OpGen Announces Interim Analysis Results from Clinical Trial for Unyvero Urinary Tract Infection Panel
April 05 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, reported today
that, following the successful completion of a reproducibility
study earlier this year, it has now unblinded and analyzed a
limited data set comprising of the first 150 prospectively enrolled
U.S. patient samples. Clinical trial enrollment continues at all
sites.
OpGen’s Unyvero Urinary Tract Infection (UTI)
Panel tests for a broad range of pathogens as well as antimicrobial
resistance markers directly from native urine specimens. The
clinical performance evaluation, which aims at a subsequent FDA
submission, includes a prospective multicenter trial at three U.S.
sites.
The objective of the interim analysis was to
confirm the absence of significant performance variations in
results between the testing sites, and to furthermore confirm that
blinded data collection across all data sources and study
participants is executed as planned.
“We’re pleased to see that the clinical trial
protocol has been implemented as planned across the different
participating trial sites,” said Johannes Bacher, COO of OpGen,
Inc. and Managing Director of German based Curetis GmbH. “Based on
our preliminary analysis of the different data sources generated
for this limited sample set, we have decided to continue enrollment
towards our study goal of 1,500 prospective samples without any
changes. We will furthermore include archived urine samples in
order to complement the study data with additional data points for
rare pathogens and antibiotic resistance markers.”
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, 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 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
This press release includes statements regarding
the interim analysis results of OpGen’s clinical trial for its
Unyvero Urinary Tract Infection. 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, 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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