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HomeFDA UpdatesOpGen Receives FDA Clearance for Acuitas® AMR Gene Panel

OpGen Receives FDA Clearance for Acuitas® AMR Gene Panel

OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, announced today that it has received 510(k) clearance by the U.S. Food and Drug Administration (FDA) to market the Acuitas® AMR Gene Panel, and is finalizing preparations for its swift commercial launch in the U.S.

The Acuitas® AMR Gene Panel detects 28 genetic antimicrobial resistance (AMR) markers in isolated bacterial colonies from 26 different pathogens. We believe the panel provides clinicians with a valuable diagnostic tool that informs about potential antimicrobial resistance patterns early and supports appropriate antibiotic treatment decisions in this indication. The Acuitas® AMR Gene Panel expands the diagnostic capability of clinicians to rapidly and simultaneously test for select drugs in 9 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 and hence can prevent prolonged inappropriate treatment of patients. Furthermore, we believe the Acuitas® AMR Gene Panel is the first FDA-cleared molecular diagnostic panel that detects such a broad panel of AMR markers from isolates.

“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,” commented Dr. James W. Snyder, Professor of Pathology and Laboratory Medicine, and Director of Microbiology and Molecular Diagnostics, University of Louisville Hospital, KY. “The benefits of this AMR panel for predicting antibiotic resistance include the provision of genomic profile data much sooner in about 2.5 hours versus conventional phenotypic information which can take 1-4 days, supports the goal of antimicrobial stewardship, institution of infection control and prevention measures, and alerts the provider to resistant genes representing nine classes of antibiotics. In this era of “rapid diagnostics”, availability of critical information impacts all phases of the healthcare system and potentially reduces cost. AMR panel is regarded as “state of the art”, genomic-based technology.”

Indiscriminate overuse and misuse of antibiotics are key drivers of dramatically spreading antibiotic resistance, a substantial global health threat. A report recently issued1 by the Centers for Disease Control and Prevention (CDC) revealed that drug-resistant bacteria cause almost 3 million infections and 35,000 deaths a year in the United States alone, meaning that antibiotic-resistant pathogens cause a serious infection every 11 seconds and a death every 15 minutes.

By providing a fast and reliable solution for the rapid detection of antimicrobial resistance markers associated with relevant pathogens, we believe the Acuitas® AMR Gene Panel is an essential, indispensable tool for targeted antimicrobial therapy improving patient outcomes, facilitating stringent antibiotic stewardship.

“The Acuitas® AMR Gene Panel is the third molecular diagnostic panel that OpGen, as a group, has successfully received clearance for from the FDA,” commented Johannes Bacher, Chief Operating Officer of OpGen. “Along with the Unyvero® LRT and LRT BAL Application Cartridges, OpGen’s rapid testing solutions offer what we believe are the most comprehensive multiplex molecular panels for the rapid diagnosis of antimicrobial resistance in bacteria and fungi associated with life threatening infectious disease.”

“We expect that the clearance of our Acuitas® AMR Gene Panel will expand the total addressable market for this product in the U.S.,” said Oliver Schacht, PhD, President and CEO of OpGen. “It will provide us with substantial opportunities to grow our business in detecting AMR in life-threatening infections since rapid detection of antimicrobial resistance in both surveillance and diagnostic settings is still a major challenge for the clinical lab. Moreover, by providing laboratorians and clinicians with a powerful diagnostic tool to identify resistance earlier, faster and more reliably, the Acuitas® AMR Gene Panel is expected to support antibiotic stewardship efforts to avoid the unnecessary use of antibiotics.”

With commercial launch preparations well advanced, the Company expects to swiftly make the Acuitas® AMR Gene Panel for isolates broadly available to U.S. customers.


1 https://www.cdc.gov/DrugResistance/Biggest-Threats.html