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.
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 Acuitas®
Lighthouse, 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
OpGen’s Acuitas® AMR Gene Panel for Isolates and clearance with the
U.S. FDA. 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 financings, the realization of expected benefits of
our business combination transaction with Curetis GmbH, the success
of our commercialization efforts, the 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:Joe Green Edison
Group jgreen@edisongroup.com
1 https://www.cdc.gov/DrugResistance/Biggest-Threats.html
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