Biomarker Panel for Diagnosing Pulmonary Dysfunction
Invention Novelty
The invention refers to a novel biomarker panel comprising marker genes for an earlier and more accurate diagnosis of pulmonary dysfunction after lung transplantation, in particular chronic lung allograft dysfunction (CLAD). CLAD is mainly caused by Bronchiolitis obliterans (BO) which is an inflammatory disease of the small airways leading to a scarring process and progressive airway obstruction. In 50% of all lung transplant patients, CLAD occurs as part of a rejection reaction within 5 years after transplantation, with BO being the main cause. Now, CLAD can be detected up to 12 months before clinical symptoms arise.
Value Proposition
The biomarker-based diagnostic panel addresses a critical need in the field of organ transplantation by enabling early detection of chronic lung allograft dysfunction (CLAD). CLAD affects approximately 50% of lung transplant recipients within five years after transplantation. Therefore, the technology significantly improves the outcome of lung transplantation by allowing earlier therapeutic intervention and preventing irreversible damage to lung transplants caused by CLAD.
Technology Description
The novel biomarker panel comprises a set of genes such as TM4SF18, TRGV9, TNFSF14, TRIB1, SMAD3 which were identified by gene expression profiling. More precisely, researchers from Hanover Medical School applied machine learning algorithms and successfully identified 29 out of 226 genes in varying combinations of approximately 10 genes which permit a reliable and early diagnosis of CLAD at the molecular level. By further studies with samples from transplant patients CLAD could be detected with over 90 percent certainty and up to 12 months before the first clinical symptoms occurred. This means a considerable improvement compared to the currently used diagnostic methods and enables a prediction of CLAD up to 6 months earlier before the first clinical symptoms appear. Therefore, the newly developed diagnostic approach allows the timely identification and therapy of CLAD.
Commercial Opportunity
In-licensing preferred.
Development Status
The novel biomarker panel has been successfully validated in proof-of-concept studies.
Patent Situation
EP patent application (EP 4427047A1) and US patent application (US 18,707,253) with priority of 2021 are pending.
Further Reading
Jonigk D. et al. 2015. Molecular Profiling in Lung Biopsies of Human Pulmonary Allografts to Predict Chronic Lung Allograft Dysfunction. Am J Pathol. 185(12):3178-88. doi: 10.1016/j.ajpath.2015.08.016.
Institute of Origin
