OpGen Announces New Data Demonstrating Clinical Utility for Antibiotic Resistant Urinary Tract Infection Patient Management a...
June 13 2019 - 7:30AM
OpGen, Inc. (Nasdaq: OPGN) announced today that data from its
Acuitas® AMR Gene Panel and Acuitas Lighthouse® Software will
be presented at ASM Microbe 2019 being held June 20-24 in San
Francisco, California at the Moscone Convention Center. The
presentation will include a comparative analysis of Acuitas
Lighthouse and Whole Genome Sequencing (WGS) for
Carbapenemase-producing organisms (CPO) in an outbreak
investigation conducted by the New York State Department of
Health’s Wadsworth Center. The Acuitas Lighthouse data will
be shown concordant to WGS but with a faster turnaround time
suggesting that Acuitas AMR Gene Panel and Acuitas Lighthouse can
be used as front-line tools in clinical settings for transmission
and outbreak detection. In addition to general conference
acceptance, these data were selected to be featured in a podium
presentation.
Also at the meeting, data from a clinical
verification study for the Acuitas AMR Gene Panel test for urine
will be presented by Geisinger. In this study, over 500 of
the remnant urine specimens collected and tested at Beth Israel
Deaconess Medical Center (BIDMC), Geisinger, and Intermountain
Healthcare were analyzed. The data demonstrate that the
Acuitas AMR Gene Panel had greater than 90% agreement with
quantitative culture for semi-quantitative pathogen detection and
Acuitas Lighthouse phenotype predictions had greater than 90%
average total agreement with antibiotic susceptibility testing for
E. coli and K. pneumoniae, the most common pathogens that cause
urinary tract infections (UTI).
Other data featured at the conference will be
presented by Intermountain Healthcare. These data are from a
collaborative study with BIDMC and OpGen demonstrating the
potential of Acuitas AMR Gene Panel and Acuitas Lighthouse to be
used as a rapid diagnostic to guide early, empiric antibiotic use
in patients with UTI from antibiotic resistant bacteria.
Lastly, OpGen will present its research into genetic mechanisms
that increase the risk of antimicrobial resistance in bacteria.
The Acuitas AMR Gene Panel is a new
molecular test being developed by OpGen, designed to detect
five pathogens and 47 antibiotic-resistance genes in less than
three hours. The test 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.
The ASM Microbe 2019 presentation schedule for
OpGen’s data is as follows:
Poster title: |
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A Comparative Analysis of Highly-Multiplexed Real Time PCR
and Whole Genome Sequence Analysis for Outbreak
Investigation |
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Presenter: |
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E. Snavely (Wadsworth Center, New York State Department of
Health) |
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Date and time: |
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Friday, June 21, 10:30 a.m. – 5:00 p.m. PTSunday, June 23, 3:10
p.m. – 3:20 p.m. PT |
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Location: |
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Poster and Exhibit Halls A-E, CPHM Track, Friday Po. 899
(Friday)CPHM Lounge and Learn – South – Level 2 (Sunday) |
Poster Title: |
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Culture Independent, Molecular Detection of Uropathogens
and Antibiotic Resistance Genes Direct from Urine
Specimens |
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Presenter: |
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B. Lopansri (Intermountain Healthcare) |
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Date and time: |
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Friday, June 21, 10:30 a.m. – 5:00 p.m. PT |
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Location: |
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Exhibit Halls A-E, CPHM Track, Friday Po. 845 |
Poster Title: |
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Verification of a Real Time PCR for the Detection of
Antibiotic-Resistance Markers and Semi-Quantitation of Urinary
Tract Pathogens from Urine Samples |
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Presenter: |
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A. Styer (Geisinger) |
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Date and time: |
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Saturday, June 22, 10:30 a.m. – 5:00 p.m. PT |
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Location: |
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Poster and Exhibit Halls A-E, CPHM Track, Saturday Po.
970 |
Poster title: |
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Impaired DNA Mismatch Repair System Increases the Risk of
Emerging Antibiotic Resistance in Bacteria |
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Presenter: |
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W. Chang (OpGen) |
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Date and time: |
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Saturday, June 22, 10:30 a.m. – 5:00 p.m. PT |
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Location: |
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Poster and Exhibit Halls A-E, AAR Track, Saturday Po. 620 |
Poster presentations will be held daily from
11:00 a.m.-12:00 p.m. and 4:00 p.m.-5:00 p.m. PT. To learn more
about these presentations or to schedule a meeting with a member of
the OpGen team, please contact mfarmer@opgen.com.
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 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 Contact:Joe Green Edison Group
jgreen@edisongroup.com
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