OpGen Announces Successful Completion of Clinical Trial Enrollment for Unyvero Urinary Tract Infection Panel
October 03 2022 - 7:30AM
OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision
medicine company harnessing the power of molecular diagnostics and
bioinformatics to help combat infectious disease, today announced
its successful completion of patient enrollment for its clinical
trial for the Unyvero Urinary Tract Infection (UTI) Panel.
OpGen’s Unyvero UTI Panel tests for a broad
range of bacterial and fungal pathogens as well as antimicrobial
resistance markers directly from native urine specimens. OpGen had
recently added a fourth study site in the U.S. to optimize
enrollment for different urine sample types to be included in the
study, which enabled successful collection of over 1,800 urine
samples.
“We’re excited to have completed sample
enrollment with our four clinical trial site partners as planned.
After having reached our goal of at least 1,500 prospective samples
as recommended by applicable FDA guidance, our team will now
conclude reference testing in preparation of unblinding and final
data readout, and we will start working towards a subsequent FDA
submission package,” said Johannes Bacher, Chief Operating Officer
of OpGen and Managing Director of its German based subsidiary
Curetis GmbH.
Given the complexity and comprehensive nature of the data sets,
OpGen expects to conclude data analysis in the next couple of
months. Unblinded data for each patient sample will comprise
Unyvero UTI Panel results, standard of care microbiology from the
clinical trial sites, as well as additional standardized central
microbiology data from a reference laboratory.
DisclaimerCaution - Investigational Device,
Limited by Federal (or United States) law to investigational use.
The information contained in this communication does not constitute
or imply an offer to sell or transfer any product. Performance
characteristics for this device have not yet been established and
the U.S. FDA has not yet cleared the panel.
About OpGen, Inc.
OpGen, Inc. (Rockville, MD, U.S.A.) 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 current
product portfolio includes Unyvero, Acuitas AMR Gene Panel,
and the ARES Technology Platform including ARESdb, NGS technology
and AI-powered bioinformatics solutions for antibiotic response
prediction including ARESiss, ARESid, and AREScloud, as well as the
Curetis CE-IVD-marked PCR-based SARS-CoV-2 test kit.
For more information, please visit www.opgen.com.
Forward-Looking Statements
This press release includes statements regarding
OpGen’s clinical trial for its Unyvero Urinary Tract Infection
Panel. 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, the success of our commercialization efforts, 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 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, our ability to satisfy debt
obligations under our loan with the European Investment Bank,
the effect of the military action
in Russia and Ukraine on our distributors,
collaborators and service providers, our liquidity and working
capital requirements, 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 Groupafactor@edisongroup.com
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