Development and Commercialization of an Innovative Rapid HIV-1 Incidence Assay

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DESCRIPTION (provided by applicant): The objective of this project is to develop a commercially viable point of care Rapid HIV-1 Incidence Assay and establish its suitability for determination of recency of HIV-1 infection in whole blood, plasma, serum specimens for epidemiological, research and surveillance purposes. It is further intended to determine the feasibility of the application of the assay to dried blood spot and oral fluid specimens. Potential development of the assay into a combined incidence/diagnostic assay including applicable regulatory submissions is not intended until Phase II of the project. Recent advances in development of accurate assays for distinguishing recent from long-term HIV infections have been limited to complex laboratory based assays. However, many resource constrained countries and laboratories need to be able to estimate HIV incidence rates in populations, but do not have ready access to full laboratory facilities. The proposed Rapid HIV-1 Incidence Assay, once established as suitable for population surveillance use, may also eventually be useful for providing tailored therapeutic, counseling and contact follow-up of individuals at the point of care, coincident with diagnosis. The assay will be developed based on a combination of rapid lateral flow immunochromatography test technology proprietary to Sedia Biosciences and rapid incidence test technology developed and licensed from the U.S. Centers for Disease Control (CDC). The project is of significant relevance to the CDC, as the CDC oversees a number of domestic and international programs to monitor the HIV epidemic in the U.S. and around the world, including in countries that have limited laboratory resources. The proposed assay may be used as well by researchers, epidemiologists, other governmental and private public health organizations and vaccine trial program managers to understand and target the HIV epidemic, as well as assess the effectiveness of intervention programs and identify "hot spots" of infections. Sedia intends to collaborate with the domestic and international branches of the CDC's HIV program on this project by developing the assay according to CDC needs and specifications, and evaluate the resulting assay in cooperation with the CDC using archived cross-sectional serum specimens of known recency to determine the accuracy of the test. Sedia further intends to channel assay prototypes through the CEPHIA (Consortium for the Evaluation of Performance of HIV Incidence Assays) program to evaluate HIV incidence assays, before expanding testing to multiple outside investigators in Phase II of the project.