TB Diagnostics at the Point of Care

ABSTRACT This application to the Commercialization Readiness Pilot CRP Program is for commercialization assistance for our NIBIB Phase Project TB Diagnostics at the Point of Care The Phase Project is funded through an RFA that specifically addresses health disparities tuberculosis TB in the case of this project For every TB infected white person in the United States there are an estimated African Americans Latinos Native Americans Asians and Native Hawaiian Pacific Islanders with this disease Compounded with this disparity is the prevalence of drug resistant mutations of Mycobacterium tuberculosis MTB which have an associated polymorphisms that span genes two promoter regions and one ribosomal RNA coding region Current methodologies primarily available only to affluent healthcare communities still include microbial cultures which require sophisticated laboratories and weeks before a result can be determined Minorities in a low socioeconomic class with difficulties commuting and or following up with their physicians are at risk of not obtaining appropriate treatment A low cost simple to use high confidence test that detects MTB and its resistance to multiple drugs would improve TB diagnostics for these minority communities However current technologies lack the sensitivity specificity and or multiplexing capacities needed to achieve this goal We therefore propose to commercialize a drug resistance MTB test that offers the sensitivity of culture and the specificity of nucleic acid methods across a broad coverage of mutations at an affordable price For this Commercialization Readiness Pilot CRP Program we propose to become ISO certified so that we can market the test to the international community and specifically to those countries with high at risk populations PROJECT NARRATIVE This application to the Commercialization Readiness Pilot CRP Program is for commercialization assistance for a Phase Project titled TB Diagnostics at the Point of Care The Phase Project is funded through an NIH program that specifically addresses health disparities Of all diseases Tuberculosis TB represents one of if not the greatest health disparity between whites and minorities To be specific for every TB infected white person in the United States there are an estimated African Americans Latinos Native Americans Asians and Native Hawaiian Pacific Islanders with this disease The proposed project is to achieve certification that will allow us to market a test for TB drug resistance to the international community and address this health disparity PHS Rev Page Continuation Format Page