OpGen Announces Successful Completion of Unyvero A30 Development Milestone
February 10 2022 - 6:30AM
OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company
harnessing the power of molecular diagnostics and informatics to
help combat infectious disease, announced today that its subsidiary
Curetis has successfully met a key milestone in the development of
the new Unyvero A30 RQ platform instruments. Over the course of the
last several months the A30 RQ instruments were put through a
rigorous process of final verification and validation (V&V)
testing. These tests were designed and conducted per the applicable
guidelines and recommendations, including IEC 61010/UL 61010 for
instrument safety, IEC 61326 for electromagnetic compatibility and
interferences and EN 60086 for transport, storage and operational
conditions.
The performed V&V tests included testing of
mechanical and electrical safety, radiated and conducted electrical
emissions and interference, mechanical robustness when exposed to
mechanical shock and vibration, heat, cold, humidity and other
environmental factors. The Unyvero A30 RQ instruments were put
through these tests at a number of external sites and facilities
including CSA Group Europe GmbH at their German headquarter test
facility, Zollner Elektronik AG, and ELMAC EMC/EMI test labs, and
environmental testing lab of TELUS GmbH in Germany. All test
reports have now been completed. Complementing the V&V testing
efforts, the Curetis team also put the Unyvero A30 RQ through a
rigorous schedule of lifetime testing of all relevant mechanical
instrument components, including all moving parts, cartridge
loading/unloading mechanics, Peltier heaters and coolers for
reaction chambers, and PCR ultrafast temperature cycling and
long-term operation of the integrated hose pump. Some of these
tests included tens to hundreds of thousands of repetitions to
ensure that the instruments were tested well in excess of their
expected lifetime usage. The PCR Peltier element as the most
critical part was tested for almost 1 million PCR cycles at the
highest possible ramp rates of 10 K/sec creating the most stringent
stress conditions for the element. All these tests passed
successfully.
Andreas Boos, CTO of OpGen’s subsidiary Curetis
commented: “In my over 30 years of engineering and platform
development experience in the medical device and diagnostics
industry I have never before seen a final instrument V&V
program being completed with such flying colors. All findings were
minor and we have been able to address all of them and mitigate
them for the final series production release of the Unyvero A30
systems.” Andreas Boos added that “this effectively has also
allowed us to upgrade to final product specs the ten prototype
instruments that we had received in summer of 2021 and use them for
further development of the platform including assay development and
clinical V&V work going forward.”
Oliver Schacht, CEO of OpGen indicated that
“this success in meeting this final key milestone in the Unyvero
A30 instrument development now enables us to move into final
product design and to get a first set of series-ready instruments
built. In parallel, we expect to work on our first A30 cartridge
application and look forward to bringing the platform into its
first clinical trial later in 2022. Such trial data would then be
aimed at future regulatory submission and clearance by the U.S.
Food and Drug Administration. Having the A30 ready for clinical
trials and subsequent commercialization will also be key to any
partnering and licensing conversations going forward.”
About OpGen, Inc.
OpGen, Inc. (Rockville, MD, USA) is a precision
medicine company harnessing the power of molecular diagnostics and
bioinformatics to help combat infectious disease. Along with our
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 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
This press release includes statements regarding
the completion of the Unyvero A30 development milestone and the
continued development of the instruments. 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 fact that we may not effectively use proceeds from recent
financings, the continued realization of expected benefits of our
business combination transaction with Curetis GmbH, the success of
our commercialization efforts, the continued 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:Oliver SchachtPresident and
CEOInvestorRelations@opgen.com
OpGen Press Contact:Matthew
Bretzius FischTank Marketing and PR
matt@fischtankpr.com
OpGen Investor Contact:Alyssa
FactorEdison
Group afactor@edisongroup.com
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