P2*
Pan-Tuberculosis Signature
Prof. Jan Rybniker, University of Cologne; Dr Isabelle Suarez, University of Cologne; Dr Sebastian Theobald, University of Cologne; Dr Thomas Ulas, University of Bonn; Dr Marc Beyer, University of Bonn; Dr Kilian Dahm, German Center for Neurodegenerative Diseases
PROvendis GmbH
Challenge
Mycobacterium tuberculosis (Mtb), the pathogen that causes tuberculosis (TB), continues to contribute significantly to mortality and morbidity worldwide. In 2022 alone, Mtb caused 1.3 million deaths and 10 million new infections, despite extensive global efforts to combat the disease (TB). A better understanding of the pathogenesis of the disease and how Mtb modulates the human immune response is critical to improving our diagnostic, prophylactic, and therapeutic efforts against TB.
Technology
In recent years, several gene expression signatures based on transcriptomic whole blood data sets have been published as simple diagnostic biomarkers or for monitoring disease progression, particularly for pulmonary TB (PTB). Despite the development of a commercial prototype test, no consensus has been reached on an optimal and minimal diagnostic gene set. The performance of this prototype test is not optimal and is therefore not suitable for widespread clinical use. Thus, the present invention describes a new gene signature that was created using a transcriptomic whole blood dataset from patients with extrapulmonary tuberculosis.
Twenty-five percent of all tuberculosis cases are extrapulmonary tuberculosis (EPTB), which is characterized by its heterologous clinical picture. This makes the diagnosis of EPTB difficult with conventional clinical tests and often requires invasive methods. The new gene signature consists of a total of 15 differentially regulated genes, only 5 of which overlap with published gene signatures. To our knowledge, this signature is the first signature developed from patients with EPTB. Furthermore, the new gene signature shows high specificity, allowing tuberculosis infection to be distinguished from other diseases. In addition, the signature is capable of detecting not only EPTB, but all forms of TB (including pulmonary TB). Here too, the signature is more efficient than previously published signatures; it is a Pan-TB signature.
Commercial Opportunity
The technology enables a highly sensitive differential diagnosis of tuberculosis. The technology is ready for licensing.
Development Status
The invention has been developed to TRL 5.
Patent Situation
A priority patent application has been recently filed recently.
Further Reading
Theobald, S.J., Dahm, K., Lange, D. et al. Deep immune profiling delineates hallmarks of disease heterogeneity in extrapulmonary tuberculosis. Nat Commun 16, 9662 (2025).
doi.org/10.1038/s41467-025-65561-x
