Sedia Biosciences received a $195,490 Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) to develop a Rapid HIV-1 Incidence Assay that will determine recency of HIV-1 infection in 20 minutes from less than a drop of blood.

The National Institute of Allergy and Infectious Diseases provided the funding for Phase I of the proposed project to establish feasibility of the assay. Depending on the outcome of the studies, an additional Phase II funding of up to $1 million through the SBIR program may be available to commercialize the assay.

According to Sedia, the assay would enable epidemiologists to estimate HIV-1 incidence rates without relying on laboratory-based assays or longitudinal cohort studies. Ultimately, it could provide clinicians with additional disease state data to improve patient management by identifying early infections, which are at highest risk of transmission. The company said treatment of such early infections provides the greatest opportunity to reduce viral levels before viral reservoirs become established. Since viruses established in those reservoirs are particularly resistant to most antiretroviral therapies, this is of particular interest to the researchers.

The rapid HIV-1 assay is from U.S. Centers for Disease Control and Prevention (CDC) licensed technology, based in part on Sedia’s HIV-1 LAg-Avidity EIA assay, which is also used for HIV-1 incidence rate estimation and first developed and commercialized by Sedia in collaboration with the CDC.

“There was considerable excitement among other scientists over the prospect of having a rapid HIV-1 incidence assay that’s simple, usable in the field and doesn’t require laboratory support,” said Paul Smith, director of product support and technical services at Sedia. “Some delegates characterized the assay as ‘a game-changer.’ This will expand the ability of programs in developing countries to obtain this important data about the patient, and the state of the epidemic.”

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