SBIR-STTR Award

The objective of this project is to develop a commercially viable single well HIV-1 Limiting Antigen Avidity EIA and establish its suitability fo determination of recency of HIV-1 infection. An accurate tool for distinguishing recent from long-term HIV infections is important in the determination of HIV incidence rates in populations, and may also be useful for providing tailored therapeutic, counseling and contact follow-up of individuals. The assay will be developed based on technology developed and licensed by the U.S. Centers for Disease Control (CDC). Upon completion of technology transfer from the CDC, Sedia will incorporate proprietary technology to develop a robust, stable, user-friendly assay. The project is of significant relevance to the CDC, as the CDC currently manages a national HIV/AIDS surveillance system that is the nation's source for timely information used to track the epidemic in the U.S. The CDC uses HIV recency data from that system to make estimates of HIV incidence and track the epidemic, and is seeking to obtain more accurate data through the use of better assays, such as the HIV-1 Limiting Antigen Avidity EIA. The assay may be used as well by researchers, epidemiologists, other governmental and private public health organizations and vaccine trial program managers to understand and target the epidemic, as well as assess effectiveness of intervention programs. Sedia intends to collaborate with the CDC on this project by developing the assay according to CDC needs and specifications, and evaluate the resulting assay in cooperation with the CDC using archived cross-sectional serum specimens of known recency to determine the accuracy of the test, before expanding testing to multiple outside investors in Phase II of the project.

Public Health Relevance:
This project is for the development of a commercially viable single well HIV-1 Limiting Antigen Avidity EIA and to establish its suitability for determination o recency of HIV-1 infection. The CDC uses HIV recency data to make estimates of HIV incidence and track the epidemic, and is seeking to obtain more accurate data through the use of better assays, such as the HIV-1 Limiting Antigen Avidity EIA. The assay will be used to generate improved estimates of HIV incidence not only in the U.S., but in populations around the world.

Public Health Relevance Statement:
This project is for the development of a commercially viable single well HIV-1 Limiting Antigen Avidity EIA and to establish its suitability for determination o recency of HIV-1 infection. The CDC uses HIV recency data to make estimates of HIV incidence and track the epidemic, and is seeking to obtain more accurate data through the use of better assays, such as the HIV-1 Limiting Antigen Avidity EIA. The assay will be used to generate improved estimates of HIV incidence not only in the U.S., but in populations around the world.

NIH Spending Category:
HIV/AIDS

Project Terms:
Acquired Immunodeficiency Syndrome; Agreement; AIDS/HIV problem; Algorithms; Antigens; Applications Grants; Archives; Avidity; base; Biological; Biological Assay; Centers for Disease Control and Prevention (U.S.); Characteristics; Consultations; Contact Tracing; Counseling; Data; design; Development; Diagnostic; Effectiveness; Effectiveness of Interventions; Ensure; Epidemic; Epidemiologist; Evaluation; follow-up; Head; health organization; Health Personnel; Health Resources; HIV; HIV Infections; HIV-1; Housing; improved; Incidence; Individual; Infection; Information Systems; International; intervention program; Laboratories; Licensing; meetings; Methods; Modification; novel; Performance; Persons; Phase; Population; population based; Populations at Risk; Production; programs; public health medicine (field); Reagent; Regimen; Reproducibility; Research; Research Personnel; scale up; Serologic tests; Serum; Small Business Innovation Research Grant; Source; Specimen; Staging; Surveillance Program; System; Technology; Technology Transfer; Testing; Therapeutic; tool; user-friendly; Vaccines; Validation; Viral Load result

