Project would expand application of Sedia’s HIV-1 LAg-Avidity EIA from incidence measurement in populations to individual diagnostic use determining recency of HIV-1 infection
February 12, 2014 07:30 AM Eastern Standard Time
PORTLAND, Ore.–(BUSINESS WIRE)–Sedia Biosciences Corporation of Portland, Oregon announced today that it has received a Notice of Award granting Phase II funding of its previous Small Business Innovation Research (SBIR) grant from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health. The Phase II funding is to continue development and commercialization for diagnostic use of Sedia’s HIV-1 Limiting Antigen (“LAg”)-Avidity EIA, a novel single well enzyme assay based on U.S. Centers for Disease Control and Prevention (“CDC”) licensed technology. The assay measures HIV-1 antibody avidity or “binding ability,” a measure of antibody maturation and indirectly disease progression. Sedia is already selling the HIV-1 LAg-Avidity EIA for use in surveillance and population studies as a Research Use Only product as a tool to measure HIV incidence, monitor the spread of the HIV epidemic and identify hot spots of new infections. Current users are primarily the CDC, Ministries of Public Health, and other public health groups around the world. The Phase II funding will enable Sedia to develop an FDA-regulated version of the assay for diagnostic use to determine how recently the individual was infected.
“Sedia has been very pleased with the reception that the Sedia™ HIV-1 LAg-Avidity EIA has received in the public health community and we are excited about the possibility of providing this as an aid to characterizing individual infections to better combat the HIV epidemic”
It has been estimated that as many as 40-50% of all new HIV infections are the result of transmission from infected individuals who themselves were recently infected. Recently infected individuals also tend to have significantly higher viral loads than individuals with longer term infections, presenting a potentially higher risk of transmission to uninfected sexual partners or others that may be exposed to their blood, such as drug users who share needles with them. HIV scientists and epidemiologists have advocated earlier identification of recently infected individuals to “triage” them for more aggressive treatment, follow-up and contact tracing, to reduce these risks of transmission. Having a tool to enable identification of recently infected individuals can also provide an additional means to develop treatments tailored to the individual.
“Sedia has been very pleased with the reception that the Sedia™ HIV-1 LAg-Avidity EIA has received in the public health community and we are excited about the possibility of providing this as an aid to characterizing individual infections to better combat the HIV epidemic,” stated Dr. Ronald Mink, Sedia’s President and Chief Science Officer. “The ongoing support for this assay from CDC, NIH and a broad range of public health groups around the world, we believe, demonstrates the value of making this assay available to clinicians treating infected individuals enabling them to better understand the disease state in such individuals.”
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 R44AI097001. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Additional information about the Sedia™ HIV-1 LAg-Avidity EIA is also available at www.hivincidence.com.
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. 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