Publication demonstrates that the FDA-cleared Acuitas AMR Gene Panel detects and differentiates a wide range of 28 AMR markers that can be associated with up to 9 classes of antimicrobials Provides results at least a day earlier than methods to guide patient management and support antibiotic stewardship and infection control programs Acuitas AMR Gene Panel markers with culture “non-sensitive” results are a key differentiator
ROCKVILLE, Md., Feb. 10 10, 2022 (GLOBE NEWSWIRE) — OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and informatics to help fight infectious diseases, announced today today the publication of a new publication in a peer-reviewed journal that demonstrates that the AMR Acuitas® Gene Panel accurately detects and differentiates 28 genetic markers of antimicrobial resistance (AMR) made on isolated colonies of 26 different pathogens , including Pseudomonas aeruginosa, some members of Enterobacterales, and Enterococcus faecalis, and it associates RAM genes with nonsusceptible (i.e., intermediate, resistant) antimicrobial susceptibility (AST) results for up to 9 classes or subclasses of antimicrobials.
OpGen’s clinical trial used for FDA submission of the Acuitas AMR Gene Panel was conducted at four US study sites and included testing of 1,224 anonymized stocks created from 584 retrospectively collected isolates and 83 clinical isolates collected prospectively. Acuitas AMR Gene Panel results were compared to a combined reference standard including whole genome sequencing (WGS), organism identification, and phenotypic antimicrobial susceptibility testing using culture standard microbiological. The results of this study have now been published in the Journal of Clinical Microbiology and the authors have found that the Acuitas AMR Gene Panel is able to detect and differentiate a wide range of 28 AMR markers which can be associated with up to to 9 classes of antimicrobials from cultures of isolates of Pseudomonas aeruginosa, selected members of Enterobacterales and Enterococcus faecalis with ≥94.4% positive percent agreement (PPA) and ≥96.5% percent agreement negative (NPA) against a composite reference standard, including WGS, in just 2.5 hours.
In this publication entitled ” Multicenter Evaluation of the AMR Acuitas® Gene Panel for Detection of an Expanded Panel of Antimicrobial Resistance Genes Among Bacterial Isolates 1,” the authors note that “the association of AMR markers with non-responsive phenotypic outcomes is a key differentiator of the FDA-cleared Acuitas AMR Gene Panel from other molecular panels that simply detect the presence or absence of a gene. Associated agents include many of the most commonly prescribed antimicrobial agents, including beta-lactams, fluoroquinolones, trimethoprim-sulfamethoxazole, and aminoglycosides. The authors conclude that “this is the first commercially available, FDA-cleared diagnostic tool capable of detecting a wide range of antimicrobial resistance markers among certain Enterobacteriaceae, P. aeruginosa, and E. faecalis from of cultured isolates, with the ability to associate non-susceptible markers results for 9 classes or subclasses of antimicrobials faster than traditional phenotypic methods by at least one day to guide patient management and support treatment programs antibiotic management and infection control.
Several clinical cases illustrating the potential utility of the Acuitas AMR Gene Panel were presented during a recent webinar titled ” Explore the FDA-cleared Acuitas AMR Gene Panel: Building a Case for Clinical Utility.” The advantages of the Acuitas AMR Gene Panel over other currently available molecular testing methods were summarized by the speakers as follows: 1) AMR detection and binding to a particular organism; 2) 2.5 hour turnaround time; and 3) offering the most comprehensive RAM panel, including non-beta-lactam RAM genes, and those for what might be considered “recovery antibiotics” such as colistin. The recording of the webinar is accessible here.
A recent post 2 in The Lancet confirms the rapid spread of AMR infections and points out that approximately 4.95 million deaths were associated with AMR in 2019, and that between 2014 and 2019 the burden of deaths directly attributable to bacterial AMR fell from 700,000 to 1.27 million. The growing threat of antimicrobial resistance to public health is exacerbated by existing and newly developed antibiotics facing a wide range of drug resistance mechanisms in pathogens of concern. Recent Infectious Diseases Society of America (IDSA) treatment advice for multidrug-resistant Gram-negative bacterial infections 3 highlights how detection of AMR genes or a specific resistance mechanism can help guide practices for reporting new antimicrobial agents and tailoring treatment for these difficult-to-treat infections. Additionally, it can assist with infection prevention and control initiatives such as patient isolation procedures when multiple isolates with the same AMR profile are detected as an early indication of transmission within a facility or for the Monitoring for serious or emerging RAM threats. “The Acuitas AMR Gene Panel is a unique and powerful diagnostic tool useful in clinical patient care as well as supporting hospital infection control and epidemiology programs to identify and track AMR pathogens,” said Faranak Atrzadeh, Director of Marketing and Chief Scientific Affairs Office of OpGen.
About OpGen, Inc.
OpGen, Inc. (Rockville, MD, USA) is a precision medicine company that harnesses the power of molecular diagnostics and bioinformatics to fight infectious disease. Together with our subsidiaries, Curetis GmbH and Ares Genetics GmbH, we develop and market molecular microbiology solutions that help guide clinicians with faster, actionable insights into life-threatening infections to improve patient outcomes and reduce the spread infections caused by multidrug-resistant diseases. microorganisms or MDRO. OpGen’s product portfolio includes Unyvero®, Acuitas® AMR Gene Panel and the ARES technology platform, including ARESdb®, utilizing NGS technology and AI-powered bioinformatics solutions for antibiotic response prediction.
For more information, please visit www.opgen.com.
Forward-looking statements
This press release includes statements regarding the release of results from a recent Acuitas AMR Gene Panel study. These and other statements regarding OpGen’s future plans and objectives constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are intended to qualify for the safe harbor of liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and may cause results to differ materially from expectations. Factors that could cause our results to differ materially from those described include, but are not limited to, our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance to and commercialize our product and service offerings, the rate of adoption of our products and services by hospitals and other healthcare providers, the fact that we may not effectively utilize the proceeds of recent financings, the continued realization of the expected benefits of our business combination transaction with Curetis GmbH, the success of our marketing efforts, the continued impact of COVID-19 on the Company’s operations, financial results and marketing efforts as well as on financial markets and general economic conditions, the effect on our business of existing and new regulatory requirements, and other factors onomic and competitive. For a discussion of the most significant risks and uncertainties associated with OpGen’s business, please see our filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
OpGen: Oliver Schacht, President and CEO InvestorRelations@opgen.com
OpGen Press Contact: Matthew Bretzius FischTank Marketing and PR matt@fischtankpr.com
OpGen Investor Contact: Alyssa Factor Edison Group afactor@edisongroup.com
1 https://journals.asm.org/doi/10.1128/JCM.02098-21
2 https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02724-0/fulltext
