OpGen, Inc. announced that the Centers for Disease Control and Prevention (CDC) has released updated data increasing the number of deaths in the U.S. from antibiotic-resistant bacteria and fungi and highlighting the continuing threat of rising antibiotic resistance. According to the CDC, these pathogens cause more than 2.8 million infections and 35,000 deaths in the U.S. each year. That means, on average, someone in the U.S. gets an antibiotic-resistant infection every 11 seconds, and every 15 minutes, someone dies.
The Acuitas AMR Gene Panel test, currently in development, is designed to help identify drug-resistant pathogens directly from urine as an aid in the diagnosis of urinary tract infections in under three hours. The Acuitas Lighthouse Software, also in development, is currently being tested in a state-wide initiative to help quickly identify and track urgent threat pathogens.
Evan Jones, Chairman and CEO of OpGen, commented, “We applaud the CDC for continuing to focus on the growing challenge of antimicrobial resistant (AMR) pathogens. This new report highlights that there were nearly twice as many annual deaths as the CDC originally reported in 2013, which is why we are encouraged that our Acuitas products can help address these rising threats.”
The Acuitas AMR Gene Panel (Urine) test is being developed for patients at risk for complicated urinary tract infections (cUTI) and is designed to test for up to five pathogens and up to 47 antimicrobial (AMR) genes. When paired with the Acuitas Lighthouse Software, OpGen believes the test will be able to help improve management of the more than one million patients in the U.S. with cUTI.
Specifically, the Acuitas AMR Gene Panel (Urine) test, in combination with the Acuitas Lighthouse Software, can help test for and identify major concerns for hospital patients, including Carbapenem-Resistant Enterobacteriaceae (CRE), Multidrug-Resistant (MDR) Pseudomonas Aeruginosa, and Extended-Spectrum Beta-Lactamase (ESBL) Producing Enterobacteriaceae.
OpGen is conducting clinical trials in 2019 to support a submission for the direct-from-urine Acuitas AMR Gene Panel (Urine) test and for the Acuitas Lighthouse Software for antibiotic resistance prediction for the management of antimicrobial resistance data in healthcare institutions. Earlier this year, clinical trials were conducted for establishing the performance of the Acuitas AMR Gene Panel for use with bacterial isolates. Data obtained from the clinical trials were submitted in a 510(k) submission which is currently under review by the U.S. Food and Drug Administration (FDA).
