OpGen receives clearance for AMR test panel

Oct. 5, 2021

OpGen, based in Rockville, MD, announced that it has received 510(k) clearance by the U.S. Food and Drug Administration (FDA) to market the Acuitas AMR Gene Panel.

The Acuitas AMR Gene Panel detects 28 genetic antimicrobial resistance (AMR) markers in isolated bacterial colonies from 26 different pathogens. The panel expands the diagnostic capability of clinicians to rapidly and simultaneously test for select drugs in nine classes of antibiotics — including aminoglycosides, carbapenems, cephalosporins, fluoroquinolones, penicillins, polymyxins, sulfonamides, trimethoprim, and vancomycin — to aid in the identification of potentially antimicrobial-resistant organisms that might otherwise escape detection. This can help prevent prolonged inappropriate treatment of patients.

James W. Snyder, Professor of Pathology and Laboratory Medicine, and Director of Microbiology and Molecular Diagnostics, University of Louisville Hospital, KY, said, “Overcoming the challenges associated with antibacterial resistance begins with an understanding and knowledge of the pathogen’s genetic profile, especially a profile of relevant resistant genes they harbor.”

The company said it expects to swiftly make the Acuitas AMR Gene Panel for isolates broadly available to U.S. customers.

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