Lucira Health, Inc. — Department of Health and Human Services SBIR Phase II: NIAID

Description

Abstract Neisseria gonorrhoeaeGCis the second most common cause of bacterial sexually transmitted diseasesSTDwith an estimated world prevalence ofmillionApproximatelycases occur annually in the U Sbut over half are unreportedand rates continue to rise as indicated by aincrease fromtoGC is a major cause of pelvic inflammatory diseasePIDthat can lead to tubal factor infertilityectopic pregnancy and chronic pelvic painGC also facilitates the transmission of HIVinfectionWhile we rely on antibiotics to treat GC infectionsempiric therapy has fueled the already problematic issue of drug resistant GC in the U Sand the worldThe main obstacle to stemming the spread of GC infections is the lack of a point ofcarePOCdiagnostic that could provide surveillance and early detectionreducing infection rates and sequelaeCurrent GC diagnostics rely on commercial nucleic acid amplification testsNAATsthat are expensiverequire equipment and highly trained operatorstake a day to days for resultsand can result in loss to follow up of patientsThuscurrent NAATs are not suitable at the POCOur team comprised of DrsDean and Gaydosexperts on STDs and POC developmentand Diassessa startup company with proprietary technology for POC diagnosticshave preliminary data showing that wecan rapidly extract GC nucleic acids from endocervical swabs with no instruments or trained operator in a prototype Sample Preparation Modulehave an instrument free multiplexed Detection Module for colorimetric detection of GC nucleic acidshave a limit of detection oforganisms assayhave validated assays to detect GC strains and assays to detect human RNA DNA with no cross reactivity with other STD pathogensandhave shown that our system can detect GC reliably in clinical endocervical swabs that are know positive by a commercial NAATWe will expand on our preliminary studies with the following aimsAimUsing the expanding aggregate of reference and clinical GC genome sequenceswe will refine our assaysreplacing failed assays as neededand ensure that our assays detect diverse GC clinical strains without cross reactivity with STD pathogens or common vaginal cervical speciesAimOptimize sample preparation chemistry for nucleic acid extraction from urethralvaginal and endocervical swabsassay design and colorimetric chemistry for these swab typeswithout false negative or positive results from interfering substancesAimWe will evaluate the sensitivity and specificityand positive and negative predictive values of our fully integrated systemthe combined Sample Preparation Module with Detection Modulecompared to commercial NAATsBy the end of Phase IIwe will be poised to manufacture and use our rapidltmininexpensiveuser friendlyinstrument freesensitive and specific GC POC test for clinical trials in the U Sto obtain FDA regulatory clearanceOur overall goal is to deploy our GC POC diagnostic for use in doctor s officessmall to large city and rural clinicsteenfamily and STD clinicsERs and hospital clinicsother testing sitesand resource constrained settings around the world