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  1. In Vitro Diagnostics

The CDC and FDA Antimicrobial Resistance Isolate Bank

The Centers for Disease Control and Prevention and the Food and Drug Administration have collaborated to develop the AR Isolate Bank (AR Bank), a centralized repository of microbial pathogens with well-characterized antibiotic resistance profiles. The AR Bank, which contains resistant pathogenic bacteria and yeast of national medical concern, is a valuable resource to biotech and diagnostic companies to support the design, validation, and evaluation of diagnostics tests. The AR Bank is also a useful resource for drug development (e.g., antibiotics and antifungals) studies.

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 Bank includes pathogens from various specimen sources that are associated with previously known and characterized or newly emerging resistance mechanisms. Phenotypic resistance profiles, isolate characteristics and known resistance markers are available for each pathogen. In addition, users can access associated sequencing data through links provided for many isolates. As of January 2018, CDC has shipped more than 2,000 panels from the AR Isolate Bank to diagnostic test and pharmaceutical developers, academia, as well as clinical, reference, research and public health laboratories. Since the launch of the AR Isolate Bank in 2015; and as of June, 2018, the AR bank isolates have been used as challenge organisms approximately 19 diagnostic device submissions to the FDA. The following panels are currently available (as of July, 2018) in the AR Bank:

  • Enterobacteriaceae Carbapenem Breakpoint
  • Gram Negative Carbapenemase Detection
  • Enterobacteriaceae Carbapenemase Diversity
  • Vancomycin Intermediate Staphylococcus aureus
  • Pseudomonas aeruginosa
  • Acinetobacter baumannii
  • Drug Resistant Candida (species other than C. albicans)
  • Candida auris
  • Ceftolozane/tazobactam
  • Neisseria gonorrhoeae
  • Ceftazidime/avibactam
  • Isolates with New or Novel Antibiotic Resistance
  • Staphylococcus with Borderline Oxacillin Susceptibility
  • Enteric Pathogen Diversity
  • Imipenem/relebactam
  • Aminoglycoside/tetracycline Resistance

The CDC and FDA continue to collaborate on this project and the AR Bank is constantly updated with new resistant isolates/panels. Please check the AR Bank webpage for up to date information and ways to search and request isolates/panels. These isolates are available free of charge.

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