MENSSANA RESEARCH INC — Department of Health and Human Services SBIR Phase I: NIAID

Description

DESCRIPTION provided by applicant The problem Active pulmonary tuberculosis TB is a leading cause of death from infectious disease throughout the world Two billion people one third of the worldandapos s population are infected with Mycobacterium tuberculosis and million died from the disease in Sputum microscopy and culture remains the mainstay of laboratory diagnosis accompanied more recently by nucleic acid amplification tests NAAT However sputum culture may require several weeksandapos incubation while NAAT is rapid but expensive An ideal diagnostic test would be sensitive and specific for active pulmonary TB non invasive suitable for use in low resource countries faster than sputum culture and less expensive than NAAT A new solution to the problem Mycobacteria manufacture unique volatile organic compounds VOCs as metabolites in vitro A sensitive breath test employing gas chromatography mass spectrometry GC MS identified VOC biomarkers of active pulmonary TB similar to VOC metabolites of M tuberculosis detected in vitro BreathLink is a new point of care breath test employing GC with surface acoustic wave detection GC SAW and it delivers results in six minutes In a multicenter study in India UK and the Philippines BreathLink identified active pulmonary TB with sensitivity and specificity The high sensitivity of the BreathLink suggests that it could be used as a andquot rule outandquot test to identify the majority without TB Experimental plans BreathLink will be validated at medical centers in India and the Philippines for its ability to andquot rule outandquot subjects who are not infected with active pulmonary TB I the Phase I unblinded study the andquot rule outandquot cutoff points will be validated by comparison to the outcomes of chest x ray and with sputum testing with microscopy culture and NAAT In the Phase II blinded study a larger study will be performed with view to confirming the efficacy of BreathLink as a screening andquot rule outandquot test for active pulmonary TB Potential impact of the research If confirmed as effective a andquot rule outandquot breath test could reduce the current high cost of finding new cases of active pulmonary TB and dramatically reduce the deaths and disabilities that TB now causes in high burden countries where health care dollars are scarce PUBLIC HEALTH RELEVANCE BreathLink is a six minute point of care breath test for volatile organic compounds VOCs that are biomarkers of active pulmonary tuberculosis TB As an accurate new andquot rule outandquot test BreathLink could reduce the current high cost of finding new cases of active pulmonary TB and dramatically reduce the deaths and disabilities that TB now causes in high burden countries where health care dollars are scarce