Novel Microdevices, LLC — Department of Health and Human Services SBIR Phase I: NIAID

Description

PROJECT ABSTRACT The overall goal of this Phase I SBIR proposal to prove the feasibility of developing a rapidandltminuteCLIA waivedfully automatedmolecular diagnostic technology for the multiplexed detection of two sexually transmitted infectionsSTIsChlamydia trachomatisCTandNeisseria gonorrhoeaeNGinfections are the number one and two most commonly reported bacterial STIswith an estimatedmillion andmillion new cases annually of CT and NGrespectively worldwideThese infections are curable with antibioticshowever no rapidaccurate diagnostic test is available to inform clinical treatment decisions during the patient visitUntreated infections lead to serious sequelae including pelvic inflammatory diseasePIDand its associated complicationssuch as ectopic pregnancyinfertilityand chronic pelvic painFurthermoreloss to follow up is a significant problem with STI patientsThereforetimely diagnosis using accurate diagnostics and early treatment is imperativeRapidimmunoassay based point of carePOCtests for CT NG fail to diagnose more thanof Chlamydia positive casesNucleic Acid Amplification TestsNAATsare the current gold standard for diagnosing CT NG due to their high sensitivity and specificityHowever the only FDA approved POC NAAT for CT NG is expensive and takes more thanminutes for diagnosisAs suchthere is great need for an effective POC diagnostic test for CT NGSpecific AimsThe Phase I deliverable of this project will be to validate aminute POC NAAT for CT NG in a clinical settingIn Aimroom temperature stable lyophilized reagents will be implemented on the deviceIn Aimthe sample to answer assay will be developed and validated for clinical samplesFinally in Aimthe POC test device for CT NG will be evaluated by the clinician end userin an actual clinical settingusing freshly collected patient samplesWith a projected cost of goods of under $our miniaturized molecular diagnostic device will address the need for affordable portable tests that enable accuratedetection and treatment of multiple STDs in lab freepoint of care settings PUBLIC HEALTH RELEVANCE STATEMENT Chlamydia trachomatisCTand Neisseria gonorrhoeaeNGinfections are easily cured with antibioticshowever since most cases are asymptomaticthey often go undiagnosed and untreatedUntreated infections lead to serious sequelae including pelvic inflammatory diseasePIDand its associated complicationssuch as ectopic pregnancyinfertilityand chronic pelvic painTimely diagnosis using effective point of care diagnostics and early treatment is necessaryWe propose to develop aminuteautomatedmultiplex nucleic acid amplification test for CT NG to enable rapid testing and treatment of infected individuals in a single visit