U.S. Patent Allowed Covering Acuitas Lighthouse® Software
October 23 2019 - 7:30AM
OpGen, Inc. (Nasdaq: OPGN) announced today that the United States
Patent and Trademark Office (the “USPTO”) has allowed a key OpGen
patent covering the Lighthouse Profiling technology used in the
company’s software for tracking antimicrobial resistant pathogens.
Patent application US 20160085912A1 “Systems, Apparatus, and
Methods for Generating and Analyzing Resistome Profiles” covers the
use of the company’s Acuitas Lighthouse® Software for real-time
monitoring of superbug infections and other multi-drug resistant
infections. The final patent is expected to be issued in the coming
weeks.
The Lighthouse Software was developed for use
with the Acuitas® AMR Gene Panel for testing bacterial isolates. In
May 2019 OpGen filed a 510(k) submission for the Acuitas AMR Gene
Panel for testing with bacterial isolates. The Acuitas AMR Gene
Panel test provides results in under three hours that can be
uploaded to the cloud in real-time for analysis using the Acuitas
Lighthouse Profiling technology. The Lighthouse software
automatically generates real-time alerts, when the degree of
similarity between pathogens is above a threshold indicating a
potential outbreak or a common source of infection such that the
patient can be contained. The Lighthouse Software is currently
available for Research Use Only and is not for use in diagnostic
procedures. The company is currently involved in a demonstration
project evaluating the use of real-time genomic profiling for
hospital and statewide surveillance to help control antimicrobial
resistance.
Evan Jones, Chairman and CEO of OpGen commented, “We are pleased
the USPTO has recognized the novelty of this key component of our
Acuitas Lighthouse Software. This is the first patent to be allowed
in a broader family of patent applications covering prediction of
antibiotic resistance and Acuitas AMR Gene Panel for rapid DNA
testing. We are preparing to deploy this technology in hospitals
throughout the United States with FDA-cleared products with a goal
of improving patient outcomes and helping to address the rise of
serious drug-resistant antimicrobial infections.”
About Antimicrobial-resistant
Infections
The Centers for Disease Control and Prevention
(“the CDC") estimates that annually in the United States we face 2
million illnesses, 23,000 deaths and $35 billion in lost
productivity – all attributable to antibiotic resistant infections.
Among the infectious diseases OpGen is 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 CREs as one of
three urgent threats to the public health.
About OpGen
OpGen, Inc. is a precision medicine company
harnessing the power of molecular diagnostics and informatics to
help combat infectious disease. We are developing molecular
information products and services for global healthcare settings,
helping to guide clinicians with more rapid and actionable
information about life threatening infections, improve patient
outcomes, and decrease the spread of infections caused by
multidrug-resistant microorganisms, or MDROs.
Our molecular diagnostics and informatics
products, product candidates and services combine our Acuitas®
molecular diagnostics and Acuitas Lighthouse® informatics platform
for use with our proprietary, curated MDRO knowledgebase. We are
working to deliver our products and services, some in development,
to a global network of customers and partners. The Acuitas AMR Gene
Panel (RUO) is available for Research Use Only and is not for
use in diagnostic procedures. The Acuitas Lighthouse Software is
not distributed commercially for antibiotic resistance prediction
and is not for use in diagnostic procedures. For more information,
please visit www.opgen.com.
OpGen, Acuitas, and Acuitas
Lighthouse are registered trademarks of OpGen, Inc.
Forward-Looking Statements
This press release describes the patent allowed
by the USPTO and OpGen’s plans with respect to its future
products. These statements 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 the future to differ materially from expectations. We
cannot assure you that there will not be a delay in the formal
issuance of the patent, that we will receive FDA clearance for our
isolates product, and future products for which we intend to submit
510(k) applications to the FDA or that our products will be adopted
by hospitals for use in treatment of antibiotic-resistant
infections. 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 Contact: Michael Farmer Vice President,
Marketing (240)
813-1284mfarmer@opgen.comInvestorRelations@opgen.com
Press Contact:Matthew BretziusFischTank
Marketing and PRmatt@fischtankpr.com
Investor Contacts: Joe GreenEdison
Groupjgreen@edisongroup.com
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