The malfunction of the immune system is the cause of around 80% of chronic diseases. This includes malfunctioning immune activation in the tissue, which leads to inflammatory diseases and severe organ damage. Relevant diseases caused by a dysregulated immune response are:
• Chronic inflammation and diseases such as Crohn's disease, ulcerative colitis, and multiple sclerosis
• Chronic infections (viral hepatitis, tuberculosis, etc.)
• Cancer (in the context of chronic inflammation)
Significant evidence has been accumulated that there is a link between chronic inflammation and tissue damage especially the role of CD8 T cell auto-aggression: Immune system attacks organs upon reprogramming of CD 8 T cells to become autoaggressive (Dudek et al. & Pfister et al. Nature 2021).
Recently, it has been demonstrated that auto-aggressive CD8 T cells are also abundantly present in inflammatory tissue of patients with Crohn disease and Colitis ulcerosa (Fackler et al. Manuscript submitted). Today inflammatory mediated diseases are diagnosed at the earliest upon manifestation of the illness and, therefore, therapy is initiated at an advanced stage of disease. Exosome-based immune diagnostic, exID, in combination with artificial intelligence, exAI, will introduce a breakthrough change.
To date, there is no approved diagnostic method to measure the damaging activity of immune cells in tissue or organs. Diagnostics in personalized medicine currently focus on PCR and RNA/DNA sequencing as well as immunohistochemistry on diseased tissue. These analyzes measure individual proteins or, in the case of PCR and sequencing, genetic or transcriptional changes. The detection of misdirected immune activation in the tissue is not possible and, therefore, the relationships between the signaling pathways involved and their regulation are not recorded.
Our approach to establish a new dimension in diagnostics involves two paradigm shifts:
1) exID enables the non-invasive early detection of the organ-damaging process instead of the previous diagnosis of the manifestation of organ damage
2) exID develops and uses an AI-powered platform (exAI) to identify immune signatures in exosomes that are released by immune cells in tissue and measured in blood based on our proprietary ELAEXIA® technology for the highly specific detection and purification of exosomes.
exID makes immune-mediated organ damage directly measurable without the disadvantages of a biopsy (invasive procedure, sampling error, difficult to standardize detection of molecular markers) and in addition to imaging.
The breakthrough innovation of exID and exAI is manifested in the following points:
• Technology innovation based on for the selective analysis of exosomes from peripheral blood for the downstream mass spectrometric AI-assisted analysis to detect relevant immune signatures
• Early detection of organ-damaging processes as a new dimension of diagnostics
• Future development of new drugs based on targets identified by exID
• Future monitoring of therapy success through exID technology
Early diagnosis of malfunctioning immune cell-based damage opens the possibility of targeted intervention to prevent disease-relevant organ damage.
