POC Diagnostic for Gonorrhea and Determination of Antimicrobial Susceptibility

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 75N93019C00019
Agency Tracking Number: N43AI190019
Amount: $300,000.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: N/A
Timeline
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
625 River Oaks Pkwy, San Jose, CA, 00009-5134
DUNS: 933894748
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 Gary Schoolnik
 (650) 521-7959
 gary.schoolnik@clickdx.com
Business Contact
 Gary Schoolnik
Phone: (650) 521-7959
Email: gary.schoolnik@clickdx.com
Research Institution
N/A
Abstract
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

* Information listed above is at the time of submission. *

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