Discovering the FDA-cleared Acuitas AMR Gene Panel: Building a Case for Clinical Utility

Recently, the Infectious Disease Society of America released guidance on how to approach treatment of infections caused by multidrug-resistant organisms. The guidance highlighted the need to define mechanisms of antimicrobial resistance (AMR) to guide and tailor therapy. In this presentation, we will describe the newly FDA-cleared Acuitas AMR Gene Panel and review the multicenter diagnostic clinical trial data. The Acuitas AMR Gene Panel is a qualitative, multiplex nucleic acid‐based in vitro diagnostic test for detection and differentiation of 28 AMR markers associated with not susceptible results (i.e., intermediate or resistant) to one or more antimicrobial agents among cultured isolates of Enterobacterales, Pseudomonas aeruginosa, and Enterococcus faecalis. The Acuitas AMR Gene Panel has the potential to fill the gap that other rapid molecular tools cannot by detecting a broad array of molecular markers associated with up to 9 classes/subclasses of antimicrobials. The clinical utility of the diagnostic will be presented through a case-based format.

 

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