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Development of Point-of-Care Liat Quantitative HIV Assay

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44AI075946-02
Agency Tracking Number: AI075946
Amount: $1,871,560.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: N/A
Solicitation Number: PHS2009-2
Timeline
Solicitation Year: 2009
Award Year: 2009
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
IQUUM, INC. 700 Nickerson Rd
MARLBOROUGH, MA 01752
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
 ROBERT CASPER
Phone: (508) 970-0099
Email: shuqi@iquum.com
Research Institution
N/A
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 quantification of Human Immunodeficiency Virus (HIV-1) from plasma samples. The Liat HIV Assay will utilize the Liat Analyzer to enable the minimally trained personnel to perform the HIV-1 test at a hospital, clinic or physician's office in less than 1 hour. By enabling effective and sensitive single visit HIV-1 quantitative testing, we expect that the Liat assay will allow clinicians to rapidly change a patient's antiretroviral therapy once a significant change in viral load has been identified. The Liat HIV-1 Assay overcomes the limitations of current HIV-1 tests, whose long turnaround time and technical complexity requires testing to be performed in centralized laboratories, resulting in missed opportunities for rapid therapy changes disease prevention due to turn around times and patient follow-up. In Phase II, we propose to expand the assay developed from Phase I by integrating all assay components, including the internal quantitative controls, into a single Liat tube for multiplex HIV-1 quantification. In addition, a semi-automated manufacturing solution for Liat HIV-1 Assay Tube production will be developed and validated. Finally, the Liat HIV-1 Quantitative Assay will be characterized and validated in analytical and pre-clinical studies. At the conclusion of this phase of the project, we will be prepared to initiate external clinical studies in support of a PMA submittal to the Food and Drug Administration (FDA). The assay will be among the first point-of-care nucleic acid tests, and will provide significant benefit to public health. PUBLIC HEALTH RELEVANCE: By enabling effective and sensitive single visit HIV-1 quantitative testing, the Liat HIV-1 Quantitative Assay will allow clinicians to quickly identify treatment failure and provide immediate and effective intervention, thereby significantly improving the quality of life for HIV-1 infected persons. The Liat HIV-1 Quantitative Assay overcomes the limitations of current HIV-1 tests, whose long turnaround time and technical complexity requires testing to be performed in centralized laboratories, resulting in missed opportunities for disease intervention due to maintaining patients for extended times on ineffective treatment regimens. The assay will also be among the first point-of-care nucleic acid tests, and will provide significant benefit to patient health and welfare.

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

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