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Automated Molecular Diagnostics for Rapid Detection of Dengue Viremia Using Whole

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R44AI085892-02
Agency Tracking Number: R44AI085892
Amount: $1,707,133.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA09-080
Timeline
Solicitation Year: 2011
Award Year: 2011
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
700 Nickerson Rd
MARLBOROUGH, MA -
United States
DUNS: 125606017
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 SHUQI CHEN
 (508) 970-0099
 SHUQI@IQUUM.COM
Business Contact
 DANIEL SUTHERBY
Phone: (508) 970-0099
Email: dsutherby@iquum.com
Research Institution
 Stub
Abstract

DESCRIPTION (provided by applicant): We propose to develop a highly sensitive and rapid point-of-care nucleic acid test based on IQuum's lab-in-a-tube (Liat ) platform for the diagnosis of patients with dengue fever or dengue hemorrhagic fever from whole blood samples. The Liat Dengue Assay will utilize the Liat Analyzer to enable the minimally trained personnel to perform the dengue infection test at a hospital, clinic or physician's office in less than 1 hour. By enabling effective and sensitive dengue infection testing, we expect that the Liat assay will allow clinicians to quickly diagnose patients with dengue fever or dengue hemorrhagic fever and initiate appropriate treatments. The Liat Dengue Assay overcomes the limitations of current dengue infectiontests, whose long turnaround time and technical complexity requires testing to be performed in centralized laboratories, resulting in missed opportunities for disease treatment or the continued use of ineffective treatment regimens. The assay will also beamong the first near patient nucleic acid tests, and will provide significant benefit to patient health and welfare, as well as enhance the preparedness for this emerging disease. In Phase I, we propose to transfer the Liat Dengue Assay to manufacturingand perform analytical sensitivity and specificity studies. In Phase II, we propose to complete the analytical studies, develop and validate manufacturing processes for the Liat Dengue Assay, and conduct clinical sample study to validate the assay. At theconclusion of the pre-clinical and analytical studies, we will submit a pre-investigational device exemption (pre-IDE) to the FDA in preparation for expanded clinical study of the Liat Dengue Assay for 510(K) market clearance. PUBLIC HEALTH RELEVANCE: By enabling effective and sensitive dengue infection testing, the Liat Dengue Assay will allow clinicians to quickly diagnose patients with dengue fever or dengue hemorrhagic fever. The Liat Dengue Assay overcomes the limitations of current dengue infection tests, whose long turnaround time and technical complexity requires testing to be performed in centralized laboratories, resulting in missed opportunities for disease treatment or the continued use of ineffective treatment regimens. The assay will also be among the first near patient nucleic acid tests, and will provide significant benefit to patient health and welfare, as well as to enhance the preparedness for this emerging disease.

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

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