OpGen Achieves Key Development Milestone in Unyvero A30 RQ Platform Program
August 03 2021 - 7:30AM
OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company
harnessing the power of molecular diagnostics and bioinformatics to
help combat infectious disease, today announced that its subsidiary
Curetis GmbH and its instrument development and engineering partner
have assembled 10 final pre-series release analyzer instruments of
the Unyvero A30 RQ platform. The assembly of the instruments marks
the successful completion of a major development milestone in the
Unyvero A30 program. The A30 RQ analyzers will now proceed into
final verification and validation testing.
The Unyvero A30 RQ platform is designed to
deliver rapid and multiplexed testing results in a fully automated
sample-to-answer manner from a wide range of native clinical
specimen types. Results from simple samples such as swabs or other
simple fluids could be available in under 30 minutes, and results
from more complex native specimen might take between 45 to 90
minutes depending on assay specifics. The design of the A30 RQ
platform has been optimized to allow for multiplexing up to 33
analytes including controls from a single native sample in a fully
integrated cartridge. Given the highly flexible and versatile
design of the cartridge technology the Unyvero A30 RQ can address
various sample lysis requirements as well as testing for a wide
range of DNA and RNA nucleic acid targets. The platform has also
been designed for a competitive mix of features such as its
multiplexing and rapid time to result, broad compatibility to
different nucleic acid purification chemistry and optional
quantitative assay formats where needed, all at favorable cost of
goods for both the instrument system and the single-use
cartridges.
OpGen is evaluating a portfolio of potential
future product development programs on the Unyvero A30 RQ platform,
including rapid tests for pathogen identification for viruses,
bacteria and fungi and a broad range of antimicrobial resistance or
AMR marker panels. The portfolio is intended to complement the
existing portfolio of highly multiplexed panels on the current
Unyvero A50 platform.
Furthermore, the Unyvero A30 RQ platform can be
made available to third party development and commercialization
partners and licensees for their own assay menu and product
portfolio. The Unyvero A30 RQ platform is designed to allow
straightforward migration of third party assays using
well-established real time PCR technology. Discussions are ongoing
at this time with several potential platform partners on various
content and licensing or partnering scopes.
Andreas Boos, CTO of Curetis who is leading the
Unyvero A30 RQ platform development program overall commented,
“Despite very challenging macro environments in the global
semiconductor markets and other supply chain shortages, we have
been able to deliver the batch of 10 Unyvero A30 RQ analyzers that
are now available for a series of well-defined verification and
validation tests. The close collaboration with our instrument
development and current manufacturing partner for the first series
of A30 RQ analyzers has allowed us to keep the program on track and
to achieve this key milestone on time and according to plans.”
OpGen CEO Oliver Schacht added, “COVID-19 has
demonstrated to the world that rapid and point of care capable
platforms can deliver actionable clinical testing results in under
30 minutes where required. Having access to our own flexible and
versatile platform will allow us to expand our own product
portfolio as well as engage in strategic partnering and licensing
discussions that have the potential to leverage and monetize the
A30 RQ platform beyond what the capabilities and resources at OpGen
would allow us to do on our own.”
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
OpGen
This press release includes statements regarding
the development of OpGen’s Unyvero A30 RQ platform. These
statements and other statements regarding OpGen’s Unyvero products,
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 fact that we may not effectively use proceeds from recent
financings, the realization of expected benefits of our business
combination transaction with Curetis GmbH, 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
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:Joe
GreenEdison Groupjgreen@edisongroup.com
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