LYNNTECH INC. — Department of Health and Human Services SBIR Phase I: NIAID

Description

PROJECT SUMMARY Gonorrhea is caused by the bacterium Neisseria gonorrhoeae and is the second most reported sexually transmitted infectionSTIin the worldIf left untreatedcomplications may include pelvic inflammatory diseasenewborn blindnessinfertility and increased risk of infection by other STDsincluding HIVThe Centers for Disease Control and PreventionCDCestimates thatnew gonococcal infections occur in the U Seach year withamong young peopleyears oldMedications to treat gonorrhea have been around for decades but the organism has grown resistant to virtually every medication used to treat itThe CDC recommends treatment changes when surveillance data indicate aresistance to the class of antimicrobial being used at the timeCurrentlydual treatment with ceftriaxonecephalosporinwith azithromycinmacrolideare recommendedSince treatment recommendations are based onresistancemost circulating isolates appear to still be sensitive to previously recommended antimicrobialsRe introducing these antimicrobials into clinical use may allow for the continued successful treatment of gonorrhea even if cephalosporin resistance becomes widespreadCulture based agar dilution tests are the gold standard for determining the susceptibility of Ngonorrhoeae to antibioticsHoweverit is unacceptably slowdaysand laboriousFaster genotypic approaches are available that involve the detection of gene mutations known to confer resistancee gNGSNPHoweverthese approaches are limitingas they require prior knowledge of resistance mechanismsTo select the most effective therapyantimicrobial susceptibility diagnostics are needed to characterize phenotypes of infecting Ngonorrhoeae strainsThese tests can guide treatment at the point of carePOCand facilitate antibiotic stewardshipLynntech is proposing to develop a test based on the molecular responses of Ngonorrhoeae to antibiotic exposureMolecular responses upon exposure to antibiotics can be detected long before phenotypic changes in growth can be observedMeasuring molecular changes in Ngonorrhoeae to antibiotic exposure will provide a rapid test that can be performed at the POCsuch as a clinicLynntech s assay will be rapidhourand will be able to identify Ngonorrhoeae as well as determine the susceptibility of the infecting strain to at least three classes of antibioticsquinolonesmacrolidescephalosporinsdirectly from the patient samplee gurineurethral vaginal cervical swabOur assay will be self containedrequire minimal hands on time and will provide easy to interpret results for the clinician PROJECT NARRATIVE Lynntech s diagnostic assay will provide phenotypic information about corresponding drug susceptibility and or drug resistance that will inform clinical therapeutic approachesThis assay will also provide pathogen identityUsing this informationdoctors can help to combat the resistance crisis by selecting appropriate and tailored therapiesreducing the misuse of antibiotics