Newmark Diagnostics LLC — Department of Health and Human Services STTR Phase I: NIMH

Description

PROJECT SUMMARY ABSTRACT The development of a low costpoint of care diagnostic device or kit in arapid testorself testformat would be highly beneficial to the global effort to diagnosemanage and treat HIVWe are proposing to evaluate the scientific finding that HIV proteins are present in urine associated with extracellular vesiclesalso commonly referred to as exosomesThe development of one or more diagnostic tests designed to detect and measure extracellular vesicle associated HIV proteins in urine is the ultimate goalBecause viral proteins are detectedand not HIV specific antibodiesthis type of diagnostic assay will be useful for detecting infectionincluding during the acute phase prior to the development of antibodiesmonitoring disease status under antiretroviral therapy and discriminating between infection and vaccinationProducts 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 devicessimilar to home pregnancy testsPreliminary data are limited but they clearly demonstrate that HIV proteins can be readily detected in the urine of HIV patientsThe findings are novelpatent protected in all major potential markets and manufacturing countriesThe intellectual property is available to NewMark Diagnostics LLC through an exclusive option license agreementFor the proposed research we will critically evaluate the working hypothesis that viral load in HIVpatientsmeasured in plasmais positively correlated with our ability to detect extracellular vesicle associated HIV proteins in urineTo accomplish thiswe will first determine the plasma viral load using blood samples provided by HIVvolunteers using an FDA approved PCR based testA 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 HIVvolunteersWe will determine preliminaryassay cut off valuesas an estimate of the EIA sensitivity using multiple statistical analyses including Receiver Operator Characteristic CurvesThe 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 PROJECT NARRATIVE The development of a low costrapid test or self test for HIV that can be used in various medical settingsor even at homeis the ultimate goalWe are proposing to complete a critical research study to determine the potential value of the scientific finding that HIV proteins present in urineProposed is the first step towards the development of one or more diagnostic testssimilar to home pregnancy tests and designed for self testing or rapid testingto measure HIV proteins in urine would be highly beneficial to the global effort to diagnosemanage and treat HIV