OpGen Presents Unyvero Urinary Tract Infection Panel Trial Results at ASM Microbe 2023 Conference
June 20 2023 - 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 that its
Principal Scientist Dr. Matthias Klein has presented results from
the clinical trial for its Unyvero Urinary Tract Infection Panel
during ASM Microbe’s In Depth Symposium session ‘The Year in
Clinical Microbiology’ on June 17th in Houston, TX. Based on over
1,800 patient samples, the presentation titled “Multi-Center
Clinical Trial Using a Novel Semi-Quantitative Multiplex-PCR Based
Diagnostic Panel for Urinary Tract Specimens” summarized the
objectives of the clinical trial, the Unyvero UTI panel coverage
and result evaluation recommendations based on multiple reference
testing methods applied during the study.
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 company’s De Novo
classification request to the U.S. Food and Drug Administration
(FDA) was submitted in April 2023 and is currently under
Substantive Review by the FDA. OpGen is seeking marketing
authorization for its Unyvero UTI panel.
“As discussed during my presentation, analysis
and evaluation of such a large clinical trial data set was a
challenge, given the complexity of result quantitation, multiple
reference methods and the frequent presence of flora in urine
samples,” explained Dr. Klein. “Our data demonstrated that the
Unyvero UTI panel covered nearly 94% of all organisms identified in
standard of care microbiology culture. It helped identify a
significant number of additional organisms in the study that were
missed or not reported by standard of care testing alone, with an
overall weighted average sensitivity of 96.9% and an overall
weighted average specificity of 97.1%.”
“We have developed and presented recommendations
for the evaluation of UTI results and demonstrated Unyvero UTI’s
good correlation to local lab culture results. 95.9% of single
organisms identified by culture were correctly included in the
corresponding Unyvero result, with 74.7% being completely
concordant. Given that recurrent UTI infections often are treated
with antibiotics, which can compromise microbiology results, we are
excited that the Unyvero UTI panel is offering rapid and
comprehensive molecular detection. We will continue our in-depth
analysis and intend to submit further results for a peer reviewed
publication together with the study’s principal investigators.”
In another poster presentation titled “Multiplex
Molecular Panel as a Supplement to Routine Culture for Tissue
Infection,” the authors Cox et al. at the University of Cincinnati
concluded that “multiplex PCR panel may play an important role in
supplementing routine laboratory testing and improving the
diagnostic yield for tissue infections for culture-negative
results.” This was based on a study of 47 tissue homogenate samples
tested with Unyvero Implant and Tissue Infection (ITI) cartridges
in a research use only setting. In that study, Unyvero ITI
performed at a sensitivity of 81.5% compared to culture which
showed a sensitivity of 72.2%.
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 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, ARESasp, 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 De Novo classification request to the FDA for its Unyvero
Urinary Tract Infection UTI panel and its recent presentations at
ASM Microbe conference. 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, 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 Investor & Press Contact:Alyssa
FactorEdison Groupafactor@edisongroup.com
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