Research Project
9347766
ABSTRACT This application to the Commercialization Readiness Pilot (CRP) Program is for commercialization assistance for our NIBIB Phase 2 Project ? TB Diagnostics at the Point of Care. The Phase 2 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 9 African-Americans, 8 Latinos, 6 Native Americans, 23 Asians, and 21 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 1000 polymorphisms that span 36 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 13485 certified so that we can market the test to the international community, and specifically to those countries with high at-risk populations.
