Sedia Biosciences Corporation announced today that it has received a Notice of Award from the National Institutes of Health (NIH) for a Small Business Innovation Research (SBIR) Grant to develop a Rapid HIV-1 Incidence (or Recency) Assay that will determine recency of HIV-1 infection in as little as 20 minutes from less than a single drop of blood. Initially, the assay would enable epidemiologists to estimate HIV-1 incidence rates without relying on laboratory based assays or longitudinal cohort studies. However, it could ultimately provide clinicians with additional disease state data to improve patient management by identifying early infections which are at highest risk of transmission. Furthermore, treatment of such early infections provides the greatest opportunity to reduce viral levels before viral reservoirs become established. The ability to intervene prior to establishment of viral reservoirs is of particular interest to researchers working to develop a cure for HIV infections, since virus established in those reservoirs are particularly resistant to most antiretroviral therapies.
Funding is provided by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health for Phase I of the proposed project in the amount of $195,490 to establish feasibility of the assay. Additional Phase II funding of up to $1.0 Million through the SBIR program funding may be available to commercialize the assay depending on the outcome of the Phase I studies.
According to Dr. Ronald W. Mink, President and Chief Science Officer of Sedia Biosciences and the Principal Investigator on the grant, “We are excited to receive the support from NIH which will enable us to aggressively move forward on this new assay, which will build on Sedia’s expertise in HIV assays to measure recency of infection and estimate incidence. We have already generated very encouraging data on the performance of this assay, which was presented at the recent International AIDS Conference in Melbourne Australia.” Paul Smith, Sedia’s Director of Product Support and Technical Services, who presented the data at the AIDS Conference, said, “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. 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.” The rapid HIV-1 assay for measuring recency of infection is based on 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.