OpGen Announces Publication of Results from the Acuitas AMR Gene Panel Multicenter Clinical Trial in the Journal of Clinical Microbiology
February 10 2022 - 3:30PM
OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company
harnessing the power of molecular diagnostics and informatics to
help combat infectious disease, announced today the release of a
new peer-reviewed journal publication that demonstrates that the
Acuitas® AMR Gene Panel accurately detects and differentiates 28
genetic antimicrobial resistance (AMR) markers performed on
isolated colonies from 26 different pathogens including Pseudomonas
aeruginosa, select members of Enterobacterales, and Enterococcus
faecalis, and it associates AMR genes with not susceptible (i.e.
intermediate, resistant) antimicrobial susceptibility (AST) results
for up to 9 antimicrobial classes or subclasses.
OpGen’s clinical trial used for the FDA
submission of the Acuitas AMR Gene Panel was conducted at four U.S.
study sites and included testing of 1,224 de-identified stocks
created from 584 retrospectively collected isolates and 83
prospectively collected clinical isolates. The Acuitas AMR Gene
Panel results were compared with a combined reference standard
including whole genome sequencing (WGS), organism identification
and phenotypic antimicrobial susceptibility testing using standard
of care microbiology culture. The results of this study have now
been published in the Journal of Clinical Microbiology and the
authors found that the Acuitas AMR Gene Panel is capable of
detecting and differentiating a broad range of 28 AMR markers that
can be associated with up to 9 antimicrobial classes from cultured
isolates of Pseudomonas aeruginosa, select members of
Enterobacterales, and Enterococcus faecalis with ≥ 94.4% Positive
Percent Agreement (PPA) and ≥ 96.5% Negative Percent Agreement
(NPA) as compared with a composite reference standard, including
WGS, in just 2.5 hours.
In this publication titled “Multicenter
Evaluation of the Acuitas® AMR Gene Panel for Detection of an
Extended Panel of Antimicrobial Resistance Genes among Bacterial
Isolates1,” the authors note that “associating the AMR markers with
not susceptible phenotypic results is a key differentiator of the
FDA-cleared Acuitas AMR Gene Panel compared to other molecular
panels that simply detect the presence or absence of a gene.” The
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 FDA-cleared commercially available
diagnostic tool that is capable of detecting a broad array of AMR
markers among select Enterobacterales, P. aeruginosa and E.
faecalis from cultured isolates, with the ability to associate
non-susceptible results for 9 antimicrobial classes or subclasses
more rapidly than traditional phenotypic methods by at least a day
to guide patient management and support antibiotic stewardship and
infection control programs.”
Several clinical cases illustrating the
potential utility of the Acuitas AMR Gene Panel were presented
during a recent webinar titled “Discovering 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 test methods were summarized by the speakers,
as follows: 1) AMR detection and linkage to a particular organism;
2) turnaround time of 2.5 hours; and 3) offering the most
comprehensive AMR panel, including non-beta-lactam AMR genes, and
those for what might be considered “salvage-therapy antibiotics”
such as colistin. Recording of the webinar can be accessed
here.
A recent publication2 in The Lancet confirms the
rapid spread of AMR infections and highlights that, an estimated
4.95 million deaths were associated with AMR in 2019, and between
2014 and 2019, the burden of fatalities directly attributable to
bacterial AMR rose from 700K to 1.27M. The growing threat of AMR 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 guidance for multidrug-resistant Gram-negative
bacterial infections3 highlights how detection of AMR genes or a
specific mechanism of resistance can help guide reporting practices
for novel antimicrobial agents and tailor therapy for these
difficult to treat infections. Furthermore, it can help 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 surveillance of serious or emerging AMR threats.
“The Acuitas AMR Gene Panel is a unique and powerful diagnostic
tool useful in clinical patient care as well as in support of
hospital infection control and epidemiology programs to identify
and track AMR pathogens,” said Faranak Atrzadeh, Chief Marketing
and Chief Scientific Affairs Office of OpGen.
About OpGen, Inc.
OpGen, Inc. (Rockville, MD, USA) is a precision
medicine company harnessing the power of molecular diagnostics and
bioinformatics to help combat infectious disease. Along with our
subsidiaries, Curetis GmbH and Ares Genetics GmbH, we are
developing and commercializing molecular microbiology solutions
helping to guide clinicians with more rapid and actionable
information about life threatening infections to improve patient
outcomes, and decrease the spread of infections caused by
multidrug-resistant microorganisms, or MDROs. OpGen’s product
portfolio includes Unyvero®, Acuitas® AMR Gene Panel and the ARES
Technology Platform including ARESdb®, using 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 publication of results of a recent study of the Acuitas AMR
Gene Panel. These statements and other statements regarding OpGen’s
future plans and goals 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 from 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 which 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 for
and commercialize our product and services offerings, the rate of
adoption of our products and services by hospitals and other
healthcare providers, the fact that we may not effectively use
proceeds from recent financings, the continued realization of
expected benefits of our business combination transaction with
Curetis GmbH, the success of our commercialization efforts, the
continued impact of COVID-19 on the Company’s operations, financial
results, and commercialization efforts as well as on capital
markets and general economic conditions, the effect on our business
of existing and new regulatory requirements, and other economic and
competitive factors. For a discussion of the most significant risks
and uncertainties associated with OpGen's business, please review
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 SchachtPresident and
CEOInvestorRelations@opgen.com
OpGen Press Contact:Matthew
Bretzius FischTank Marketing and PR
matt@fischtankpr.com
OpGen Investor Contact:Alyssa
FactorEdison
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
3 https://pubmed.ncbi.nlm.nih.gov/33106864/
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