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Point-of-Care Diagnostic Test for Entamoeba histolytica Cysts

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AI094733-01A1
Agency Tracking Number: R41AI094733
Amount: $599,260.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIAID
Solicitation Number: PA10-124
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
2001 KRAFT DR
BLACKSBURG, VA -
United States
DUNS: 614218634
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 JOEL HERBEIN
 (540) 953-1664
 jherbein@techlab.com
Business Contact
 DAVID WALL
Phone: (540) 953-1664
Email: dwall@techlab.com
Research Institution
 UNIVERSITY OF VIRGINIA CHARLOTTESVILLE
 
UNIVERSITY OF VIRGINIA BOX 400195
CHARLOTTESVILLE, VA 22904-4195
United States

 () -
 Nonprofit College or University
Abstract

DESCRIPTION (provided by applicant): The NIAID Category B priority pathogen Entamoeba histolytica is a public health threat, especially as a cause of diarrhea in travelers to and immigrants from endemic areas, men who have sex with men, and children in thedeveloping world where it is in the top 5 causes of severe diarrhea. It is also a biodefense threat to water and food supplies due to its resistance to chlorination and low infectious dose. Here we propose to develop a point-of-care (POC) fecal antigen diagnostic test. Successful completion of the project will produce the first POC test that detects E. histolytica in both fresh and formalin-fixe specimens]. Investigators: Dr. Herbein at TechLab is an expert in developing enteric diagnostics; having directed the FDA- clearance of diagnostics for Giardia and Cryptosporidia and having served as the PI for multiple Phase I/II SBIR/STTR projects. Dr. Petri at the University of Virginia is an international leader in clinical and basic investigation of amebiasis,and in collaboration with TechLab has developed the only FDA 510(k)-cleared diagnostic test for E. histolytica. [Innovation: Innovative aspects include: (1) development and manufacture of a POC test for amebiasis that can be multiplexed with that of othercategory B enteric parasites; and (2) production of the first diagnostic test for E. histolytica detection in both fresh and formalin-fixed samples]. [Approach: The following two Specific Aims are proposed to accomplish our goal of a new diagnostic test for amebiasis: 1) Produce monoclonal and polyclonal antibodies against the highly abundant Jacob protein of the E. histolytica cyst. 2) Apply these antibodies to produce a POC test for E. histolytica]. Environment: The proposal builds on the longstanding partnership of Dr. Petri at the University of Virginia with Dr. Herbein of TechLab, Inc. for amebiasis diagnostic test development. These two institutions are importantly only two hours apart and that have worked together successfully for over a decade.PUBLIC HEALTH RELEVANCE: Entamoeba histolytica is a biodefense threat and an important cause of diarrhea in: (a) travelers to, and immigrants from, endemic areas; (b) in men who have sex with men; and (c) in children in the developing world. We propose to produce a point-of-care assay for amebiasis that is rapid and easy to use, and that specifically detects E. histolytica (and not the non-pathogen E. dispar) in both fresh and fixed stool specimens.]

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

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