District of Columbia Hospital Association Chooses OpGen to Create Citywide Effort to Track Multidrug-Resistant Bacteria

DC’s Public Health Agencies, Healthcare Facilities to Examine Occurrence of “Superbugs” in First-of-Its-Kind Evaluation, Supported by the Centers for Disease Control & Prevention

GAITHERSBURG, Md. and WASHINGTON, Nov. 18, 2015 (GLOBE NEWSWIRE) -- 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 MDROs
Multi-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 DCHA
Since 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.

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