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Applicability of smartDNA Rapid Detection of Priority Agents in Food

Award Information
Agency: Department of Health and Human Services
Branch: Food and Drug Administration
Contract: 1R43FD003463-01A1
Agency Tracking Number: FD003463
Amount: $98,947.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: N/A
Solicitation Number: N/A
Timeline
Solicitation Year: N/A
Award Year: 2009
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
750 ALFRED NOBEL DRIVE, SUITE 109
HERCULES, CA 94547
United States
DUNS: 117194642
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 RICHARD BLIDNER
 () -
Business Contact
 HEATHER KOSHINSKY
Phone: () -
Email: ceo@investigen.com
Research Institution
N/A
Abstract

DESCRIPTION (provided by applicant): While the United States food supply is among the safest in the world it is vulnerable to terrorist attacks as well as occasional accidental contamination from inadequate sanitation at packing and manufacturing facilitie
s; e.g. the recent E. coli contamination of pre-washed bagged spinach. The research to be completed in this project will determine the feasibility of using Investigen's smartDNA nucleic acid detection method to detect priority agents that have been intent
ionally added to a food. This is NOT intended as a food safety assay. It is intended as an assay for food security. Thus, the target organisms are biothreat agents as opposed to typical foodborne pathogens. The smartDNA detection system is an easy, rapid,
isothermal (including room temperature), sequence-specific, colorimetric system for the detection of nucleic acids. Investigen currently has a smartDNA-based assay for the detection of Mycobacterium tuberculosis from sputum. On a separate project Investige
n is developing prototypes of smartDNA assays and instrumentation for use by first responders for the detection of multiple bio-terrorism agents (Bacillus anthracis, Francisella tularensis and Yersinia pestis). This application builds on the results of the
se two initiatives and will determine the feasibility of using Investigen's smartDNA assay for the detection of nucleic acids from F. tularensis in food matrices. Detection of bacteria in foods is often confounded by the food matrix. Food matrices are comp
lex, heterogeneous and not as well studied as clinical matrices. Detection systems that work in other matrices often are not able to detect the same bacteria when present in a food matrix. Thus Investigen will test the impact of food matrices on the smartD
NA-based detection of F. tularensis. All aspects of the system will be tested, including the effect of food matrices (including processed samples from food matrices) on: (1) disruption of F. tularensis cells, (2) smartDNA-based target capture and release,
and (3) smartDNA-based homogeneous detection of F. tularensis following sample processing. The results of these tests will be compared to the results of Investigen's standard smartDNA- based tests for the detection of F. tularensis. Based on the results, m
inimal inhibitory concentration each food matrix and the limit of detection of F. tularensis (isolated NA or whole cells - depending on the experiment) will be determined. Additionally, with a limited number of samples the assay's sensitivity and specifici
ty will be evaluated. If the food matrices have a large negative effect on the smartDNA detection assay, then the buffers and reagents will be adjusted to attempt to mitigate this effect. The detection of Y. pestis and B. anthracis in food matrices will be
a Phase II objective. PUBLIC HEALTH RELEVANCE: While the U.S. food supply is among the safest in the world, it is vulnerable to terrorist attacks and accidental contamination from inadequate sanitation at packing and manufacturing facilities. The research
to be completed in this project will determine the feasibility of using Investigen's smartDNA nucleic acid detection technology to detect priority agents in a food matrix; a system that can be used in the field, in labs, at the point of harvest or manufac
ture and at importing locations such as U.S. borders and maritime ports. The rapid field deployable detection could aid in the identification and containment of contaminated food and reduce the impact on public health.

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

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