued by the Office for Registration of Medicinal Products (URPL), paving the way for M-Typer’s international distribution beyond Europe.
The uniqueness and pioneering nature of the FIA-MS/MS method in mycobacterial diagnostics have been secured through international patent EP3978617B1. This technology ensures outstanding precision and sensitivity in Mycobacterium identification, making it one of the most advanced methods available on the market. Patent protection covers key global markets, ensuring a competitive edge and serving as a crucial asset in the commercialization and large-scale implementation of the test.
DiMedical, the company responsible for the development and deployment of M-Typer, operates a fully equipped research and development laboratory, enabling further method optimization and validation studies across various clinical environments. The company is actively working to scale the technology and enhance its availability in the diagnostic market. As part of its development strategy, DiMedical focuses on expanding research infrastructure and implementing innovative technological solutions to optimize the analysis process further. A key element of these efforts is software development and the implementation of new data processing algorithms, allowing for even faster and more precise diagnostics. To achieve this, the company plans to hire software specialists and bioinformatics experts who will refine the system, integrate it with modern databases, and introduce advanced statistical analysis and machine learning methods.
M-Typer represents one of the most advanced diagnostic solutions for tuberculosis and other diseases caused by Mycobacterium. With its unique biochemical analysis approach, CE certification, patent protection, and support from an advanced research infrastructure, this technology has the potential to become the new global standard in mycobacterial diagnostics.