SBIR-STTR Award

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.

Public Health Relevance Statement:
Project Narrative By enabling effective and sensitive single visit HIV-1 quantitative testing, the Liat" 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 requires 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.

Project Terms:
Abscission; Acquired Immune Deficiency; Acquired Immune Deficiency Syndrome; Acquired Immune Deficiency Syndrome Virus; Acquired Immuno-Deficiency Syndrome; Acquired Immunodeficiency Syndrome; Acquired Immunodeficiency Syndrome Virus; Acute; AIDS; AIDS clinical trial group; AIDS Virus; antiretroviral therapy; Assay; base; Bioassay; Biologic Assays; Biological Assay; Blood Plasma; Capital; cGMP; Clinic; Clinical; Clinical Data; Clinical Evaluation; Clinical Research; Clinical Study; clinical test; Clinical Testing; Clinics and Hospitals; Clinics or Hospitals; Collaborations; Comb animal structure; Combs; Community Health; cost; Cyclic GMP; Decision Making; Detection; Development; Diagnosis; Diagnostic; Disease; disease/disorder; Disorder; Doctor of Philosophy; Dose; effective intervention; Excision; Extirpation; FDA; Figs; Figs - dietary; Food and Drug Administration; Food and Drug Administration (U.S.); Forecast of outcome; Funding; Gene Products, RNA; Grant; guanosine 3'5' monophosphate; Guanosine Cyclic 3',5'-Monophosphate; Guanosine Cyclic Monophosphate; Guanosine, cyclic 3',5'-(hydrogen phosphate); Health; HIV; HIV-1; HIV-I; HIV1; HOSP; Hospitals; Hour; HTLV-III; Human immunodeficiency virus 1; Human Immunodeficiency Viruses; Human Resources; human T cell leukemia virus III; human T lymphotropic virus III; Human T-Cell Leukemia Virus Type III; Human T-Cell Lymphotropic Virus Type III; Human T-Lymphotropic Virus Type III; Immunodeficiency Virus Type 1, Human; Immunologic Deficiency Syndrome, Acquired; improved; Individual; Infection; inhibitor; inhibitor/antagonist; Intervention; Intervention Strategies; intervention therapy; interventional strategy; Investigators; Label; Laboratories; LAV-HTLV-III; Life; Lymphadenopathy-Associated Virus; Manpower; Manuals; Marketing; Molecular; Monitor; multi center clinical study; multi center clinical trial; multi site clinical study; multi site clinical trial; Multi-center clinical study; Multi-center clinical trial; Multi-Institutional Clinical Trial; Multi-site clinical study; Multi-site clinical trial; NAT; National Institutes of Health; National Institutes of Health (U.S.); NIH; novel; Nucleic Acid Amplification Tests; Nucleic Acid Testing; Nucleic Acids; operation; outcome forecast; Patients; PCR; personnel; Persons; Ph.D.; Phase; PhD; Physicians' Offices; Plasma; Polymerase Chain Reaction; preclinical study; prevent; preventing; Principal Investigator; Process; Prognosis; programs; Programs (PT); Programs [Publication Type]; public health relevance; QOC; QOL; Qualifying; Quality of Care; Quality of life; Reagent; Removal; Reporting; Research; research clinical testing; Research Personnel; Researchers; resection; Reticuloendothelial System, Serum, Plasma; Ribonucleic Acid; RNA; RNA, Non-Polyadenylated; Rural Community; Sampling; SBIR; SBIRS (R43/44); Scanning; Serum, Plasma; Site; Small Business Innovation Research; Small Business Innovation Research Grant; Social Welfare; Specificity; Staging; Surgical Removal; System; System, LOINC Axis 4; Technology; Testing; Therapeutic; therapeutic efficacy; Therapeutic Intervention; therapeutically effective; Time; touch panel; touch screen; touch screen panel; touchscreen; touchscreen panel; Training; Treatment Efficacy; Treatment Failure; Tube; United States Food and Drug Administration; United States National Institutes of Health; USFDA; Validation; Viral Burden; Viral Load; Viral Load result; Virus-HIV; Visit; Washington; welfare; WHBLOOD; Whole Blood