SIMULTANEOUS SCREENING FOR A/H3N2, A/H1N1, A/H5N1 AND B INFLUENZA VIRUSES

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$2,988,813.00
Award Year:
2011
Program:
SBIR
Phase:
Phase II
Contract:
2R44AI077112-03A1
Award Id:
n/a
Agency Tracking Number:
R44AI077112
Solicitation Year:
2011
Solicitation Topic Code:
NIAID
Solicitation Number:
PA10-123
Small Business Information
2100 Central Ave, Suite 106, BOULDER, CO, -
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
Y
Duns:
132347787
Principal Investigator:
ERICA DAWSON
(303) 402-9100
dawson@indevr.com
Business Contact:
SHANNON RODRIGUEX
(303) 402-9100
shannon@indevr.com
Research Institution:
Stub




Abstract
DESCRIPTION (provided by applicant): The objective for this Phase II application is to develop a cartridge-based automated molecular diagnostic platform to rapidly and cost-effectively detect and identify influenza viruses. The system will automate all keyfunctions for sample processing including extraction, amplification, colorimetric detection on a low- density microarray, and image/result interpretation. The idea is to make the system easy to use so that personnel with no PCR or microarray experience could obtain an unequivocal answer with minimal hands- on time. The motivation for the proposed work is the tremendous impact influenza viruses have on human and animal health and the need for rapid, inexpensive tools for strain surveillance. The intent is to significantly enhance influenza virus surveillance by providing a new tool to affordably and rapidly identify influenza viruses without expertise in PCR methods and without exclusive reliance on existing, sometimes poor performing, rapid immunoassays. The marketing plan involves providing the instrument to customers at no capital cost (i.e., the reagent rental concept). Therefore, the instrument will be designed with simplicity and low cost in mind. Our market entry point will be influenza surveillancesites, such as state public health labs, where the FluChip assay could be used to track viruses without the need to diagnose patients. Long term, we will use data acquired in these early studies to formulate an FDA submission for 510(k) clearance for use as an in vitro diagnostic. PUBLIC HEALTH RELEVANCE: The objective of the proposed work is to build on the success achieved in Phase I for rapidly identifying influenza viruses by developing a cartridge based system for automated and self-contained sample processing, including extraction, amplification, and colorimetric detection on a low-density microarray.

* information listed above is at the time of submission.

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