OpGen, Inc. (Nasdaq: OPGN) reported an update on the business of
Curetis GmbH (“Curetis”), the other party to the planned business
combination with OpGen. Today, Curetis announced that it started
offering a CE-IVD certified real-time PCR test kit for SARS-CoV2
(also known as 2019-nCov), the causal pathogen of Corona Virus
Disease 2019 (Covid-19). The test kit was developed and is
manufactured by Curetis’ strategic partner BGI (Shenzhen, China)
and was cleared by Chinese authorities in January 2020. In
compliance with European regulations for in-vitro-diagnostics (IVD)
tests, the test kit was CE-IVD certified on February 28,
2020.
The BGI 2019-nCoV RT-qPCR Kit enables diagnostic
laboratories to perform SARS-CoV2 testing of nasopharyngeal swabs
and bronchoalveolar lavage fluid of patients suspected to suffer
from Covid-19. The test kit is compatible with standard methods for
extracting the virus’ nucleic acid from the sample such as the
QIAamp Viral RNA Mini Kit (QIAGEN) and can be performed on standard
real-time PCR instruments such as the Applied Biosystems 7500
Real-Time PCR System (ThermoFisher Scientific) that are available
in many molecular diagnostic laboratories in Europe. The test kit
includes all necessary reagents and controls to test up to 48
patients in just a few hours.
The test will be made available to diagnostic
laboratories in Europe through Curetis network of
distribution partners but - owing to the special circumstances of
the global SARS-CoV2 outbreak - also directly by Curetis in
countries where Curetis’ distribution partners are not set up to
supply the test kit themselves at short notices.
Offering the BGI 2019-nCoV RT-qPCR Kit is highly
synergistic with Curetis’ Unyvero product line as patients
hospitalized with Covid-19 are at risk of co-infections with
bacterial pathogens that are often resistant to one or more
antibiotics. The Unyvero HPN Panel for pneumonia allows for rapid
testing of a broad spectrum of bacterial or fungal pathogens
commonly involved in lower respiratory tract infections such as
severe and life-threatening cases of pneumonia. It also provides
key information on genetic resistance markers often carried by such
pathogens and thereby allows for earlier and better-informed
treatment decisions for hospitalized patients suffering from severe
pneumonia.
“We commend both Curetis and BGI Group for
swiftly bringing this important product to market in a time of
greatest need. As Covid-19 spreads across the globe, rapid testing
technologies will be critical to the containment and ultimate
treatment of the outbreak in Europe and beyond,” said Evan Jones,
Chairman & CEO of OpGen.
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. Until the closing occurs, each of OpGen and Curetis are
operating as stand-alone businesses.
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 the proposed business combination transaction between OpGen and
Curetis and a planned collaboration between Curetis Group company,
Ares Genetics, and BGI Group for next-generation sequencing and
PCR-based coronavirus testing in Europe. 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 and timely seek approval of, and obtain
approval of our stockholders for the transaction, satisfy the
closing conditions under the implementation agreement between OpGen
and Curetis, successfully combine the businesses of OpGen and
Curetis, comply with the complexities of a global business, achieve
the synergies we expect, successfully implement the combined
company’s strategic and business goals and objectives, and advance
our current and planned 510(k) clearance submissions with the FDA,
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.
No Offer or Solicitation
This press release is neither an offer to
purchase, nor a solicitation of an offer to sell, any securities or
the solicitation of any vote in any jurisdiction pursuant to the
proposed transactions or otherwise, nor shall there be any sale,
issuance or transfer or securities in any jurisdiction in
contravention of applicable law. No offer of securities shall be
made except by means of a prospectus meeting the requirements of
Section 10 of the Securities Act of 1933, as amended.
Additional Information and Where to Find It
In connection with the transactions contemplated
by the Implementation Agreement (the definitive agreement related
to the proposed business combination between the Company and
Curetis GmbH), a Registration Statement on Form S-4 (File No.
333-234657) has been filed with and declared effective by the
Securities and Exchange Commission (the “SEC”). Investors and
security holders are encouraged to read the registration statement
and any other relevant documents filed with the SEC, including the
proxy statement/prospectus that forms a part of the registration
statement. Such documents contain important information about
the proposed transaction. The definitive proxy statement/prospectus
was first mailed to stockholders of the Company on or about January
27, 2020. This communication is not a substitute for the
registration statement, the proxy statement/prospectus or any other
document that OpGen may send to its stockholders in connection with
the proposed transaction. Investors and security holders will
be able to obtain the documents free of charge at the SEC’s
website, www.sec.gov, or from the Company at its website,
www.opgen.com.
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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