New Generation Test for Visceral Leishmaniasis Diagnosis

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: N/A
Agency Tracking Number: 2R44AI047551-02
Amount: $0.00
Phase: Phase I
Program: SBIR
Awards Year: 2001
Solicitation Year: N/A
Solicitation Topic Code: N/A
Solicitation Number: N/A
Small Business Information
562 1ST AVE S, STE 600, SEATTLE, WA, 98104
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 () -
Business Contact
Phone: (206) 344-5821
Research Institution
DESCRIPTION (provided by applicant): Visceral leishmaniasis (VL) is a disease with high mortality in both developed and developing countries. The causative agents are the parasites Leishmania chagasi, donovani and infantum depending on geographic location. In Mediterranean countries, co-infection with HIV has become problematic and asymptomatic individuals have been shown to transmit the parasite through transfusion, in both France and Brazil. The reservoir for VL is dogs and recently U.S. foxhounds have succumbed to VL raising veterinary concerns. Tests available for early diagnosis have benefited by using the recombinant K39 antigen that is specific for active disease, but does not adequately detect asymptomatic infections. In Phase I improved diagnosis (dogs/ humans) was obtained by using K39 in combination with another recombinant antigen K26. The studies proposed here are to take advantage of this enhanced detection in a combination test for VL that would have human and veterinary applications. These studies will exploit the expertise of InBios to develop FDA approved rapid tests using a combination of Corixa Corp's K39 and K26 antigens. The studies will also benefit from a close collaboration with researchers at CDC and WRAIR and renowned consultants domestically and in developing countries and by access to their human and canine serum banks. PROPOSED COMMERCIAL APPLICATION: The proposed studies will lead to the commercialization of diagnostic tests that will aid in the early diagnosis of active and asymptomatic infections with the parasites L.donovani, chagasi, and infantum. Such test would have application in the human and veterinary fields. The worldwide market for such a test is estimated to be in excess of $10-15 million dollars based on a cost of $1.50 per test.

* Information listed above is at the time of submission. *

Agency Micro-sites

SBA logo
Department of Agriculture logo
Department of Commerce logo
Department of Defense logo
Department of Education logo
Department of Energy logo
Department of Health and Human Services logo
Department of Homeland Security logo
Department of Transportation logo
Environmental Protection Agency logo
National Aeronautics and Space Administration logo
National Science Foundation logo
US Flag An Official Website of the United States Government