SBIR-STTR Award

The development of a low cost, point of care diagnostic device or kit in a “rapid test” or “self test” format would be highly beneficial to the global effort to diagnose, manage and treat HIV. We are proposing to evaluate the scientific finding that HIV proteins are present in urine associated with extracellular vesicles, also commonly referred to as exosomes. The development of one or more diagnostic tests designed to detect and measure extracellular vesicle-associated HIV proteins in urine is the ultimate goal. Because viral proteins are detected, and not HIV-specific antibodies, this type of diagnostic assay will be useful for detecting infection, including during the acute phase prior to the development of antibodies, monitoring disease status under antiretroviral therapy and discriminating between infection and vaccination. Products can be developed and ultimately produced using technologies and materials that are standard to the industry and assay formats can be produced as standard EIA kits or as single patient lateral flow devices, similar to home pregnancy tests. Preliminary data are limited but they clearly demonstrate that HIV proteins can be readily detected in the urine of HIV patients. The findings are novel, patent protected in all major potential markets and manufacturing countries. The intellectual property is available to NewMark Diagnostics LLC through an exclusive option license agreement. For the proposed research we will critically evaluate the working hypothesis that viral load in HIV+ patients, measured in plasma, is positively correlated with our ability to detect extracellular vesicle-associated HIV proteins in urine. To accomplish this, we will first determine the plasma viral load using blood samples provided by HIV+ volunteers using an FDA-approved PCR-based test. A research level extracellular vesicle capture EIA will then be used to measure the concentration of multiple HIV proteins in urine samples obtained from the same HIV+ volunteers. We will determine preliminary “assay cut-off values” as an estimate of the EIA sensitivity using multiple statistical analyses including Receiver Operator Characteristic Curves. The evaluation of the basic scientific discovery in this manner is a crucial first step towards the potential future development of a new type of rapid diagnostic test for HIV that can be used globally and in numerous settings.

Public Health Relevance Statement:
PROJECT NARRATIVE The development of a low cost, rapid test or self-test for HIV that can be used in various medical settings, or even at home, is the ultimate goal. We are proposing to complete a critical research study to determine the potential value of the scientific finding that HIV proteins present in urine. Proposed is the first step towards the development of one or more diagnostic tests, similar to home pregnancy tests and designed for self-testing or rapid testing, to measure HIV proteins in urine would be highly beneficial to the global effort to diagnose, manage and treat HIV.

Project Terms:
Accident and Emergency department; Acute; Agreement; Antibodies; antiretroviral therapy; Area; base; Benchmarking; Biological Assay; Blood Banks; Blood specimen; Clinic; cost; Country; Data; design; Detection; Development; Development Plans; Devices; Diagnosis; Diagnostic; diagnostic assay; Diagnostic tests; Disease; Doctor of Philosophy; Environment; Enzyme Immunoassay; Evaluation; exosome; extracellular vesicles; FDA approved; Foundations; Future; Goals; Government; Health; HIV; HIV Infections; HIV serology; Home environment; Human immunodeficiency virus test; Individual; Industry; Infection; Infrastructure; Institution; Intellectual Property; Lateral; Legal patent; Licensing; Measures; Medical; Methods; Monitor; Morehouse School of Medicine; novel; off-patent; Patients; Performance; Phase; Physicians' Offices; Plasma; point-of-care diagnostics; Pregnancy Tests; Privatization; product development; programs; Proteins; Reader; Receiver Operating Characteristics; Research; research study; Resources; Sampling; Sensitivity and Specificity; Serologic tests; Small Business Technology Transfer Research; standard of care; Statistical Data Interpretation; Technology; Testing; Time; urinary; Urine; Vaccination; Viral load measurement; Viral Load result; Viral Proteins