AI BIOSCIENCES, INC. — Department of Health and Human Services SBIR Phase II: NIAID

Description

PROJECT SUMMARY The aim of this Phase II proposal is to develop a rapideasy to useand inexpensive multi sample diagnostic system to identify sexually transmitted infectionSTIpathogenssuch as Chlamydia trachomatisCTand Neisseria gonorrhoeaeNGin non traditional healthcare settingsThe features of our system will likely qualify it to be a CLIA waived CT NG testThe sensitivity and specificity to be achieved using this prototype type assay will be comparable with those of current laboratory based molecular testsThis would present a major advancement in clinical diagnostics for STIsAccording to the CDCchlamydia and gonorrheacaused by Ctrachomatis and Ngonorrhoeaeare the two most frequently reported STIs in the US and likely the rest of the worldThese STIs are often under diagnosedleading to delayed treatmentcontinued spread and higher public healthcare costs$billion annuallyAs a result of their prevalence and long term health consequencesthere is a need for rapid and sensitive methods of detecting STIs in order for patients to get results and treatment immediatelyIt is important that patients receive results and initial consultation or treatment during the first patient visitas they rarely return for a second visitPoint of carePOCtests are an important strategy to address the STI epidemicand because many affected by STIsyoung and or pooroften have limited access to traditional healthcarePOC tests that can be performed in non traditional settingse guniversity clinicscommunity public health care clinicsjailsand detention centerscould greatly reduce STIsThe system we propose to further develop will combine AI BiosciencesIncs novel assay cartridgelow cost automatic platform inspired byD printer technologyand a rapid real time thermal cycler to form a multisample system for use in non traditional healthcare settingsA low cost self contained nucleic acid extraction and purification cartridge will be developed to perform aminextraction process forsamplesThe extracted NA samples will then be eluted and amplified using shuttle thermal cycler to perform multiplexed real time polymerase chain reactionPCRfor CT and NG targetsmin forcyclesWe plan to optimize the assay and disposable to meet the needs of non traditional healthcare settingsimprove the system for ease of useand minimize risk of erroneous resultWe will complete prototype system validation and verification as well as determine analytical sensitivity and specificity of the CT NG assayThe proposed work will be carried out in collaboration with a STI expert in the USOur proposed technologies are highly suitable for parallelautomated processingThis is a substantial advantage over other integrated systems being developed as most can only process one sample at a timerequiring the purchase of several modules in order to meet the throughput demand in most point of care or near patient settingsThe successful development and commercialization of our medium throughput technology will impact how molecular diagnostic assays are implemented in non traditional healthcare settings