Phase I Grant to develop a rapid assay version of Sedia’s HIV-1 LAg-Avidity EIA could expand HIV incidence testing in resource constrained settings and provide additional patient information for improved case management.
PORTLAND, Ore.–(BUSINESS WIRE)–August 18, 2014–
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.
Research reported in this press release was supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under award number R43AI114365. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
About Sedia Biosciences Corporation:
Sedia Biosciences Corporation (www.sediabio.com) is a U.S.-based healthcare company focused on the development and commercialization of novel in vitro diagnostic and epidemiological tests including the Sedia™ BED HIV-1 Incidence EIA and LAg-Avidity EIA. The company is dedicated to advancing access to medical care by developing innovative diagnostic and monitoring products that enable more cost effective and expanded testing for infectious diseases and other conditions. Based in Portland, Oregon, Sedia develops, manufactures, licenses and sells in vitro diagnostic and epidemiological tests as well as specimen collection devices.
Statements in this press release that are not historical facts are forward-looking statements within the meaning of the Securities Act of 1933, as amended. Those statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements reflect management’s current views, are based on certain assumptions and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to, the Company’s ability to obtain additional financing, if and as needed, and access funds from its existing financing arrangements that will allow it to continue its current and future operations and whether demand for its test products in domestic and international markets will generate sufficient revenues to achieve positive cash flow and profitability. The Company undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in the Company’s expectations with regard to these forward-looking statements or the occurrence of unanticipated events.
Sedia Biosciences Corporation
Ronald Mink, 503-459-4159