New Generation Test for Visceral Leishmaniasis Diagnosis
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
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.
Small Business Information at Submission:
Principal Investigator:Syamal Raychaudhuri
INBIOS INTERNATIONAL, INC.
562 1ST AVE S, STE 600 SEATTLE, WA 98104
Number of Employees: