OpGen Products in Development to Address “Urgent Threat” Pathogens Highlighted in New CDC Report on Antibiotic Resistance...
November 19 2019 - 7:30AM
OpGen, Inc. (Nasdaq: OPGN) announced today that the Center for
Disease Control (CDC) has released updated data increasing the
number of deaths in the United States (U.S.) from
antibiotic-resistant bacteria and fungi, and highlighting the
continuing threat of rising antibiotic resistance. According to the
CDC, these pathogens cause more than 2.8 million infections and
35,000 deaths in the U.S. each year. That means, on average,
someone in the United States gets an antibiotic-resistant infection
every 11 seconds, and every 15 minutes, someone dies1.
OpGen’s products have been developed to help combat these growing
threats. The Acuitas® AMR Gene Panel test, currently in
development, is designed to help identify drug-resistant pathogens
directly from urine as an aid in the diagnosis of urinary tract
infections in under three hours. The Acuitas® Lighthouse Software,
also in development, is currently being tested in a state-wide
initiative to help quickly identify and track urgent threat
pathogens.
Evan Jones, Chairman and CEO of OpGen,
commented, “We applaud the CDC for continuing to focus on the
growing challenge of antimicrobial resistant (AMR) pathogens. This
new report highlights that there were nearly twice as many annual
deaths as the CDC originally reported in 2013, which is why we are
encouraged that our Acuitas® products can help address these rising
threats.”
The Acuitas® AMR Gene Panel (Urine) test is
being developed for patients at risk for complicated urinary tract
infections (cUTI) and is designed to test for up to five pathogens
and up to 47 antimicrobial (AMR) genes. When paired with the
Acuitas® Lighthouse Software, OpGen believes the test will be able
to help improve management of the more than one million patients in
the United States with cUTI. Specifically, the Acuitas® AMR Gene
Panel (Urine) test, in combination with the Acuitas® Lighthouse
Software, both in development, can help test for and identify major
concerns for hospital patients, including Carbapenem-Resistant
Enterobacteriaceae (CRE), Multidrug-Resistant (MDR) Pseudomonas
Aeruginosa, and Extended-Spectrum Beta-Lactamase (ESBL) Producing
Enterobacteriaceae.
OpGen is conducting clinical trials in 2019 to
support a submission for the direct-from-urine Acuitas AMR Gene
Panel (Urine) test and for the Acuitas Lighthouse Software for
antibiotic resistance prediction for the management of
antimicrobial resistance data in healthcare institutions. 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 which is currently under review by the U.S.
Food and Drug Administration (FDA).
About Carbapenem-Resistant
Enterobacteriaceae (CRE), Multidrug-Resistant (MDR) Pseudomonas
Aeruginosa
CRE are a major concern for patients in
healthcare facilities. Some bacteria in this family are resistant
to nearly all antibiotics, leaving more toxic or less effective
treatment options. The 13,000 cases in hospitalized patients in the
US in 20171 demonstrate the need for tests such as the Acuitas® AMR
Gene Panel (Isolates) and tools such as the Acuitas® Lighthouse
software for the management of antimicrobial resistance data.
Pseudomonas Aeruginosa causes many types of healthcare associated
infections, including pneumonia, bloodstream infections, urinary
tract infections, and surgical site infections. The 32,600
estimated cases in hospitalized patients in 2017 resulted in 2,700
estimated deaths.
About Extended-Spectrum Beta-Lactamase
(ESBL) Producing Enterobacteriaceae
ESBL-producing Enterobacteriaceae (a family of
different types of bacteria) are a concern in healthcare settings
and the community. They can spread rapidly and cause or complicate
infections in healthy people. Annual cases have increased 33% since
2012 to 197,400 with 9,100 deaths1. ESBL E. Coli have been
increasing rapidly in cUTI patients highlighting the growing need
for rapid, accurate detection and decision-making technology.
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 updated CDC data highlighting the continued threat of rising
antibiotic resistance and OpGen’s products in development to help
address such threat. 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,
advance our current and planned 510(k) clearance submissions with
the FDA, and continue our activities under the New York State
Infectious Disease Digital Health Initiative. 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 (SEC). 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.
1 CDC. Antibiotic Resistance Threats in the United States, 2019.
Atlanta, GA: U.S. Department of Health and Human Services, CDC;
2019.
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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