OpGen Announces Positive Top Line Data from Clinical Trial for Unyvero Urinary Tract Infection Panel
December 13 2022 - 6:30AM
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
top line data from its successfully completed Unyvero UTI clinical
trial. OpGen’s Unyvero UTI Panel tests for a broad range of
bacterial and fungal pathogens as well as antimicrobial resistance
markers directly from urine specimens. The test aims at
quantitative detection of microorganisms.
The trial was designed to compare the
performance of the Unyvero UTI Panel for detecting urinary tract
infections (UTI), using clean-catch or catheter related urine
samples. Preliminary analysis of all prospectively enrolled samples
showed that the primary study endpoint was successfully met by
demonstrating an overall weighted average sensitivity of 96.4% and
overall weighted average specificity of 97.4% when compared against
each trial site’s standard of care microbiology results. These
findings are also in line with the interim analysis performed
during the first part of the trial.
The trial included a total of 1,858 prospective
and archived samples and has run over 3,300 Unyvero cartridges,
including controls and reproducibility tests performed at the
different trial sites. In addition to local microbiology laboratory
results and additional standardized central microbiology data from
an independent reference laboratory, OpGen is currently generating
next-generation sequencing (NGS) data at its Rockville, MD, lab
facility to also allow genotypic correlation of antibiotic
resistance markers detected during the study. Based on the results
of the unblinded data set, testing of additional contrived samples
with well-characterized pathogen strains will complement and
provide additional data points for low prevalence strains and
antibiotic resistance markers. Based on all the data generated and
analyzed, OpGen will now start preparing a De Novo request package
for submission to the U.S. FDA in due course.
“Having completed the study as planned, we have
successfully generated a large and very comprehensive study data
set with multiple reference methods. We’d like to thank our study
sites for their contributions in generating these data.”, said
Johannes Bacher, Chief Operating Officer of OpGen. “Now that we
have unblinded the results, we are excited to proceed with our
in-depth analysis and compile the data submission to the FDA over
the next few months.”
"Urinary tract infections represent a major
healthcare burden, and diagnosing complicated UTI remains
challenging. Microbiological cultures take several days to provide
definitive results. Pathogenic microbial species may not be
detected due to prolonged exposure to antibiotics, and complex
polymicrobial infections may be difficult to
elucidate. The Unyvero UTI Panel is a new and promising
multiplex molecular test for the rapid detection of a comprehensive
range of pathogenic bacteria, fungi, and their associated
resistance markers directly from urine in under five
hours. Rapid results enable early diagnosis and effective
antibiotic therapy to help prevent serious complications in
UTI patients," said Dr. Christopher Emery, Associate Director of
Clinical Microbiology, Indiana University Health Pathology
Laboratory (IUHPL), Indianapolis, IN.
OpGen intends to present data from the study at
a future conference as well as to submit for a peer reviewed
publication.
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
preliminary analysis and top-line data from 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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