MtLDL detection to diagnose childhood tuberculosis

Project SummaryChildhood TB is estimated to contributeof the disease burden in high burden settingswith approximately a million cases per year inworldwideExisting gold standard diagnostic culture tools fail to confirm TB in most childrenwho typically have low bacterial counts and cannot produce sputumMore sensitive and child friendly diagnostic tools are urgently needed to diagnose TB in childrenChronus Pharmaceuticals proposes to develop a robustminimally invasiveserum based diagnostic tool that detects active TB in childrenOur technology is based on the detection of pathogen modifications of a host lipoprotein MtLDLusing a low cost and easy to use antibody diagnostic technologyenzyme linked immunosorbent assayELISAThe ELISA technology format will be commercialized for MtLDL as a test for childhood TB disease to help identify the approximately one million new pediatric cases each year and prevent the more thanpediatric deaths that occur each year from TBWe will demonstrate that antibody based detection of MtLDL in patient blood will provide specific detection of TB disease in both HIVand HIVchildrenAimfocuses on establishing independence of MtLDL detection from possible interfering substancesAimis to quantitate patient MtLDL levels that occur with active TB diseaseUpon completion of Phase Iwe will undertake GMP compliant production of kits for expanded clinical testing to validate the assayChronus Pharmaceuticals will utilize an antibody diagnostic OEM to produce kitsWe will partner with the NIH Clinical trials network researchersIMPAACT ACTGwho provided validation samples used in this proposal to distribute and sell diagnostic kits to clinicians in pediatric TB endemic countries In this Phase I STTRChronus Pharmaceuticals plans to develop a robustminimally invasiveserum based diagnostic tool that detects active TB in children