Developing a highly sensitive, rapid, handheld vaginal swab test for the detection of Chlamydia trachomatis

Project Summary Phase Diagnostics is aiming to create the new gold standard diagnostic for the detection of sexually transmitted infectionsSTIsThe company aims to replace lab based assays for Chlamydia trachomatisCTand expand testing accessibility to previously unreachable settingsThe technology combines the ease of use and very low cost of rapid point of carePOCdiagnostics with the very high accuracy of lab based testsenabling unprecedented reliability at the POC and at homeCT infection is one of the most prevalent STIs in the United StatesAn estimated three million new cases occur each year with direct annual medical costs of greater than $billionUntreated CTsymptomatic or notmay cause long term pregnancy complicationseven infertilityTraditional lab based CT assays prevent the ability to test and treat within one patient visitThis delay results in a high number of cases that do not get treatment due to loss to follow upespecially for young STI patientsand increased infection transmissionExisting rapid POC diagnostics currently fail to address these problems with sensitivities less thanPhase DiagnosticsTruSTa handheldone step True Swab Test for CT will address the market s demands with four key characteristicsFastResults to the patient in less thanminutesAffordableCosts less than $to manufactureAccurateSensitivity and specificity on par with lab based assaysConvenientHandheld with no required equipment or trainingTruST is one of the only products that combines the advantages of all testing optionsallowing us to enter testing settings unreachable to existing diagnosticsThe key innovation is to use aqueous two phase systemsATPSsto selectively pre concentrate the pathogenic bacteria prior to detectionthereby dramatically enhancing the accuracy of conventional rapid LFA POC technology and enabling the use of vaginal swabs for the detection of CTPhase I of the project will involve developing a low riskeasier to achieve two step deviceand a high riskhigh reward one step diagnosticWe will use vaginal swab samples collected in STI clinics to evaluate the feasibility of the two approachesand the one that achieves superior sensitivity and specificity will be further investigated in Phase IISuccessful completion of Phase I will result in finalized diagnostic components for prototyping and evaluation in Phase IIPhase II of the project will consist of developing a prototype of our TruST deviceSmall scale manufacturing will be established to ensure a pilot lot can be manufactured with high precisionThe manufactured pilot lot will then be used for Alpha and Beta product testing where the devices will be sent to multiple clinical sites for on site evaluation by cliniciansSuccessful completion of Phase II will result in a device ready for FDAkclearance and CLIA waiver enabling clinical studies