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 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.
