AKONNI BIOSYSTEMS INC — Department of Health and Human Services SBIR Phase II: NIBIB

Description

DESCRIPTION provided by applicant Of all diseases tuberculosis TB represents one of if not the greatest health disparity between whites and minorities 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 TB which have an associated polymorphisms that span genes two promoter regions and one ribosomal RNA coding region Current methodologies available primarily to affluent healthcare communities utilize microbial cultures which require sophisticated laboratories and weeks before a result can be determined Difficulties for minorities in a low socioeconomic class to commute and or follow up with their physicians can result in a lack of appropriate treatment A low cost simple and rapid point of care POC test that detects TB and its resistance to first line drugs isoniazid rifampin ethambutol and pyrazinamide would improve TB diagnostics for these minority communities However current technologies lack sensitivity specificity and or multiplexing capacity to achieve this goal We therefore propose to develop a POC device that offers the sensitivity of culture methods specificity of nucleic acid methods and a broad coverage of mutations To accomplish this we will advance our TruArray platform hemispherical porous gel drop microarrays for TB diagnostics using on chip PCR and our existing MDR TB PCR microarray biochips During Phase we demonstrated feasibility of our sample preparation approach our PCR micorarray biochips and prototype POC instrument For Phase we propose to expand the coverage of our test to include additional mutations that confer resistance to all first line drugs integrate this test onto our POC instrument and translae this system to Laboratorios Medicos Especializados in Juarez Mexico PUBLIC HEALTH RELEVANCE 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 develop a point of care device for identifying drug resistant strains of Tuberculosis that can be widely disseminated to minority populations