OpGen Submits De Novo request to the U.S. FDA for Unyvero Urinary Tract Infection Panel
April 18 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, today announced
that it has submitted a De Novo classification request to the U.S.
Food and Drug Administration (FDA) seeking marketing authorization
for its Unyvero UTI Urinary Tract Infection (UTI) panel, following
successful completion of its 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 against various reference tests, using clean-catch or
catheter related urine samples. Across all prospectively enrolled
samples, the primary study endpoint was successfully met by
demonstrating an overall weighted average sensitivity of 96.8% and
overall weighted average specificity of 97.4% when compared against
each trial site’s standard of care microbiology results. Since
completion of enrollment, OpGen has performed testing of contrived
samples with well characterized strains to provide additional data
for low-prevalence strains and antibiotic resistance markers at its
facility in Germany and generated next-generation sequencing (NGS)
data at its Rockville, Maryland, lab facility to establish
genotypic correlation of antibiotic resistance markers detected
during the study.
“Following the in-depth analysis of all of our
clinical trial data, we have compiled a comprehensive submission
package for our De Novo classification request, building on a large
data set of Unyvero data and multiple reference methods,” explained
Johannes Bacher, Chief Operating Officer of OpGen. “This marks a
major milestone, and we’re looking forward to working closely with
the FDA during the interactive review for the Unyvero UTI panel,
which we hope to become the first high multiplex molecular
diagnostic IVD for urine samples granted by the FDA.”
OpGen will present data from the study at the
ASM Microbe 2023 conference in Houston, TX, on June 17, 2023, and
together with the principal investigators also intends 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, 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 submission of a U.S. FDA De Novo classification request for
its 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,
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
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, our ability to realize
any anticipated benefits from the reverse stock split, including
maintaining its listing on the Nasdaq Capital Market and attracting
new investors, 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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