OpGen’s Acuitas® AMR Gene Panel Shows Potential for Reducing Total Time to Targeted Therapy
27 June 2019 - 9:30PM
OpGen, Inc. (Nasdaq: OPGN) today announced the presentation of data
obtained from the first multisite assessment evaluating the
potential clinical utility of its Acuitas® AMR Gene Panel using
clinical samples. The study tested 531 remnant urine specimens from
Beth Israel Deaconess Medical Center, Geisinger, and Intermountain
Healthcare with the Acuitas AMR Gene Panel (For Research Use Only
‘RUO’), to detect five pathogens and 47 antibiotic resistance genes
common to urinary tract infections (UTI). Results for the Acuitas
AMR Gene Panel (RUO) were produced in less than three hours.
These data were presented on June 22 by
Geisinger researchers at ASM Microbe 2019 in a poster titled
“Verification of Real Time PCR for the Detection of
Antibiotic-Resistance Markers and Semi-Quantitation of Urinary
Tract Pathogens from Urine Samples.”
For the two most prevalent microbial species, E.
coli and K. pneumoniae, the Acuitas Gene Panel had a total
agreement of 96% and 97%, respectively, for pathogen detection,
compared to MALDI-ToF mass spectrometry. Acuitas Lighthouse
predictions for phenotypic Antimicrobial Susceptibility Testing
(AST) showed 93% total agreement for E. coli and 92% total
agreement for K. pneumoniae, when compared to each site’s method
for phenotypic AST.
“Reducing the total time to targeted therapy,
especially in complicated UTIs that have an increased risk to
harbor antimicrobial resistance, has the potential to reduce
hospital length of stay and mortality rates among patients,” said
Dr. Donna Wolk, Division Director, Molecular and Microbial
Diagnostics, Geisinger.
The total agreement by antibiotic class for both
the E. coli and K. pneumoniae pathogens averaged 97% for
aminoglycosides, 92% for fluoroquinolones, and 93% for
cephalosporins. These data demonstrate that the Acuitas AMR Gene
Panel and Acuitas Lighthouse informatics may have the potential to
serve as a front-line diagnostic to reduce time to targeted therapy
for urinary tract infections (UTI), reducing length of stay and
mortality.
“We are pleased with the results of the
presented data, which further demonstrate the capabilities of our
Acuitas diagnostic test in development and Acuitas Lighthouse
Software as front-line tools in clinical settings to detect and
predict antibiotic resistance in urine specimens. We believe these
data further demonstrate the utility of our offering as a
diagnostic tool to help identify and manage complicated urinary
tract infections,” said Evan Jones, Chairman and CEO of OpGen.
UTIs are a significant cause of hospital
admissions and can be associated with mortality linked to
urosepsis. It is reported that 50-60% of all women will experience
a UTI in their lifetime, while 25% experience a second UTI within
six weeks of the first. Rapid and accurate detection has the
potential to reduce the time to targeted therapy for certain
UTI-causing pathogens, leading to a decrease in length of stay and
mortality.
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 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 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
OpGen (NASDAQ:OPGN)
Historical Stock Chart
From Jul 2024 to Aug 2024
OpGen (NASDAQ:OPGN)
Historical Stock Chart
From Aug 2023 to Aug 2024