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

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 DESCRIPTION (provided by applicant): The objective of this Phase II project is to develop a commercially viable point of care Rapid HIV-1 Incidence Assay, the Asanté Rapid HIV-1 Recency 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 from liquid blood, serum or plasma for the estimation of HIV incidence rates. It is further intended to extend the application of the Assay to dried blood spot and oral fluid specimens. In addition, we intend to develop the Assay for a second intended use as a test to identify (either screening or confirmation) and determine recency of infection of specimens in individuals. For HIV incidence application, assays to estimate HIV incidence have been limited to complex laboratory based assays. However, many resource constrained areas need to be able to estimate HIV incidence rates in populations, yet do not have ready access to full laboratory facilities. The Assay, once established as suitable for population surveillance use, we believe, will also eventually be useful for providing for a second intended use: tailored therapeutic, counseling and contact follow-up of individuals at the point of care, coincident with diagnosis. Individual clinical use (with regulatory approval) will identify recently infected individuals and aggressively manage their treatment and followup. Intervention in early infections is important to begin treatment before virus reservoirs are established in the body rendering the HIV infection "incurable", reduce transmission rates by aggressively treating persons with such early infections which have the highest viral load and therefore the greatest risk of infection to sexual partners, and enable prioritization of contact tracing. The assay was developed in Phase I 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 Assay will be scaled-up as a commercial product and validated and prepared for subsequent clinical trials during this phase. 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. 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 CDC on this project by developing the assay according to CDC needs and specifications, but also by working with other stakeholders with a vested interest in the development of such assay such as WHO and CEPHIA (Consortium for the Evaluation and Performance of HIV Incidence Assays). CEPHIA provides a unique resource to independently evaluate HIV incidence assays and will add further credibility to the performance and utility of the assay.