NEWS: pGen Introduces New RUO Rapid Test for Infection Control and Surveillance Studies
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OpGen Introduces New RUO Rapid Test for Infection Control and Surveillance Studies
GAITHERSBURG, Md., Feb. 01, 2018 (GLOBE NEWSWIRE) -- OpGen, Inc. (NASDAQ:OPGN) announced today that it has introduced a Research Use Only (RUO) Acuitas(R) AMR Gene Panel u5.47 test for commercial sale. The Acuitas AMR Gene Panel u5.47 test was developed to detect the most common bacterial causes of cUTI directly from urine (E. coli, K. pneumoniae, P. aeruginosa, P. mirabilis, E. faecalis) and isolated colonies. Additionally, the gene panel detects 47 gene targets that convey resistance to antibiotics.
The RUO AMR Gene Panel u5.47 is available for infection control purposes and pharmaceutical surveillance research as a Research Use Only test for complicated urinary tract infection (cUTI). The RUO Acuitas AMR Gene Panel u5.47 will be available while the company completes clinical trials and regulatory submissions to support U.S. Food and Drug Administration (FDA) approval for broader clinical use.
The RUO Acuitas AMR Gene Panel u5.47 detects over 600 multidrug-resistance genetic subtypes as predictors of resistance to the following antibiotic classes: Aminoglycosides, Carbapenems, Cephalosporins, Fluoroquinolones, Polymyxins, Penicillins, Sulfonamides, Trimethoprim and Vancomycin. Test results are available in under three hours compared with traditional microbiology methods, which can take two to three days to provide results.
The test has an easy-to-use protocol and reporting software designed to handle the workflow in a clinical microbiology lab environment with up to four samples per test run. The RUO Acuitas AMR Gene Panel employs industry standard PCR and DNA purification technology. Gene families detected include: KPC, NDM, VIM, IMP, OXA, CTXM-1, CTXM-9, CMY, MCR, and resistance genes to fluoroquinolone antibiotics.
Evan Jones, chairman & CEO of OpGen, stated, "The new RUO Acuitas AMR Gene Panel u5.47 was designed to improve patient outcomes and the appropriate use of antibiotics. During 2017, we have performed initial development and analytical validation of this important new technology. With initial clinical verifications underway, we are pleased to introduce the test for commercial sale for Research Use Only to hospitals for infection control purposes and for pharmaceutical surveillance studies."
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