Each latent TB case has a 5-15% probability to develop into active TB disease, with the risk being highly increased among immunocompromised individuals. Thus, latent TB infection represents a very large reservoir of potentially-contagious active TB cases, especially in the context of conditions such as immunosuppressive medication during transplantation, treatment of chronic inflammatory diseases like rheumatoid arthritis and Crohn’s disease, or HIV infection. As there is no good vaccine available for TB, the only weapon against this highly-contagious and life-threatening bacterial disease is early diagnosis and therapy.
Diagnosing TB, however, remains a major challenge. Two highly pressing needs in TB screening and diagnosis right now are (1) a diagnostic test that can confirm TB infection with very high accuracy and (2) a diagnostic test that can discriminate or triage patients with active disease from latent TB infections. Shortcomings of the current TB screening process still lead to patients having to go through a set of costly and laborious clinical tests and potentially endure risky procedures or take medication unnecessarily. There is no gold standard to solve either one of the two key problems - accurately detect and triage - consistently.
Lophius Biosciences is addressing this important medical need by developing a blood-based, multi-marker TB screening test with the purpose to deliver a significant improvement in TB infection detection over the existing approaches and to disrupt the field by differentiating between active TB disease and latent TB infection. The test is based on the same key capabilities and expertise that the Company has used successfully in other infectious disease markets – the ability to accurately mimic and analyze immune reactions in an in vitro diagnostic setting by detecting biomarkers produced by immune cells following pathogen-specific stimulation.