OpGen Initiates Clinical Trial for Unyvero Urinary Tract Infection Panel
September 30 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, announced today that it has
initiated the clinical trial for its Unyvero Urinary Tract
Infection (UTI) Panel, which allows testing for a broad range of
pathogens as well as antimicrobial resistance markers directly from
native urine specimens.
The Unyvero System and Unyvero Lower Respiratory
Tract panels have already been cleared by the U.S. Food and Drug
Administration. The sample-to-answer Unyvero System uses highly
multiplexed PCR technology. The Unyvero UTI panel is a new
application, and the overall trial design is very similar to
previous studies and aims to demonstrate the product’s clinical
performance. Following FDA guidance, the trial is expected to
enroll more than 1,500 prospective patient samples, to be
complemented with archived, microbiology positive specimens.
Primary endpoint of the study will be assay performance as defined
by clinical sensitivity and specificity compared to culture-based
standard of care microbiology. The study will be conducted at
multiple sites in the U.S. Unyvero instrument setup and site
initiation visits are ongoing following the trial sites’
Institutional Review Board (IRB) approval of the study protocol,
which is designed to meet FDA requirements. Study execution will be
supported by all OpGen group companies as well as external third
party CRO and laboratory service providers. It is anticipated that
the data from this study will be used to support the subsequent
submission to the FDA for clearance in the U.S.
“UTIs are among the most common infectious
diseases, and they can be devastating. With an estimated 3 million
cases each year in the U.S., complicated UTIs are a leading cause
of infection-related hospitalization and are associated with higher
morbidity and mortality,” commented Faranak Atrzadeh, OpGen’s Chief
Marketing and Scientific Affairs Officer. “Effective treatment of a
cUTI depends on the rapid and accurate identification of the
pathogen(s) and the correct choice of antibiotic(s). The clinical
utility of culture-based laboratory testing is fraught with
limitations including subjectivity, specificity, delayed time to
results, and missed positive samples, especially in patients
hospitalized with urosepsis who often tend to have complex
infections with multiple organisms present. We believe that the
Unyvero UTI panel would be a valuable diagnostic tool to help treat
these patient populations.”
Johannes Bacher, OpGen’s Chief Operating Officer
added, “We are excited to move this major clinical trial towards
FDA clearance of our next Unyvero product off the ground. Given the
two FDA cleared Unyvero LRT panels addressing patients with
suspected pneumonia already, this is a key expansion of the breadth
and utility of the Unyvero platform in the U.S. market. It is
further complemented by our Acuitas AMR Gene Panel for Isolates.
Once again with Unyvero UTI we strive to bring a very broad panel
of critical pathogens paired with a very broad panel of genetic AMR
markers to patients and their doctors.”
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
a clinical trial for OpGen’s Unyvero Urinary Tract Infection (UTI)
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, 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 our 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:Oliver SchachtPresident and
CEOInvestorRelations@opgen.com
OpGen Press Contact:Matthew
Bretzius FischTank Marketing and PR matt@fischtankpr.com
OpGen Investor Contact:Joe Green Edison
Group jgreen@edisongroup.com
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