OpGen Presents Preliminary Acuitas® AMR Gene Panel Data for Detecting Urinary Tract Infections
07 October 2019 - 10:30PM
OpGen, Inc. (Nasdaq: OPGN) today announced the presentation of
preliminary data at IDWeek 2019 for the Company’s Acuitas® AMR Gene
Panel and Acuitas Lighthouse® Software for the detection of
urinary tract infections (UTI). The data demonstrate the
concordance of Acuitas AMR Gene Panel results with conventional
urine culture and the agreement with whole genome sequencing for
the detection of a broad set of resistance genes that span nine
antibiotic classes. Data showing antibiotic resistance predictive
alignment with antibiotic susceptibility testing were also
presented at the meeting.
The data were presented on October 5 by OpGen’s
Director of Clinical Laboratory, Jamie Lemon, Ph.D., D(ABMM) during
the session “Rapid Diagnostics and Resistance: Making Sense of Now
and the Future Part 2.”
The presented data revealed that, in a study
that analyzed over 580 remnant urine specimens, OpGen’s rapid,
semi-quantitative Acuitas AMR Gene Panel (For Research Use Only
‘RUO’) was 93% concordant with conventional urine culture results,
using a clinically significant threshold. Furthermore, new data
presented from a multicenter clinical trial for isolate testing
found that, when compared to whole genome sequencing, the
Acuitas AMR Gene Panel (For Investigational Use Only ‘IUO’) had an
average positive agreement greater than 96% and a negative
agreement of greater than 99% for resistance gene detection. Over
1,000 isolates were tested in this study.
“We are pleased with the results of these recent
studies, as we continue the verification and validation work for
our Acuitas AMR Gene Panel for UTIs and Acuitas Lighthouse
Software. They offer great potential as frontline tools for
rapidly detecting UTIs and predicting antibiotic resistance,” said
Dr. Lemon. “Semi-quantitative detection of pathogens directly from
urine in less than three hours, in addition to accurate resistance
gene detection and antibiotic resistance predictions, will be
important for UTI management and minimizing the growing risk of
antibiotic resistance. We are thrilled to share the progress we’ve
made with fellow clinical experts at IDWeek 2019.”
The Acuitas AMR Gene Panel is a molecular
test, designed to detect five pathogens and up to 47
antibiotic-resistance genes in less than three hours. The
test, from OpGen, is currently available for research use only
(RUO) and is not for use in diagnostic procedures. Earlier
this year, clinical trials were conducted for establishing the
performance of the Acuitas AMR Gene Panel for use with bacterial
isolates. Data obtained from the clinical trials were submitted in
a 510(k) submission to the U.S. Food and Drug Administration (FDA).
OpGen is conducting clinical trials in 2019 to support a
submission for its direct-from-urine Acuitas AMR Gene
Panel test and the Acuitas Lighthouse Software for antibiotic
resistance prediction direct from clinical samples and the
management of antimicrobial resistance data in healthcare
institutions.
About OpGen
OpGen, Inc. is a precision medicine company
harnessing the power of molecular diagnostics and informatics to
help combat infectious disease. We are developing molecular
information products and services for global healthcare settings,
helping to guide clinicians with more rapid and actionable
information about life threatening infections, improve patient
outcomes, and decrease the spread of infections caused by
multidrug-resistant microorganisms, or MDROs.
Our molecular diagnostics and informatics
products, product candidates and services combine our Acuitas
molecular diagnostics and Acuitas Lighthouse informatics
platform for use with our proprietary, curated MDRO knowledgebase.
We are working to deliver our products and services, some in
development, to a global network of customers and
partners. The Acuitas AMR Gene Panel (RUO) is intended
for Research Use Only and is not for use in diagnostic procedures.
The Acuitas Lighthouse Software is not distributed commercially for
antibiotic resistance prediction and is not for use in diagnostic
procedures. For more information, please
visit www.opgen.com.
OpGen, Acuitas, and Acuitas
Lighthouse are registered trademarks of OpGen, Inc.
Forward-Looking Statements
This press release includes statements relating
to study results related to OpGen’s Acuitas AMR Gene Panel and
Acuitas Lighthouse Software products in development. 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 success of our commercialization efforts,
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 Contact: Michael Farmer Vice President,
Marketing (240)
813-1284mfarmer@opgen.comInvestorRelations@opgen.com
Press Contact:Matthew BretziusFischTank
Marketing and PRmatt@fischtankpr.com
Investor Contacts:Joe Green Edison
Group jgreen@edisongroup.com
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