The Genie II System to Support VetLIRN Investigations

NIH RePORTER · FDA · U18 · $18,027 · view on reporter.nih.gov ↗

Abstract

CDC has declared the complex problem of antimicrobial resistance (AMR) in bacteria a serious public health threat. 1 Aggressive action is needed to prevent the spread of AMR bacteria and surveillance is necessary to detect new resistance mechanisms. To combat AMR, the CDC has identified 4 core actions: Preventing Infections and the Spread of Resistance, Disease Surveillance, Antibiotic Stewardship and Development of New Diagnostics, all of which can be addressed through rapid molecular diagnostics. In 2012, FDA announced the Cooperative Agreement PA-12-194 CVM Vet-LRN Veterinary Diagnostic Laboratory Program - (U18). The program has been an unqualified success, as highlighted in the recent FVM Research Impact: Advancing Public Health through Regulatory Science publication.2 The VetLIRN program was highlighted as advancing public health and as an integral part of the team working to slow the emergence of resistant bacteria and prevent the spread of resistant infections. The emergence of Carbapenem resistant Enterobacteriaceae (CRE) in companion animal veterinary medicine was inevitable – and yet we were, and are, completely unprepared. CRE are regarded by the CDC as an urgent public health threat because they are not only carbapenem resistant but are resistant to most other antibiotic classes. To date there have been a few sporadic reports of CRE from dogs.3-10 Although the prevalence of CRE has risen significantly in human healthcare settings over the past few years we currently have no data on the community population prevalence of CRE colonization in dogs and cats. VetLIRN has created a Veterinary Antimicrobial Working Group (VAWG) to navigate the complex issues associated with the isolation of these organisms from animals. The purchase of a Genie II System would very effectively increase our capacity to be fully engaged with the VetLIRN AST and VAWG projects and begin the development of isothermal amplification assays to rapidly detect CRE/CPOs at the point of care. The Genie II System will also be used in Vet-LIRN investigations as assays have already been developed for other pathogens such as Salmonella. Case investigations frequently include pathogen detection, identification, and characterization of antibiotic resistance of clinical isolates.

Key facts

NIH application ID
10144864
Project number
1U18FD006985-01
Recipient
UNIVERSITY OF PENNSYLVANIA
Principal Investigator
SHELLEY CATHERINE RANKIN
Activity code
U18
Funding institute
FDA
Fiscal year
2020
Award amount
$18,027
Award type
1
Project period
2020-08-01 → 2021-07-31