Data Show “Super Bug” Surveillance System Based on OpGen’s Acuitas(R) Resistome Test Can Identify Potential Outbreaks i...
October 12 2015 - 8:30AM
OpGen, Inc. (NASDAQ:OPGN), an early-stage
commercial molecular testing and bioinformatics company, today
announced that new data from a study with its Acuitas® Resistome
Test were presented on October 10 as an oral abstract at IDWeek
2015 by Michael Lin, M.D., M.P.H., an infectious disease physician
and assistant professor of medicine at Rush University Medical
Center in Chicago. The conference was held October 7 to 11 in San
Diego. Dr. Lin and fellow researchers demonstrated how an Acuitas
Resistome-based surveillance system can identify potential
outbreaks to improve infection control, underscoring the need for
healthcare facilities to implement use of molecular-based
surveillance systems to detect potential outbreaks that may be
caused by multidrug-resistant organisms (MDROs). The research was
conducted under the support of the CDC Prevention Epicenters
Program and affiliated with the REALM project, a multi-hospital
voluntary surveillance network for monitoring multidrug-resistant
organisms among Chicago hospital intensive care units and long-term
acute care hospitals.
“Since KPC-producing Enterobacteriaceae can carry multiple
beta-lactamase genes, beta-lactamase resistome types can be markers
indicating how strains are related, and detect a potential
outbreak,” said Dr. Lin. “Resistant bacteria typically affect the
sickest patients, and accurate and early surveillance data is a key
part of our efforts in the Chicago area to successfully manage
infections and prevent outbreaks.”
In the study, investigators used OpGen’s test to analyze 363
KPC-producing Enterobacteriaceae culture isolates recovered from 77
distinct hospital-point prevalence rectal culture surveys in the
Chicago region from 2010 to 2014. The test discriminated two
dominant types in the region and elucidated the facility clustering
of minority types, suggesting its utility as an effective
infection-control tool.
“The research results from this study with the REALM project and
those from our other Acuitas MDRO Gene Test studies presented as
posters at IDWeek 2015 show how important it is for hospitals,
healthcare systems and public health agencies to develop ways to
quickly and accurately detect MDROs using comprehensive genetic
analysis and bioinformatics,” said Kevin Krenitsky, M.D., OpGen
President. “We are excited that our data demonstrate how the
Acuitas suite of products can fit into programs aimed at improving
the ability to rapidly identify MDRO threats, prevent outbreaks,
and reduce the incidence of antibiotic resistant infections. These
results provide important support to our sales team as we work to
cross sell these products into our existing QuickFISH™ customer
accounts.”
Details for all OpGen posters presented at the conference
follow:
Oral Abstract session: Epidemiology of Resistant Gram
Negative Infections. Poster 1378: Using the Acuitas
Resistome Test, Michael Lin, M.D., M.P.H. of Rush University
Medical Center in Chicago and colleagues studied 363 KPC-producing
Enterobacteriaceae from 77 point prevalence surveys as part of a
Centers for Disease Control & Prevention (CDC) program, and
found two dominant resistome types and resistome-type clusters that
illustrated the usefulness of developing resistome-based
surveillance to identify potential outbreaks.
Poster: Results from a Carbapenem-Resistant
Enterobacteriaceae (CRE) Point Prevalence Study Conducted at a
University Hospital. Poster Session 1783: Forest Arnold,
D.O., M.Sc. of the University of Louisville and colleagues tested
214 peri-anal swabs with the Acuitas MDRO Tests and discovered
three CRE identified by their resistant genes and two more non-CRE
but potentially carbapenem resistant organisms. Data suggested the
need for surveillance at admission and institution of contact
isolation to prevent spread of resistant bacteria among
hospitalized patients.
Poster: Fecal Carriage of Genes Associated with
Gram-Negative Multi-Drug Resistant Organisms. Poster
Session 1814: Sandra Richter, M.D. of the Cleveland Clinic and
colleagues tested 200 stool samples (16% positive for C. difficile)
with the Acuitas MDRO Gene Test. Colonization with OXA, VIM, KPC
and CTX-M genes were observed in 1%, 3%, 5% and 6% of inpatients,
respectively. Multidrug-resistant Gram-negative infections were
documented in the medical record at variable time intervals before
and/or after sample collection for 52% of patients colonized with
Gram-negative resistance genes.
About MDROsMultidrug-resistant organisms
(MDROs) are common bacteria that have developed resistance to
multiple classes of antibiotics. They are a leading cause of
hospital-acquired infections and are associated with an increase in
morbidity and mortality. Each year, more than two million Americans
acquire infections that are resistant to antibiotics and of those,
23,000 will die of those infections. Asymptomatic carriers are at a
higher risk of an MDRO infection and become reservoirs for
transmission to other patients in health care systems if not
accurately identified early. Since there are many types of
antibiotic resistant organisms, and the way they cause disease is
dictated by their genetics, knowing the exact genetic profile of
these organisms is a key step to preventing their ability to
infect.
About OpGenOpGen, Inc. is an early
commercial-stage molecular testing and bioinformatics company
focused on assisting healthcare providers to combat
multidrug-resistant organism (MDRO) bacterial infections –
“Superbugs.” The Company is addressing this growing public health
threat by rapidly delivering precise, actionable information to
help identify, combat, and prevent the spread of these complex
infections that jeopardize the safety of our hospitals and other
long-term care facilities. OpGen offers a full portfolio of
Acuitas® products including the MDRO Gene Test, the Resistome Test,
microbial Whole Genome Sequence Analysis, Acuitas Lighthouse™ MDRO
Management System and QuickFISH™, a suite of FDA-cleared and
CE-marked diagnostics for rapid molecular testing of positive blood
cultures designed to assure appropriate antibiotic therapy.
Learn more at www.opgen.com
OpGen Forward-Looking Statements This
press release includes statements relating to the company's
products and services. These statements and other statements
regarding our 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 rate of adoption of
our products and services by hospitals, the success of our
commercialization efforts, the effect on our business of existing
and new regulatory requirements, and other economic and competitive
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cautioned not to place undue reliance on these forward-looking
statements, which are based on our expectations as of the date of
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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.
Contacts:
OpGen
Michael Farmer
Director, Marketing
(240) 813-1284
mfarmer@opgen.com
InvestorRelations@opgen.com
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