Assays that determine recency of HIV infections are used by epidemiologists, researchers and public health scientists to estimate and monitor the rate of new HIV infections in populations. Such data is useful for identifying new outbreaks of infection and infection “hot spots”, evaluating effectiveness of intervention efforts and evaluating HIV vaccine candidates.
The Sedia™ HIV-1 Limiting Antigen-Avidity EIA is based on technology developed by the U.S. Centers for Disease Control and Prevention (CDC), where the first research assays were made. The assay is being developed and commercialized by Sedia in cooperation with the CDC. Preliminary data generated have demonstrated that antibody avidity is less affected by physiological, genetic and viral characteristics than other antibody indicators used for recency determination. Some of this data will be presented next week at the XIX International AIDS Conference in Washington D.C. by third party researchers. Sedia will also be exhibiting the new assay and its other HIV technologies at the Conference.
“We are pleased to have received this highly competitive grant from NIAID,” stated Dr. Ronald Mink, Sedia’s President and Chief Science Officer. “Early evaluations of the Sedia HIV-1 Limiting Antigen Avidity EIA by the CDC have already surpassed expectations in estimating recent infections. We are excited to be expanding these studies in cooperation with the CDC and other scientists around the world to determine how best to use the assay in public health programs worldwide.” Additional information about the assay can be found at http://www.hivincidence.com.
Sedia anticipates commercializing the assay initially as a research use only product, and to subsequently seek FDA approval for the assay for diagnostic use. The Phase I SBIR grant is for $194,000, and permits the company to apply for subsequent funding of up to $1 Million in Phase II to support full commercialization.