OpGen Completes Initial FDA 510(k) Submission for its Acuitas® AMR Gene Panel Test to Identify Presence of Antibiotic Resist...
May 14 2019 - 7:30AM
OpGen, Inc. (Nasdaq: OPGN) announced today that it has filed its
510(k) submission with the U.S. Food and Drug Administration (FDA)
for clearance for its Acuitas AMR Gene Panel test for the detection
of antimicrobial resistance genes in bacterial isolates.
The Acuitas AMR Gene Panel is a new molecular test developed
by OpGen and is designed to detect 47
antibiotic-resistance genes in less than three hours from bacterial
isolates. The test is currently available for research use only
(RUO). In addition to the isolate 510(k)
submission, OpGen is conducting clinical trials during
2019 to support a submission for its direct-from-urine Acuitas AMR
Gene Panel test and its Acuitas Lighthouse® Software for antibiotic
resistance prediction direct from clinical samples and management
of antimicrobial resistance data in healthcare institutions. These
trials will test samples collected from patients with urinary tract
infections (UTI).
“We are excited to have completed the first 510(k) submission to
the FDA for clearance of one of our Acuitas AMR Gene Panel
products, and to take the next step toward bringing our innovative
technology to the U.S. market,” said Evan Jones, Chairman and CEO
of OpGen, Inc. “The Acuitas AMR Gene Panel test for isolates
provides actionable information to help guide physician decision
making for critical care patients with acute infections. Our
Acuitas AMR Gene Panel tests are designed to help integrate
real-time epidemiologic surveillance with rapid delivery of
resistance results to care-givers via web-based and mobile
platforms. In combination with the Acuitas Lighthouse Software,
these products are intended to help rapidly identify and locate
antibiotic resistance threats in healthcare institutions and
networks.”
The performance of the Acuitas AMR Gene Panel established in the
FDA 510(k) submission is based on clinical trials where more than
1,000 clinical isolates were tested at The Johns Hopkins
University School of Medicine; Wadsworth Center, New York
State Department of Health; University Hospitals Cleveland
Medical Center; and IHMA, Inc.
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 intended 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
The statements in this press release regarding
OpGen’s future regulatory submission and clearance 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 success of our commercialization efforts,
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 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 Green Edison
Groupjgreen@edisongroup.com
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