NIH Awards Phase II SBIR Grant Funding to Sedia to accelerate development of HIV-1 Rapid Recency™ Test
Portland, Oregon – Sedia Biosciences Corporation has received notification from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (NIH) of the award of a $1.8 Million Phase II Small Business Innovation Research (SBIR) Grant to accelerate development of Sedia’s Asanté™ HIV-1 Rapid Recency™ Assay. The new assay or test, utilizing a portable handheld reader, can estimate how recently an HIV infection occurred, from results obtained in 20 minutes from a finger stick drop of blood. Upon regulatory approval, the test will identify individuals infected with HIV and determine how recently the individual was infected. As a diagnostic tool, the test would provide additional information about infected individuals above and beyond the mere presence of infection. The test will enable enhanced case management, including selective, targeted, follow-up and contact tracing of recently infected individuals, known to be at highest risk of transmission to others due to the initial viral load spike typical of early infections. Further, of potentially greater value to society, is the ability of the test to identify suitable candidate individuals for therapeutic regimens targeting “functional cure” approaches that are currently being funded by NIH and other funders and undergoing evaluation in various laboratories around the world. Functional cures are therapy regimens where treatment does not effect a true or “sterilizing cure”, or total elimination of the virus. Instead, persons with early infections are treated with a “kick and kill” approach to the HIV virus in the body, using therapies to activate dormant HIV (“kick”) in the patient’s latent viral reservoirs. When performed in conjunction with antiviral therapy (“kill”) the viral load may be reduced to levels so low that therapy can be suspended without previously observed resurgence of virus in the body. Identification of recent or early infections before latent virus levels become too high or genetically diverse and therefore resistant to therapeutic agents is believed to be important for the success of such regimens.
Tests for recency of HIV infection, including the commercialized Sedia™ HIV-1 LAg-Avidity EIA, are already being used to identify candidate individuals for early assessment studies of functional cures. The Asanté™ HIV-1 Rapid Recency™ Assay enables the simultaneous diagnosis and recency characterization in low resource environments and at patient point of care with results provided in just minutes.
Prior to regulatory approval, the test will be available on a Research Use Only basis and can also be used by epidemiologists to identify HIV new infections, enabling estimates of HIV-1 incidence rates without relying on complex laboratory based assays or costly longitudinal cohort studies.
Dr. Ronald W. Mink, President and Chief Science Officer of Sedia Biosciences and the Principal Investigator on the grant, stated “We are already seeing significant interest in the Asanté™ Rapid HIV-1 Recency Assay from Public Health groups for near-term applications to quickly obtain data on HIV epidemic progression, and have further received requests from researchers to use the assay in trials for individual case management. As the development of new therapeutic regimens for functional cure approaches expands, there is tremendous potential for this test to play a significant role in controlling the global AIDS epidemic.”
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.
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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™ LAg-Avidity EIA and BED HIV-1 Incidence 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.
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