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 Ares Genetics
GmbH, a Curetis Group company, and the Chinese genomics company BGI
Group will collaborate in making molecular testing for the new
coronavirus 2019-nCoV available in Europe.
2019-nCoV is a new coronavirus variant that has
not been previously identified in humans but is responsible for the
outbreak originating in the Chinese city of Wuhan and rapidly
spreading globally with first cases identified and confirmed in
Europe already. In response to this situation, and immediately
after the occurrence of unexplained pneumonia in Wuhan on December
31, 2019, BGI was first to sequence the genome of the new 2019-nCoV
virus and successfully developed a Real-Time (RT) Fluorescent PCR
(polymerase chain reaction) kit for detecting 2019-nCoV, which can
provide results in a few hours and has already obtained approval by
the Chinese National Medical Products Administration.
In addition to the rapid detection kit based on
RT-PCR technology, the DNBSEQ-T7 sequencing platform developed by
BGI Group’s instrument and reagent subsidiary, MGI, passed the
emergency approval procedure of the National Medical Products
Administration, becoming the first officially approved testing
products in China for surveillance, discovery and identification of
unknown infectious diseases.
In Europe, BGI and MGI will work with their
long-term strategic partner Ares Genetics to make its 2019-nCoV
testing portfolio available to public health institutions and
hospitals for outbreak monitoring, infection control, and
epidemiology. Ares Genetics expects to provide next-generation
sequencing services for 2019-nCoV out of its NGS laboratory in
Vienna, Austria, for infection control and tracking of pathogen
evolution from February 2020 onwards based on MGI’s DNBSEQ
sequencing platform. Further, Ares Genetics and the Curetis Group
will support BGI Group in the distribution of its PCR and NGS
reagent kits to molecular testing laboratories in Europe that have
the capability for 2019-nCoV testing with reagent kits initially
being marketed for research use only prior to regulatory approval
in Europe.
Ares Genetics is a digital diagnostics company
utilizing artificial intelligence-powered molecular diagnostics to
advance the field of infectious disease testing. Ares Genetics
recently launched ARESupa – Universal Pathogenome Assay for the
broad identification of bacterial pathogens and the accurate
prediction of antibiotic susceptibility. The ARESupa test is based
on the sequencing of bacterial DNA, combined with data analysis and
interpretation powered by ARESdb, Ares Genetics’ unique,
proprietary reference database on genetic antimicrobial resistance
markers. The first generation of ARESupa is currently offered for
non-diagnostic applications in epidemiology, infection control, and
outbreak analysis for customers in the public health sector and the
pharmaceutical industry. A laboratory-developed test (LDT) for
human diagnostic use is under development.
“This collaboration highlights the importance of
rapid testing technologies in tracking the evolution of and
containing global outbreaks. We congratulate Curetis on their
collaboration and commend them and BGI Group for their swift action
to assist in the surveillance and identification of yet another
infectious disease with cases across the globe,” 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. and the shareholders of Curetis, N.V. 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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