Visby Medical, Inc. — Department of Health and Human Services SBIR Phase I: NIAID

Description

VisbyFormally know as Click Diagnosticshas developed a PCR based rapiddisposablepoint of care test that automatically performs sample processingPCR amplificationand amplicon detectionLeveraging the existing platformClick willfrom a single urogenital sampledetect NG and determine whether the infecting strain is susceptible to three classes of antibioticsciprofloxacincefiximeor a novel antibiotic zoliflodacinBecause of the gonococci s ability to become resistant to almost every recommended antibioticonly one therapy is currently recommended by the CDCdual treatment with injectable ceftriaxone and oral azithromycinthough reduced susceptibility has been observed for bothBy determining the genotype of the infecting strainWT gyraseA Serciprofloxacin susceptibleor penA mosaic XXXIVreduced cefixime susceptibilitywe will be providing individualized treatment to patientsthus minimizing the use of ceftriaxoneAdditionallyby detecting zoliflodacin resistant genotypesgyraseB DN KT SNwe now have a companion diagnostic for this novel class of antibioticIn Phase IClick has partnered with DrJeffrey KlausnerUCLAto develop and test a multiplexed antimicrobial susceptibility assay to detect single nucleotide polymorphisms that confer susceptibility resistance to ciprofloxacincefiximeand zoliflodacinThe new assay will retain similar specificitysensitivityPCR efficiencyand limits of detectioncfu mlas our current NG opaA assay