OpGen Extends and Expands Partnership with New York State Department of Health to Detect Antimicrobial-Resistant Infections
April 19 2021 - 7:30AM
OpGen, Inc. (Nasdaq: OPGN) announced
today that its strategic collaboration with the New York State
Department of Health (“DOH”) to develop a state-of-the-art
solution to detect, track, and manage antimicrobial-resistant
infections at healthcare institutions statewide is being extended
beyond the second-year expansion phase by another six months
through September 30, 2021.
Having successfully achieved all of the
milestones of the first and second year phases for the development
of an infectious disease digital health and precision medicine
platform that connects healthcare institutions to DOH and uses
genomic microbiology for statewide surveillance and control of
antimicrobial resistance, OpGen will continue to work
together with DOH’s Wadsworth Center and the participating
healthcare systems to expand the reach of the platform, increase
the volume of testing, and enhance data collection. Due to the
COVID-19 pandemic which had slowed down testing throughout much of
2020, the extension and expansion phase allows all stakeholders to
generate significantly more data as testing volumes have been
increasing substantially from fall of 2020 month by month until the
end of March 2021 to date.
The DOH, OpGen, and all stakeholders will
continue to work collaboratively to demonstrate that a sustainable,
flexible infectious diseases reporting, tracking and surveillance
tool for antimicrobial resistance can be applied across New
York State. The six-month extension and expansion phase will build
on the successes and experience of the first two years while
focusing on accomplishing the goal of this visionary effort to
improve patient outcomes and save healthcare dollars by integrating
real-time epidemiologic surveillance with rapid delivery of
antibiotic resistance results to care-givers via web-based and
mobile platforms. OpGen is providing its
Acuitas® AMR Gene Panel for rapid detection of
multidrug-resistant bacterial pathogens along with its Acuitas
Lighthouse® Software for high resolution pathogen tracking. The
six-month extension and expansion contract includes a quarterly
retainer-based project fee as well as volume-dependent per test
fees for a total contract value of up to an
additional $540,000 to OpGen, which includes unused
budget resources from the second-year phase.
“We are excited and grateful that despite the
continued COVID-19 pandemic, the Department of Health of New
York State and the Wadsworth Center continue to work with us
and have expanded their partnership beyond the second year, adding
another up to 1,680 AMR Gene Panel tests to be run,”
commented Oliver Schacht, CEO of OpGen. “The quick spread
of antimicrobial resistant superbugs across healthcare systems is
the silent pandemic hidden underneath the current COVID-19
pandemic. We anticipate that with our innovative diagnostic
solutions we will be able to proactively identify such pathogens
leading to early intervention and lifesaving treatment. This six
month extension period gives us the time to also discuss and
evaluate potential future forms of collaboration with the NYS DOH
across the state.”
The precision medicine solutions provided
by OpGen to accomplish the project goals are:
-
The OpGen Acuitas AMR Gene Panel, a rapid diagnostics platform
capable of detecting and identifying multidrug-resistant bacterial
pathogens in under three hours and for use with the Acuitas
Lighthouse Software. Together, these products can help to rapidly
identify and locate antibiotic resistance threats in healthcare
institutions and networks. Both systems are commercially available
for Research Use Only (RUO) and the Acuitas AMR Gene
Panel for use with bacterial isolates is pending an expected
FDA clearance decision as soon as practicable given FDA’s staffing
resource constraints.
-
The OpGen Acuitas Lighthouse Software includes Acuitas
Lighthouse epidemiology dashboards with high-resolution pathogen
tracking through healthcare facilities, to cities, regions, as well
as the entire state.
Wadsworth Center Deputy Director Dr. Victory
Derbyshire said, “Under Governor Cuomo's leadership New
York State continues to lead the nation in addressing the
threat of antimicrobial resistance. Working with our private-sector
partners, the Wadsworth Center is able to further advance our
mission to improve the public health of all New Yorkers.”
About Antimicrobial-resistant
Infections
The Centers for Disease Control and
Prevention estimates that annually in the United
States we face 2.8 million infections with 35,000 deaths
and $49 billion in lost productivity – all
attributable to antibiotic resistant infections. Among the
infectious diseases the parties are working to address are
carbapenem-resistant Enterobacteriaceae (CRE) bacteria; they are
untreatable and hard-to-treat infections on the rise among patients
in medical facilities. CREs have become resistant to all or
nearly all the antibiotics we have today. Almost half of
hospital patients who get bloodstream infections from CRE bacteria
die from the infection. The CDC has classified CRE’s
as one of three urgent threats to the public health.
About Wadsworth Center
Laboratories
The Wadsworth Center laboratories stand at the
forefront of biomedical and environmental sciences and their
interplay. The Center serves a vital role in the New York
State Department of Health’s efforts to protect and promote
the health of New York’s citizens. Building on more than a century
of excellence as the state’s public health laboratory, the Center
continues as a premier biomedical institute that merges clinical
and environmental testing with fundamental, applied and
translational research. Today, Wadsworth Center scientists use both
classical and contemporary approaches to study environmental and
biological questions related to human health and disease. They
develop advanced methods to identify microbial or chemical threats;
study drug resistance, emerging infections, and environmental
exposures; manage the country’s most comprehensive diagnostic and
environmental testing laboratory permit program; oversee extramural
research programs on stem cells, breast cancer and spinal cord
injury; and train the next generation of scientists through
undergraduate, graduate, postdoctoral and visiting scientist
programs.
About OpGen, Inc.
OpGen, Inc. (Gaithersburg, MD, USA) is a
precision medicine company harnessing the power of molecular
diagnostics and bioinformatics to help combat infectious disease.
Along with 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 collaboration with the NYS DOH Wadsworth Center. 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, including our November 2020 private placement, February
2021 Registered Direct and March 2021 warrant exercise and
exchange, 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:Megan Paul Edison
Group mpaul@edisongroup.com
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