Tuberculosis: Closing the diagnostic gap
At the end of last year, researchers from Fraunhofer ITMP and the Tropical Institute at LMU Klinikum launched the "DisTB" study(Discovery of novel biomarkers for the diagnosis of TB disease) at the Fraunhofer ITMP site for Immunology, Infection and Pandemic Research IIP in Penzberg/Munich as part of the strategic collaboration with Roche that has been in place since 2022. The aim of the study is to identify new, highly sensitive and specific biomarkers for the diagnosis of tuberculosis disease that are not based on sputum, but on blood, urine or saliva samples. In addition, a platform for the collection of samples for the discovery and verification of further diagnostic markers is to be created. Blood-based test methods such as the interferon-gamma release assay, IGRA for short, have already existed for several years, but it is not possible to differentiate between active tuberculosis disease and a latent tuberculosis infection or previous contact with the bacterium.
"Beyond sputum": New biomarkers for tuberculosis diagnostics
Around a quarter of the world's population is latently infected with tuberculosis pathogens, 10.6 million people contract tuberculosis every year and around 1.3 million die from it. According to estimates by the World Health Organization (WHO), 40 percent of tuberculosis cases go undiagnosed or unreported. In children, the rate is significantly higher at over 70 percent. Although the pathogen, the Mycobacterium tuberculosis complex, has been known for over 140 years, diagnosing the infectious disease remains a challenge. It requires a complex infrastructure and this is not accessible to many affected people. In addition, common tuberculosis tests are based on microbial detection in sputum, the secretion of the deep respiratory tract. These samples are difficult to obtain in children or immunocompromised people, for example, and it is not always possible to reliably detect the disease, especially as infections outside the respiratory tract also occur. In addition to the diagnostics toolbox, the Fraunhofer ITMP, the LMU Klinikum München and Roche are now researching new solutions for patient-oriented tuberculosis diagnostics in their second joint cooperation project in order to facilitate access for those affected, particularly those from low- and middle-income countries.
Thanks to its combined strengths in pharmaceuticals, diagnostics and health IT, Roche is a pioneer and innovator in personalized medicine. As the world's leading manufacturer of diagnostic analysis systems for in-vitro diagnostics, the company contributes its expertise in the field of molecular protein, IHC and nucleic acid tests to the research cooperation with Fraunhofer and the LMU Klinikum at the Munich/Penzberg site. It is important to Roche to develop medical solutions to improve people's health and quality of life.
The LMU Klinikum München has decades of experience in the development of new diagnostics and drugs in the field of tuberculosis. With a worldwide research network and participation in global consortia and projects, the International Clinical Trials Unit of the Tropical Institute at LMU Klinikum has developed into a global player in tuberculosis research. As part of the cooperation, the Tropical Institute at the LMU Klinikum is currently looking for test subjects in the greater Munich area (see further information).
The newly founded Fraunhofer-ITMP site for Immunology, Infection and Pandemic Research IIP focuses on the translational interface between academic research and industry and establishes the latest technologies for the development of new infection diagnostics.
"The aim of the Fraunhofer-Gesellschaft is to contribute to the translation of research results into practice through applied research. Collaboration with university partners and industry is an essential instrument for this. The cooperation between Roche, the LMU Klinikum and the Fraunhofer ITMP will develop concrete solutions for tuberculosis diagnostics and help to further strengthen the already close partnership between the institutions".
Prof. Dr. Dr. Gerd Geißlinger, Director of the Fraunhofer Institute for Translational Medicine and Pharmacology ITMP Frankfurt am Main
Director of the Institute for Clinical Pharmacology, University Hospital Frankfurt am Main
"We at Roche have recognized the problem of diagnosing tuberculosis and therefore want to address the issue. We are convinced that, in collaboration with experts in the field, significant progress can be made in the diagnosis of this serious disease. If we can get the chronic pandemic under control in this way, it would have a significant positive impact on people's health worldwide."
Dr. Elke Glasmacher, Global Head of Discovery Sciences in Diagnostics, Roche in Penzberg
"A diagnosis of tuberculosis that is close to the patient and available on the same day is an indispensable prerequisite for achieving the goal of eliminating tuberculosis. We are very pleased that a large company like Roche is taking on this problem".
Professor Dr. med. Michael Hoelscher, Site Director, Fraunhofer ITMP Site IIP in Penzberg/Munich
Director of the Department of Infectious Diseases and Tropical Medicine, LMU Klinikum München
Further information on the Fraunhofer Site for Immunology, Infection and Pandemic Research (IIP):
