OpGen Receives FDA’s 510(k) Clearance for Acuitas AMR Gene Panel

Molecular diagnostics and bioinformatics company OpGen has received the FDA’s 510(k) clearance for its Acuitas antimicrobial resistance (AMR) gene panel, which is used to help decide which antibiotics will be most effective for patients with bacterial infections.

The panel, which can detect 28 genetic antimicrobial resistance markers in 26 different pathogens, tests for the markers to find out whether the organisms are vulnerable to select drugs in nine classes of antibiotics, including aminoglycoside, carbapenem, cephalosporin, fluoroquinolone, penicillin, polymyxin, sulfonamide, trimethoprim and vancomycin.

Rockville, Md.-based OpGen said it is now finalizing plans to launch the test in the U.S.