An innovative diagnostic technology developed by DiMedical, using tandem mass spectrometry to identify bacteria of the genus Mycobacterium — including mycobacteria of the Mycobacterium tuberculosis complex and non-tuberculous mycobacteria (NTM).
The technology is based on the analysis of mycolic acids — specific lipids of the mycobacterial cell wall that serve as a characteristic biochemical marker for this group of microorganisms. The solution was created for diagnostic laboratories, reference centres, scientific institutions and implementation partners.
M-Typer uses mycolic acids as markers for the presence and differentiation of bacteria of the genus Mycobacterium.
Mycolic acids are long-chain fatty acids that constitute a key structural component of the mycobacterial cell wall. Their profile differs between species and groups of mycobacteria, which is why it can be used for the identification and differentiation of mycobacteria.
CELL WALL · MYCOLIC ACIDS
01
Isolation of mycolic acids
Extraction of the characteristic cell-wall lipids of mycobacteria from the tested material.
02
FIA-MS/MS analysis
Flow injection analysis coupled with tandem mass spectrometry.
03
Profile interpretation
Analysis of the result using dedicated M-Typer Software.
The technology can support the detection of infections caused by mycobacteria of the genus Mycobacterium, including the Mycobacterium tuberculosis complex and non-tuberculous mycobacteria.
PROCESS
How does M-Typer work?
The process consists of five key stages — from sample preparation to result interpretation.
WORKFLOW FIA-MS/MS
1Sample preparation
2Isolation of mycolic acids
3FIA-MS/MS analysis
4Mycolic acid profiling
5Result interpretation
1
Sample preparation
Biological or culture-derived material is prepared for mycolic acid isolation. In the case of sputum, the procedure includes prior preparation and liquefaction of the sample.
2
Isolation of mycolic acids
Using the M-Typer Reagent Kit: washing, alkaline hydrolysis, neutralisation, liquid–liquid extraction and preparation of the extract for analysis.
3
FIA-MS/MS analysis
The extract is analysed by flow injection analysis with tandem mass spectrometry, monitoring selected MRM transitions characteristic of mycolic acids.
4
Mycolic acid profiling
The system generates an analytical profile of the mycolic acids present in the tested sample.
5
Result interpretation
The profile is interpreted using dedicated M-Typer Software, which supports the analysis of the obtained result.
BENEFITS
Key benefits of the technology
A modern solution for laboratories involved in mycobacterial diagnostics.
RAPID MYCOLIC ACID PROFILE ANALYSIS WITH FIA-MS/MS
SUPPORT FOR DETECTING MYCOBACTERIUM MYCOBACTERIA OF THE GENUS
ABILITY TO DIFFERENTIATE MTBC AND NTM
STABLE MARKERS OF THE MYCOBACTERIAL CELL WALL
WORKFLOW FOR REFERENCE LABORATORIES
COMPATIBILITY WITH LC-MS/MS INFRASTRUCTURE
SUITABILITY FOR HIGH-THROUGHPUT WORKFLOWS
A DEDICATED REAGENT KIT
INTERPRETATION SUPPORTED BY M-TYPER SOFTWARE
TECHNOLOGY DEVELOPED BY DIMEDICAL
INFRASTRUCTURE
Instrument compatibility
M-Typer has been developed for laboratories equipped with high-sensitivity triple quadrupole tandem mass spectrometers operating in ESI ionisation mode and enabling FIA-MS/MS analysis with MRM transition monitoring.
SCIEX QTRAP® 6500
Triple quadrupole tandem mass spectrometer
Shimadzu LCMS-8050
Triple quadrupole tandem mass spectrometer
Equivalent systems
Other LC-MS/MS systems meeting the analytical requirements of the method
SCIEX QTRAP® 6500
SHIMADZU LCMS-8050
LABORATORY
If a laboratory has a triple quadrupole LC-MS/MS system, M-Typer may provide an opportunity to extend its diagnostic portfolio with mycolic acid profile analysis for bacteria of the genus Mycobacterium.
PRODUCT
M-Typer Reagent Kit
An in vitro diagnostic medical device intended for the isolation of mycolic acids from biological or culture-derived material for subsequent FIA-MS/MS analysis. The kit supports the sample preparation stage and enables the generation of an extract containing mycolic acids.
M-TYPER REAGENT KIT
COMPLETE REAGENT KIT
The M-Typer Reagent Kit contains all reagents required for the isolation of mycolic acids from biological or culture-derived material. It enables 100 isolations and is an integral part of the M-Typer workflow before FIA-MS/MS analysis.
Used by qualified laboratory personnel in accordance with the current Instructions for Use.
PRODUCT INFORMATION
PRODUCT NAME
M-Typer Reagent Kit
REFERENCE NUMBER
MT-KIT-001
STATUS
In vitro diagnostic medical device
KIT COMPOSITION
Set 1 + Set 2
INTENDED USE
Isolation of mycolic acids before FIA-MS/MS analysis
NUMBER OF ANALYSES
100 mycolic acid isolations
MANUFACTURER
Centrum Medycyny Klinicznej DiMedical Sp. z o.o.
REAGENT WORKFLOW
1. Washing of the material
2. Alkaline hydrolysis
3. Neutralisation
4. Liquid–liquid extraction
5. Preparation of the extract for FIA-MS/MS analysis
The kit is part of the complete M-Typer workflow and should be used by qualified laboratory personnel in accordance with the current Instructions for Use.
