OpGen Announces CE-IVD Marking and Commercial Launch in Europe of its Own Developed Molecular Diagnostic SARS-CoV-2 Kit with ...
August 20 2020 - 7:30AM
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 its subsidiary
Curetis GmbH has obtained the CE mark certification in the European
Union for its own SARS-CoV-2 Kit with PULB for the detection of
SARS-CoV-2, the virus that causes COVID-19.
Developed and manufactured by Curetis’ team in
Germany, the SARS-CoV-2 Kit with PULB uses real-time reverse
transcription polymerase chain reaction (RT-PCR) technology for
qualitative detection of the SARS-CoV-2 virus isolated from
oropharyngeal and nasopharyngeal swab specimens from individuals
suspected of COVID-19 by their healthcare provider or for screening
of asymptomatic individuals. This kit can be used with RNA isolated
by performing standard RNA isolation processes, as well as with
oropharyngeal or nasopharyngeal swabs collected in PCR compatible
viral transport medium treated with PCR-Compatible Universal Lysis
Buffer (PULB) provided in the kit. Including PULB in the kit as a
workflow option allows labs to circumvent the need for extraction
equipment and extraction kits/reagents, thereby providing
operational and workflow efficiencies, time and cost savings. The
kit is designed to provide time to results in approximately one
hour, and it runs on open real-time PCR instruments such as the
QuantStudio™ 5 Real-Time PCR System and the Bio-Rad CFX96™
Real-Time PCR Detection System.
“The CE-IVD Marking is an important step in
advancing our efforts to support critical COVID-19 testing; the
Curetis SARS-CoV-2 Kit with PULB provides additional testing
capacity in countries that recognize the CE Mark to test patients,”
said Johannes Bacher, COO of OpGen.
“By launching this new product in Europe, we are
committed to helping our distributors and customers to expand the
availability of SARS-CoV-2 diagnostic testing, and our
own-developed CE-IVD marked SARS-CoV-2 Kit with PULB is expected to
help increase availability of these much-needed tests," said Oliver
Schacht, PhD, CEO of OpGen. “Our customers will benefit from an
optimized workflow and a test that delivers great performance and
significantly shorter time-to-result at favorable economics
compared to many of the commercially available open PCR platform
COVID-19 tests including the BGI SARS-CoV-2 kit. Having access to
our own SARS-CoV-2 kit allows us to have that product distributed
rather than the BGI test kit which we will cease distributing
effective immediately.”
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 by
OpGenThis press release includes statements regarding the
commercial launch of a SARS-CoV-2 Kit by OpGen’s subsidiary,
Curetis GmbH. These statements and other statements regarding
OpGen’s SARS-CoV-2 test kits, their commercialization and launch,
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 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 realization of
expected benefits of our business combination transaction with
Curetis GmbH, 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:Oliver
SchachtCEOInvestorRelations@opgen.com
Press Contact:Matthew
BretziusFischTank Marketing and PRmatt@fischtankpr.com
Investor Contact:Megan
PaulEdison Groupmpaul@edisongroup.com
Source: OpGen, Inc.
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