OpGen files 510 submission with FDA for Acuitas AMR Gene Panel test
OpGen announced that it has filed its 510 submission with the FDA for clearance for its Acuitas AMR Gene Panel test for the detection of antimicrobial resistance genes in bacterial isolates. The Acuitas AMR Gene Panel is a new molecular test developed by OpGen and is designed to detect 47 antibiotic-resistance genes in less than three hours from bacterial isolates. The test is currently available for research use only. In addition to the isolate 510 submission, OpGen is conducting clinical trials to support a submission for its direct-from-urine Acuitas AMR Gene Panel test and its Acuitas Lighthouse software for antibiotic resistance prediction direct from clinical samples and management of antimicrobial resistance data in healthcare institutions. These trials will test samples collected from patients with urinary tract infections.