Sept. 16, 2016—Sedia Biosciences will receive an award of a $1.8 million phase two National Institutes of Health Small Business Innovation Research grant to accelerate development of Sedia’s Asanté HIV-1 Rapid Recency™ Assay. The new test, using a portable handheld reader, can estimate how recently an HIV infection occurred from from a fingerstick drop of blood, generating results within 20 minutes.
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. The assay also will identify patients suitable for therapeutic regimens targeting “functional cure” approaches that are funded by the NIH and other funders and undergoing evaluation in laboratories around the world. 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 would enable the simultaneous diagnosis and recency characterization in low-resource environments and at the point of care.
“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,” Sedia president and chief science officer Ronald W. Mink, PhD, said in a statement. “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.” Dr. Mink also is the principal investigator on the grant from the NIH’s National Institute of Allery and Infectious Diseases.