OpGen Provides Update on Curetis Group Business Receiving U.S. FDA 510(k) Clearance of its Unyvero LRT for BAL Specimens
23 December 2019 - 11:30PM
OpGen, Inc. (Nasdaq: OPGN) reported an update on the business
of Curetis GmbH (“Curetis”), the other party to the planned
business combination with OpGen. On December 20, 2019 Curetis
announced that the Company has received 510(k) clearance by the
U.S. Food and Drug Administration (FDA) to market its Unyvero LRT
Lower Respiratory Tract Application Cartridge for use with
bronchoalveolar lavage (BAL) samples to diagnose lower respiratory
tract infections such as pneumonia.
The LRT BAL panel detects a broad spectrum of
clinically relevant causative agents, including atypical pathogens,
as well as antibiotic resistance markers. It provides clinicians
with a valuable diagnostic tool that informs early and supports
appropriate antibiotic treatment decisions in this indication.
Infections with atypical pathogens are often
associated with community-acquired pneumonia (CAP), but are not
considered in the context of hospital-acquired or
ventilator-associated pneumonia. Hospitalized patients usually are
not tested for these organisms unless there is a suspicion of
infection. Further, empiric treatment of these patients does not
normally cover atypical pathogens. Unyvero LRT BAL expands the
diagnostic capability of clinicians to routinely identify atypical
infections that might otherwise escape detection and hence can
prevent prolonged inappropriate treatment of patients.
The Unyvero LRT BAL application is the first and
only FDA cleared molecular diagnostic pneumonia panel that includes
Pneumocystis jirovecii. As culture-based diagnosis of Pneumocystis
jirovecii Pneumonia (PJP) is not possible, identification of this
pathogen is often based on morphological detection techniques,
which are labor-intensive, time-consuming and lack sensitivity.
Rapid diagnosis of PJP, which causes severe and life-threatening
symptoms, is crucial in patients with a weak or suppressed immune
system. Initiating the appropriate therapy even one day earlier can
significantly reduce mortality in this patient group.
By providing a fast and reliable solution for
the rapid detection of pathogens and antibiotic resistance markers,
Unyvero LRT BAL is an essential, indispensable tool for targeted
antimicrobial therapy.
“We congratulate the team at Curetis for the
tremendous accomplishment of gaining FDA 510(k) clearance for its
expanded Unyvero LRT BAL product,” said Evan Jones, Chairman &
CEO of OpGen. “We believe there will be substantial opportunity
within the U.S. market for utilization of Unyvero LRT BAL for rapid
testing of suspected lower respiratory tract infections, which we
believe will help improve patient outcomes and advance antibiotic
stewardship efforts.”
OpGen and Curetis entered into a definitive
agreement to combine businesses on September 4, 2019. The closing
of the transaction under such definitive agreement has not yet
occurred and is subject to a number of significant closing
conditions, including receipt of approval from the stockholders of
OpGen, Inc. and the shareholders of Curetis, N.V. Until the
closing occurs, each of OpGen and Curetis are operating as
stand-alone businesses.
To read the full press release from Curetis, please click
here.
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 proprietary DNA
tests and informatics address the rising threat of antibiotic
resistance by helping physicians and other healthcare providers
optimize care decisions for patients with acute
infections.
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. Currently we offer
our Acuitas AMR Gene Panel tests for research use only.
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 includes statements relating
to FDA clearance of the expanded BAL claim for the Curetis LRT
test. 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 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 Group
jgreen@edisongroup.com
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