Clinical Study for Liat HIV Quant Assay for Viral Load Testing in One Hour in Nea

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DESCRIPTION (provided by applicant): We propose to complete the late stage development and clinical validation of the Liat(tm) HIV-1 Assay for the quantitation of Human Immunodeficiency Virus-1 (HIV-1) RNA in less than 1 hour in near patient settings. Based on IQuum's lab-in-a-tube platform, the Liat HIV-1 Assay will utilize the Liat Analyzer to enable minimally trained personnel to perform the HIV-1 test at a hospital, clinic or physician's office in less than 1 hour. The assay overcomes the limitations of current HIV-1 tests, whose long turnaround time and technical complexity requires testing to be performed in centralized laboratories and results in delayed or missed opportunities for timely therapeutic intervention. By enabling effective and sensitive single-visit HIV-1 quantitative testing at the near patient setting, we expect that the Liat HIV-1 assay will allow clinicians to timely assessing patient prognosis or the monitoring of antiretroviral therapy (ART). It may also aid in the diagnosis of HIV-1 infection, including acute infection. This real-time decision making can more effectively prevent clinical progression, providing increased quality of care for HIV-infected individuals. We propose to complete the development and clinical validation of the Liat HIV-1 Assay under this BRDG-SPAN program. We will perform clinical sample characterization and conduct multi-site clinical study on the Liat HIV-1 Assay in collaboration with leading clinical AIDS researchers. At the end of this program, we expect to be prepared to submit for Food and Drug Administration (FDA) Pre-Market Approval for the intended use of viral load determination for therapeutic monitoring and prognosis. PUBLIC HEALTH RELEVANCE: By enabling effective and sensitive single visit HIV-1 quantitative testing, the Liat(tm) HIV-1 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 Assay overcomes the limitations of current HIV-1 tests, including long turnaround time and technical complexity requiring testing to be performed in centralized laboratories and results in missed or delayed opportunities for disease intervention. The assay will also be among the first near-patient nucleic acid viral load tests, and will provide significant benefit to patient health and welfare.