Development of a rapid screening point-of-care test for HIV, HCV and HBV

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R44AI096758-01A1
Agency Tracking Number: R44AI096758
Amount: $145,915.00
Phase: Phase I
Program: SBIR
Awards Year: 2012
Solitcitation Year: 2012
Solitcitation Topic Code: NIAID
Solitcitation Number: PA11-096
Small Business Information
ORASURE TECHNOLOGIES, INC.
220 E 1ST ST, BETHLEHEM, PA, 18015-1360
Duns: 114152184
Hubzone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 STEPHEN LEE
 (610) 882-1820
 slee@orasure.com
Business Contact
 MARYJEAN SHINE
Phone: (610) 882-1820
Email: mshine@orasure.com
Research Institution
 Stub
Abstract
DESCRIPTION (provided by applicant): The objective of this research application is the development of a simple, highly portable test system for rapid screening for human immunodeficiency virus (HIV) and hepatitis at the point of care (POC). This test system will be capable of identifying patients infected by HIV, hepatitis C virus (HCV) and hepatitis B virus (HBV) in a small drop of blood obtained by finger stick. This will allow the use of this test syste in settings such as physician offices, public health testing clinics, community outreach centers and mobile testing facilities. It is the intention to obtain regulatory approvals in the US, such tat this system can be used outside of traditional laboratory settings by individuals with minimal training. This will enable maximum access to populations at greatest risk for HIV and hepatitis. It is expected that by enabling increased testing of high risk populations, a higher proportion of infected individuals will be diagnosed and gain earlier access to appropriate medical treatment. The test system will consist of test cartridges specific for each disease state and a simple-to-use instrument providing objective results to the user. Use of manual, rapid tests has previously been shown to be effective in increasing diagnosis of HIV. Currently, approximately 25% of HIV infection and more than half of the cases of HCV and HBV infection are undiagnosed. This reservoir of undiagnosed infection represents a growing burden of mortality and morbidity and also contributes to greater transmission rates within the population. Improved therapeutic outcomes in infected individuals who are treated earlier in the course of disease are now well documented. Improved the rapid tests for treatment of HCV were recently approved inthe US and reduction of future morbidity and mortality will be highly dependent on expanded testing and diagnoses. Additionally, early treatment of HIV infected individuals has been shown to greatly reduce the risk of disease transmission. Increased testing and treatment of individuals infected with these blood borne viruses will significantly improve health outcomes in infected individuals and reduce transmission through reduction of community viral burden. PUBLIC HEALTH RELEVANCE: The purpose ofthis project is to develop a new and proprietary system that can detect the presence of infection by HIV, hepatitis B or hepatitis C from a small drop of finger-stick blood. This will expand testing opportunities, increase disease diagnoses and enable moreindividuals to become more aware of their status and thus receive earlier intervention in the course of disease. This will result in improved health care outcomes; reduced disease transmission, as well as reducing overall medical costs.

* information listed above is at the time of submission.

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