The objectives of this project are to develop a commercial single well HIV-1 Limiting Antigen Avidity EIA, developed in Phase I as a research tool, and establish its suitability for identifying recent HIV-1 infections on both a population an on an individual clinical basis as an aid to early intervention in acute infections. Such methods are needed for accurate measures of the incidence of new HIV infections to enable monitoring of the epidemic in populations, optimal targeting of public health resources and assessment of intervention effectiveness. In addition, identification of persons recently infected is important a these persons are typically hyper-infectious and at greater risk of transmitting the disease to partners. The scientific literature estimates that nearly half of all infections are transmitted frm partners who themselves are recent infections. Such high risk individuals should be aggressively identified treated, counseled and contact-traced to immediately reduce the risk of further transmission. In Phase I, the assay was developed for Research Use Only for liquid plasma and serum specimens and is being evaluated by the our collaborator, the CDC Global AIDS Program Laboratory Branch and other investigators around the world for its ability to measure HIV incidence in populations. In Phase II, the assay validation will be expanded and completed for conformation to consensus standards, including expanded testing by CDC, Consortium for Evaluation of Performance of HIV Incidence Assays (CEPHIA) and others seeking new and improved incidence assays. The assay will be further adapted to expand use to dried blood spot specimens (DBS) using proprietary formulations and approaches similar to those used for our current DBS products and evaluated along a similar path. DBS specimens are widely used in many developing countries preferentially, and sometimes exclusively, over liquid blood specimens and will expand access to this assay worldwide. In addition, an individual (diagnostic) use application will be developed, evaluated and validated. Application to individual use and management of care requires an FDA approved product in the U.S. In addition to a series of non-clinical laboratory studies to evaluate such parameters as the assay performance, accuracy, robustness and reproducibility, and to accurately assess recency window periods, extensive testing will be done with panels of well characterized specimens of established recency and compared to other incidence assays by CDC, CEPHIA and in-house and commercial panels. This data will be used to extend validation of population incidence application, support third party clinical trials of prospectively collected clinical specimens fromhigh risk longitudinal cohorts and culminate in an FDA application for approval for individual clinical use. The project is of additional significance to the U.S. Public Health, as the CDC currently manages a national HIV/AIDS surveillance system that is the nation's source for timely information used to track the epidemic in the U.S. The CDC uses HIV recency data from that system to make estimates of HIV incidence and track the epidemic in the U.S., and is seeking to obtain more accurate data through the use of potentially improved assays.

Thesaurus Terms:
Acquired Immunodeficiency Syndrome;Acute;Aids/Hiv Problem;Antibody Avidity;Antigens;Applications Grants;Avidity;Base;Biological Assay;Blood;Blood Specimen;Caring;Centers For Disease Control And Prevention (U.S.);Characteristics;Clinical;Clinical Application;Clinical Care;Clinical Diagnosis;Clinical Management;Clinical Trials;Cohort;Cold Chains;Commercialization;Complex;Consensus;Contact Tracing;Counseling;Critical Pathways;Data;Developing Countries;Diagnosis;Diagnostic;Disease;Drug Formulations;Early Intervention;Effectiveness Of Interventions;Epidemic;Epidemiologist;Epidemiology;Evaluation;Evaluation Research;Fda Approved;Field Study;Follow-Up;Funding;Health Resources;High Risk;Hiv;Hiv Antibodies;Hiv Infections;Hiv-1;Housing;Human Immunodeficiency Virus Test;Improved;Incidence;Individual;Infection;Information Systems;Intervention;Laboratories;Laboratory Study;Licensing;Liquid Substance;Literature;Marketing;Measurement;Measures;Meetings;Methods;Molecular Conformation;Monitor;Novel;Performance;Persons;Phase;Plasma;Population;Pre-Clinical;Prevalence;Prevention;Process;Product Approvals;Production;Programs;Protocols Documentation;Public Health Medicine (Field);Public Health Relevance;Reproducibility;Research;Research And Development;Research Personnel;Resources;Response;Risk;Scale Up;Series;Serum;Sexual Partners;Small Business Innovation Research Grant;Source;Specimen;Spottings;Stimulus;Success;Surveillance Program;System;Technology;Testing;Tool;Transmission Process;Validation;Work;