TB Diagnostics at the Point of Care

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$1,198,821.00
Award Year:
2013
Program:
SBIR
Phase:
Phase II
Contract:
2R44EB011274-03
Agency Tracking Number:
R44EB011274
Solicitation Year:
2013
Solicitation Topic Code:
NIBIB
Solicitation Number:
EB12-001
Small Business Information
AKONNI BIOSYSTEMS, INC.
400 Sagner Avenue, Suite 300, FREDERICK, MD, 21701-6082
Hubzone Owned:
N
Socially and Economically Disadvantaged:
N
Woman Owned:
N
Duns:
154704444
Principal Investigator:
CHRISTOPHER COONEY
(301) 698-0101
cooney@akonni.com
Business Contact:
CHRISTOPHER COONEY
(301) 698-0101
cooney@akonni.com
Research Institution:
Stub




Abstract
DESCRIPTION (provided by applicant): Of all diseases, tuberculosis (TB) represents one of, if not, the greatest health disparity between whites and minorities [1]. 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 [2]. Compounded with this disparity is the prevalence of drug-resistant mutations of TB, which have an associated 1000 polymorphisms that span 36genes, two promoter regions, and one ribosomal RNA coding region [3]. 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 1 we demonstrated feasibility of our sample preparation approach, our PCR-micorarray biochips, and prototype POC instrument. For Phase 2 we propose to expandthe 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 HEALTHRELEVANCE 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 estimated9 African-Americans, 8 Latinos, 6 Native Americans, 23 Asians, and 21 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.

* information listed above is at the time of submission.

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