The FDA-CDC Antimicrobial Resistance Isolate Bank
The Food and Drug Administration and the Centers for Disease Control and Prevention have collaborated to develop the AR Isolate Bank, a centralized repository of microbial pathogens with well-characterized resistance profiles. The bank, which contains bacterial pathogens of national medical concern, will provide a valuable resource to biotech and diagnostic groups in researching, designing, validating and evaluating next generation clinical tests, which in turn may support earlier diagnosis and development of more effective treatment options that can slow antibiotic resistance.
In vitro diagnostic device companies and antimicrobial susceptibility test manufacturers seeking FDA approval or clearance for certain infectious disease diagnostic devices may find the isolates in this bank useful as challenge pathogens during their premarket studies, though the FDA will accept premarket studies that use well-characterized isolates from other sources.
The AR Isolate Bank includes collections of bacterial pathogens that are associated with known or emerging resistance mechanisms. Available for each pathogen are susceptibility information and/or resistance profiles, known resistance markers, isolate characteristics, and other associated data. Three isolate panels are currently available, representing more than 160 total pathogens.
- Enterobacteriaceae Carbapenem Breakpoint Panel
- Gram Negative Carbapenemase Detection Panel
- Enterobacteriaceae Carbapenemase Diversity Panel
These isolates are available free of charge. Manufacturers can request the isolates through the FDA-CDC AR Isolate Bank webpage.