R&D of a Rapid, Simple HTLV Diagnostic Assay

The objective of the proposed research is the development of a low cost, rapid, simple test todetect infection with Human T-cell Lymphotropic Virus Types I and II. These viruses are associated witha fatal condition called Adult T-cell Leukemia and a debilitating disorder termed Tropical SpasticParaparesis. The proposed test will utilize and modify the Company's INSTI immunodiagnostic formatwhich has already provided the basis of a 30 second HIV-1/HIV-2 test. Significant technologicalinnovations proposed include the ability to use whole blood and visual differentiation between IgG, IgMand IgA classes of antibodies. The INSTI-HTLV test is expected to take less than 1 minute and 2 stepsto perform compared to the several hours and 10 steps required by currently available ELISA andagglutination products. The test will address a major market need for field tests in high incidence anddeveloping countries. It will also provide a major advance for the routine screening of pregnant mothersand other point of care testing in industrialized countries.