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Novel Single Well Avidity EIA to Determine Recency of HIV-1 Infections

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43AI097001-01A1
Agency Tracking Number: R43AI097001
Amount: $194,123.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA11-096
Timeline
Solicitation Year: 2012
Award Year: 2012
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
4900 NE 122ND AVE
PORTLAND, OR 97230-1049
United States
DUNS: 16504083
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 RONALD MINK
 (503) 459-4159
 rmink@sediabio.com
Business Contact
 RONALD MINK
Phone: (503) 459-4159
Email: rmink@sediabio.com
Research Institution
 Stub
Abstract

DESCRIPTION (provided by applicant): The objective of this project is to develop a commercially viable single well HIV-1 Limiting Antigen Avidity EIA and establish its suitability fo determination of recency of HIV-1 infection. An accurate tool for distinguishing recent from long-term HIV infections is important in the determination of HIV incidence rates in populations, and may also be useful for providing tailored therapeutic, counseling and contact follow-up of individuals. The assay will be developed based on technology developed and licensed by the U.S. Centers for Disease Control (CDC). Upon completion of technology transfer from the CDC, Sedia will incorporate proprietary technology to develop a robust, stable, user-friendly assay. The project is of significant relevance to the CDC, as the CDC currently manages a national HIV/AIDS surveillance system that is the nation's source for timely information used to track the epidemic in the U.S. The CDC uses HIV recency data from that system to make estimatesof HIV incidence and track the epidemic, and is seeking to obtain more accurate data through the use of better assays, such as the HIV-1 Limiting Antigen Avidity EIA. The assay may be used as well by researchers, epidemiologists, other governmental and private public health organizations and vaccine trial program managers to understand and target the epidemic, as well as assess effectiveness of intervention programs. Sedia intends to collaborate with the CDC on this project by developing the assay according to CDC needs and specifications, and evaluate the resulting assay in cooperation with the CDC using archived cross-sectional serum specimens of known recency to determine the accuracy of the test, before expanding testing to multiple outside investors inPhase II of the project. PUBLIC HEALTH RELEVANCE: This project is for the development of a commercially viable single well HIV-1 Limiting Antigen Avidity EIA and to establish its suitability for determination o recency of HIV-1 infection. The CDCuses HIV recency data to make estimates of HIV incidence and track the epidemic, and is seeking to obtain more accurate data through the use of better assays, such as the HIV-1 Limiting Antigen Avidity EIA. The assay will be used to generate improved estimates of HIV incidence not only in the U.S., but in populations around the world.

* Information listed above is at the time of submission. *

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