DOWNLOADS
Documents and downloads
Current documentation for M-Typer technology and the M-Typer Reagent Kit — Instructions for Use and SDS/MSDS safety data sheets. Before starting work with the kit, read the current Instructions for Use and the safety data sheets. All laboratory activities should be performed by qualified personnel.
Watch the video presenting the main stages of working with the M-Typer Reagent Kit and preparing the sample for FIA-MS/MS analysis.
The video material is for auxiliary and training purposes. It does not replace the current Instructions for Use or applicable laboratory procedures. Before using the kit, read the full product documentation and the SDS/MSDS safety data sheets.
SCIENCE
Scientific publications
M-Typer technology was developed based on research and development work on the use of mycolic acids as diagnostic markers for bacteria of the genus Mycobacterium.
PUBLICATIONS ON M-TYPER
Detection and accurate identification of Mycobacterium species by flow injection tandem mass spectrometry (FIA-MS/MS) analysis of mycolic acidsScientific Reports, 2025
nature.com/articles/s41598-025-96867-x →
Towards the elimination of tuberculosis: advances in diagnostics, treatment, and vaccinationEuropean Journal of Medical Research, 2026
doi.org/10.1186/s40001-026-04532-4 →
PUBLICATIONS SUPPORTING THE SCIENTIFIC BASIS OF THE METHOD
Quantification of mycolic acids in different mycobacterial species by standard addition method through liquid chromatography mass spectrometryJournal of Chromatography B, 2024
sciencedirect.com — S1570023224003064 →
Rapid method for Mycobacterium tuberculosis identification using electrospray ionization tandem mass spectrometry analysis of mycolic acidsDiagnostic Microbiology and Infectious Disease, 2013
sciencedirect.com — S073288931300196X →
Untargeted and Targeted LC-MS–Based Lipidomic Profiling Revealed a Potential Biomarker Panel to Distinguish Clinical Isolates of M. tuberculosis From Nontuberculous M. kansasiiPulmonary Medicine, 2026
onlinelibrary.wiley.com — 10.1155/pm/5535650 →
Enhanced diagnosis accuracy of tuberculous meningitis using mycolic and tuberculostearic acid via advanced mass spectrometryJournal of the Neurological Sciences
doi.org/10.1016/j.jns.2025.123748 →
Scientific publications confirm that mycolic acid analysis can be a valuable approach for the identification and differentiation of mycobacteria of the genus Mycobacterium. M-Typer develops this concept into a rapid, scalable workflow based on FIA-MS/MS, a reagent kit and dedicated interpretative software.
REGULATORY STATUS
Certification, patent protection and implementation potential
M-Typer technology was developed by DiMedical as an innovative solution in the field of mycobacteriology diagnostics. It is being further developed with a view to validation, scale-up and implementation in reference and diagnostic laboratories.
CE / IVDIn vitro diagnostic device certification
ISO 13485Certified quality management system
EP3978617B1European patent protecting the unique character of the solution
B+RDevelopment, validation and international cooperation
The solution is CE/IVD certified, is developed within a certified quality management system compliant with ISO 13485, and its unique character is protected by European patent EP3978617B1. DiMedical is actively working to develop the technology, expand international cooperation and build partnerships with laboratories, scientific institutions and distributors.
PARTNERSHIP
Partner with us
DiMedical is open to collaboration with diagnostic laboratories, reference centres, scientific institutions, clinical partners, distributors and organisations interested in implementing or validating M-Typer technology.
Evaluation of M-Typer technology under laboratory conditions
Participation in validation and multicentre projects
Implementation of the method in reference laboratories
Distribution of the technology in international markets
Scientific and clinical collaboration in tuberculosis and mycobacteriosis diagnostics
Development of new FIA-MS/MS applications in mycobacterial diagnostics
We support partners in organising the implementation process, preparing the reagent workflow, setting up the analytical configuration, interpreting results and planning further validation studies.
AUDIENCE
Who is M-Typer for?
REFERENCE LABORATORIES
LABORATORIES WITH LC-MS/MS INSTRUMENTATION
TUBERCULOSIS DIAGNOSTIC CENTRES
INSTITUTIONS INVESTIGATING NTM
SCIENTIFIC INSTITUTES
CLINICAL PARTNERS
DISTRIBUTORS OF DIAGNOSTIC PRODUCTS
MARKETS WITH A HIGH TUBERCULOSIS BURDEN
DIMEDICAL
Why DiMedical?
We combine laboratory experience, research and development capabilities and practical expertise in mycobacteriological diagnostics. M-Typer was developed in response to the need for faster and more advanced diagnostics of infections caused by mycobacteria of the genus Mycobacterium.
PROPRIETARY TECHNOLOGY DEVELOPED BY DIMEDICAL
EXPERIENCE IN DIAGNOSTICS AND R&D
SPECIALISATION IN MYCOBACTERIAL DIAGNOSTICS
WORKFLOW: REAGENTS, LC-MS/MS AND SOFTWARE
READINESS FOR INTERNATIONAL COLLABORATION
OPENNESS TO VALIDATION AND IMPLEMENTATION PROJECTS
Important information
A result obtained using M-Typer technology should not constitute the sole basis for a clinical diagnosis. It should be interpreted together with other laboratory test results and the patient’s clinical presentation.
The technology is intended for use by qualified laboratory personnel in accordance with the current Instructions for Use and applicable safety procedures.
