SBIR-STTR Award

We propose to develop a highly sensitive, specific, reproducible and rapid point-of-care nucleic acid test based on IQuum's lab-in-a-tube (Liat(tm)) platform for the detection of and quantification of HIV-1 Group M virus in infected patients. The Liat HIV Assay will utilize the Liat Analyzer to enable minimally trained personnel the ability to perform the HIV-1 Quantitative test at a hospital, clinic, rural health center, physician's office or in the field. By enabling effective and sensitive HIV-1 quantitative testing, we expect that the Liat assay will: (i) allow clinicians to identify HIV-1 infected volunteers for clinical trials (both vaccine and treatment trials), (ii) allow clinicians monitoring clinical trials a rapid testing methodology for the determination of vaccine treatment benefit in infected patients, (iii) health personnel to detect and quantitate HIV-1 virus in acutely infected patients, (iv) allow point-of-care real time testing of infect patients on highly active antiretroviral therapy (HAART) allowing treating physicians the ability to make treatment decisions and (v) testing of pediatric patients where testing is complex due to maternal antibodies and sample volumes. The Liat HIV 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 prevention due to significant patient loss to follow-up and lack of penetration into resource-poor regions in the US and abroad. In Phase I of this project, we intend to prove the feasibility and initial verification of a rapid-self contained sample-to-result Liat HIV-1 Quantitative Assay. This will be done by the porting and optimize the existing commercialized HIV-1 assay chemistry to the Liat system. We further intend to characterize and verify that the Liat HIV Assay has the capability of quantifying representative samples from all subtypes within Group M. At the conclusion of this project, we will be prepared to carry the Liat HIV assay to the next level of validation and analytical characterization. The assay will be among the first point-of-care nucleic acid tests, and will provide significant benefit to public health. The Liat HIV Assay will utilize the Liat Analyzer to enable minimally trained personnel the ability to perform the HIV-1 Quantitative test at a hospital, clinic, rural health center, physician's office or in the field. By enabling effective and sensitive HIV-1 quantitative testing, we expect that the Liat assay will: (i) allow clinicians to identify HIV-1 infected volunteers for clinical trials (both vaccine and treatment trials), (ii) allow clinicians monitoring clinical trials a rapid testing methodology for the determination of vaccine treatment benefit in infected patients, (iii) health personnel to detect and quantitate HIV-1 virus in acutely infected patients, (iv) allow point-of-care real time testing of infect patients on highly active antiretroviral therapy (HAART) allowing treating physicians the ability to make treatment decisions and (v) testing of pediatric patients where testing is complex due to maternal antibodies and sample volumes. The Liat HIV 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 prevention due to significant patient loss to follow-up and lack of penetration into resource-poor regions in the US and abroad

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.

Public Health Relevance Statement:
Project Narrative 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.

Project Terms:
AIDS Virus; Abscission; Achievement; Achievement Attainment; Acquired Immune Deficiency Syndrome Virus; Acquired Immunodeficiency Syndrome Virus; Active Follow-up; Algorithms; Assay; Bioassay; Biologic Assays; Biological Assay; Blood Plasma; Capital; Cervical; Clinic; Clinical Research; Clinical Study; Clinics and Hospitals; Clinics or Hospitals; Collaborations; Computer Programs; Computer software; Detection; Development; Devices; Diagnostic; Disease; Disorder; Dose; Drugs; Ensure; Europe; Excision; Extirpation; FDA; Figs; Figs - dietary; Food and Drug Administration; Food and Drug Administration (U.S.); Funding; Gene Products, RNA; Goals; HIV; HIV-1; HIV-I; HIV1; HOSP; HTLV-III; Health; Hospital Information Systems; Hospitals; Hour; Human Immunodeficiency Viruses; Human Resources; Human T-Cell Leukemia Virus Type III; Human T-Cell Lymphotropic Virus Type III; Human T-Lymphotropic Virus Type III; Human immunodeficiency virus 1; Immunodeficiency Virus Type 1, Human; Intellectual Property; Intervention; Intervention Strategies; LAV-HTLV-III; Laboratories; Letters; Licensing; Lymphadenopathy-Associated Virus; Manpower; Marketing; Medication; Molecular; Monitor; NAT; NIH; National Institutes of Health; National Institutes of Health (U.S.); Nucleic Acid Amplification Tests; Nucleic Acid Testing; Nucleic Acids; Operation; Operative Procedures; Operative Surgical Procedures; Outcome; PCR; Patients; Persons; Pharmaceutic Preparations; Pharmaceutical Preparations; Phase; Physicians' Offices; Plasma; Polymerase Chain Reaction; Preparation; Process; Production; Protocols, Treatment; Public Health; QOL; Quality of life; RGM; RNA; RNA, Non-Polyadenylated; Reagent; Regimen; Removal; Reporting; Research; Research Resources; Resources; Reticuloendothelial System, Serum, Plasma; Ribonucleic Acid; Rural Health Centers; Sampling; Scanning; Serum, Plasma; Social Welfare; Software; Solutions; Surgical; Surgical Interventions; Surgical Procedure; Surgical Removal; System; System, LOINC Axis 4; Technology; Testing; Therapeutic; Time; Training; Treatment Failure; Treatment Protocols; Treatment Regimen; Treatment Schedule; Treatment outcome; Tube; USFDA; United States Food and Drug Administration; United States National Institutes of Health; Validation; Viral Burden; Viral Load; Viral Load result; Virus-HIV; Visit; WHBLOOD; Whole Blood; antiretroviral therapy; base; commercialization; computer program/software; cost; disease prevention; disease/disorder; disorder prevention; drug/agent; effective intervention; follow-up; human T cell leukemia virus III; human T lymphotropic virus III; improved; inhibitor; inhibitor/antagonist; interventional strategy; manufacturing process; novel; personnel; point of care; pre-clinical; preclinical; preclinical study; product development; public health medicine (field); public health relevance; resection; rural health clinic; surgery; touch panel; touch screen; touch screen panel; touchscreen; touchscreen panel; welfare