OpGen, Inc. (NASDAQ:OPGN) and the District of Columbia Hospital
Association (DCHA) today announced that Washington DC’s public
health departments will oversee a comprehensive citywide
evaluation, HARP-DC (Healthcare facility Antibiotic Resistance
Prevalence-District of Columbia), to gauge the prevalence of the
multidrug-resistant Gram-negative bacteria Carbapenem-resistant
Enterobacteriaceae (CRE) in healthcare facilities throughout the
District of Columbia. The DC Department of Health (DOH)-led study
is being funded by the Centers for Disease Control and Prevention’s
(CDC’s) Epidemiology and Laboratory Capacity for Infectious
Diseases (ELC) Funding program for tracking healthcare-associated
infections (HAI). The Department, in turn, has contracted OpGen to
perform related laboratory services. The DC Department of Forensic
Sciences-Public Health Laboratory (DFS-PHL) is also participating
in the study by providing logistical support and by sequencing and
banking isolates recovered from cultures.
The HARP-DC study marks the first effort of this kind in the
District to proactively combat CRE, heeding the CDC’s call by
banding together a city’s healthcare providers, public health
departments and industry representatives using a highly
collaborative and forward-thinking, innovative approach with
advanced molecular technology.
CRE is in a family of bacteria that are normally found in the
stomach (or “gut”). This so-called “superbug” is easily
transmissible and often resistant to even “last resort”
antibiotics. According to a global meta-analysis (Falagas et al.
2013), between 40 to 80 percent of people who develop these
potentially untreatable infections will die. Recent outbreaks of
CRE have presented challenges for prominent hospitals nationwide,
prompting attention from the CDC and other public health
agencies.
“We issued a call-to-action in a recent report, asking for state
and local health departments to safeguard against the spread of
multidrug-resistant infections by working with local healthcare
facilities. One way to improve the local understanding of
resistance is to assess the number of patients with specific drug
resistant infections,” said Denise Cardo, M.D., Director of CDC’s
Division of Healthcare Quality Promotion. “The HARP-DC study is an
example of a public-private partnership that can improve our
knowledge about resistant infections in the nation’s capital
through the combined efforts of the city’s health departments, the
DCHA, and OpGen.” With coordination by DCHA, healthcare facilities
in the District – including acute care, long-term care and skilled
nursing facilities – will participate in the study to better
understand the rates of CRE colonization and infection. DCHA member
hospitals participating in this study include: BridgePoint Hospital
– both Capitol Hill & Hadley campuses, Children's National
Medical Center, George Washington University Hospital, Howard
University Hospital, Providence Hospital, MedStar Georgetown
University Hospital, MedStar Washington Hospital Center, Sibley
Memorial Hospital and United Medical Center.
“We know that individuals in our local healthcare facilities are
harboring CRE and are unknowingly at risk. At this point, while CRE
is still a rare event, it can spread outside the gut quickly,
particularly in people who are taking antibiotics for other
ailments or whose health is in a comprised or weakened state,” said
Robert Malson, DCHA President. “With cooperation from many of our
member facilities, our goal with this study is to gain a better
understanding about the prevalence of CRE in Washington
metropolitan hospitals and skilled nursing facilities. With
information in hand, we can proactively implement additional safety
measures to prevent transmissions and help ensure the health of our
patients.”
Glenn Wortmann, M.D., Chief, Infectious Diseases Section,
MedStar Washington Hospital Center, said, “We are very pleased to
be participating in this important evaluation. Collaboration of
this kind will help us gain much greater insights into CRE and,
ultimately, we will be better prepared to prevent it in the future
– ensuring the safety of our patients.”
OpGen is providing multidrug-resistant organism (MDRO) testing
support through its clinical laboratory using its suite of Acuitas®
MDRO Tests and Acuitas Lighthouse™ MDRO Management System for
bioinformatics analysis. Over the next several weeks, each facility
participating in the study will test patients for three days across
designated units to proactively determine the CRE threat in these
facilities. This will identify the patient care units that are at
the highest risk and allow for heightened infection control
measures in those facilities to minimize transmissions and prevent
outbreaks. The DFS-PHL and DOH will gain real-time surveillance
data for the superbug during the study.
“The OpGen team is proud to support this effort with our
technology and expertise as a means to help curb this emerging and
life-threatening bacteria in our own metropolitan area,” said Evan
Jones, Chairman and CEO of OpGen. “MDROs, including CRE, threaten
the welfare of patients and the quality of healthcare provided, as
well as create a significant cost burden to healthcare
facilities.”
In early August, the CDC issued a Vital Signs report entitled
“Making Health Care Safer” in which the authors identified “a
tipping point,” explaining that an increasing number of germs no
longer respond to the drugs designed to kill them and that
inappropriate prescribing of antibiotics and lack of infection
control actions can contribute to drug resistance and put patients
at risk.
About MDROsMulti-drug resistant organisms
(MDROs) are common bacteria that have developed resistance to
multiple classes of antibiotics. They are a leading cause of
healthcare-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.
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 DCHASince its inception in 1978, the
District of Columbia Hospital Association (DCHA) has advocated on
behalf of the District’s hospitals to ensure they are able to
thrive and provide residents and visitors of the District of
Columbia with the world-class care they deserve. DCHA partners with
agencies and legislators to develop policies that have a positive
impact on District patients in our hospitals. With the continued
changes in health care nationally, DCHA’s member hospitals
collaborate with each other and key stakeholders across the
District to raise quality and safety for all patients and their
workforces. DCHA member hospitals will achieve this goal through a
commitment to innovation, collaboration and a focus on
District-specific issues and challenges. Learn more at
www.dcha.org.
About OpGen
OpGen, 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
Evan Jones, the CEO and Chair of the Board of OpGen, is a
trustee of the Children's National Medical Center, one of the
participating hospitals.
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
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 (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.
Contacts:
OpGen Corporate
Michael Farmer
Director, Marketing
(240) 813-1284
mfarmer@opgen.com
InvestorRelations@opgen.com
OpGen Investors
LHA
Kim Sutton Golodetz
(212) 838-3777
kgolodetz@lhai.com
or
Bruce Voss
(310) 691-7100
bvoss@lhai.com
OpGen Media
Lisa Guiterman
(301) 217-9353
lisa.guiterman@gmail.com
DCHA
Dr. Jo Anne Nelson
Executive Vice President
(202) 682-1581
jnelson@dcha.org
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