OpGen Releases Next-Generation Molecular Testing and Bioinformatics Solution for Combating Multi-Drug Resistant Infections

06.02.15

- Company Participating in Today's White House Forum on Antibiotic Stewardship
- Acuitas® Resistome, Acuitas Whole Genome Sequencing, and Acuitas Lighthouse MDRO Management System Now Available

GAITHERSBURG, Md., June 2, 2015 (GLOBE NEWSWIRE) --  OpGen, Inc. (Nasdaq:OPGN), an early commercial-stage molecular testing and bioinformatics company, today launched its expanded, comprehensive molecular testing and bioinformatics program for detecting and managing Gram negative multi-drug resistant organisms, or MDROs. These products and services are designed to enable healthcare providers to rapidly identify and help manage hospital patients who are colonized or infected with life-threatening, drug resistant organisms.

OpGen also announced that it has been selected to participate in the White House Forum on Antibiotic Stewardship, being held today in Washington, D.C. The event brings together key federal and private-sector constituencies involved in the development, promotion and implementation of antibiotic stewardship activities to ensure the responsible use of antibiotics nationwide. A live stream of the opening session will be available beginning at 8:00 a.m. Eastern time via www.whitehouse.gov/live.

"The prevalence of multi-drug resistant organisms is an enormous public health problem, the treatment of which has been hampered by a limited supply of effective antibiotics and lack of advanced diagnostic tests for MDROs, or 'superbugs.' OpGen is proud to participate in active dialogue on the issue of MDROs during today's White House Forum," said Evan Jones, Chairman and CEO of OpGen. "We are excited about the opportunity to introduce to the forum our latest tests and bioinformatics systems, which we believe are among the most sensitive and highest-resolution methods for detecting and analyzing MDROs."

The company's first commitment to this forum is to complete development, validation and commercialization of its Acuitas suite of MDRO Tests and the Acuitas Lighthouse MDRO Management System. To that end, OpGen launched these new products at the American Society for Microbiology's 2015 meeting (ASM 2015) and presented data at a symposium it hosted, entitled "Standing Up to Superbugs." The product launches demonstrate OpGen's ability to quickly develop high-resolution tools for hospitals. These products and services aid in combating antibiotic resistance, improving patient outcomes and reducing healthcare costs.

The new Acuitas Resistome Test is designed to detect approximately 50 antibiotic resistance genes in Gram-negative bacteria. Acuitas Whole Genome Sequence Analysis provides high-resolution strain typing and sub typing of a full spectrum of resistance genes. Both tests analyze clinical bacterial isolates and complement the company's Acuitas MDRO Gene and CR Elite screening tests. The Acuitas Lighthouse MDRO Management System provides detailed MDRO molecular information about an individual patient's resistance profile, gleaned from our Acuitas MDRO Gene Test results, and integrates this data with other patient and hospital-wide data to help improve overall patient outcomes and to reduce hospital costs. With today's launch, the Acuitas Lighthouse system is available for integrating laboratory test results. We anticipate the full web-based system will be launched commercially in the third quarter of 2015. These new products and services are available from OpGen's CLIA testing laboratory. They also help advance the White House's five-year agenda to develop advanced diagnostics of drug-resistant infections, and to collaborate to improve antibiotic prescribing practices and prevent resistant bacteria from spreading.

"Multi-drug resistant Enterobacteriaceae are multiplying globally, especially CREs and ESBLs associated with the CTX-M-15 gene. Hospitals should develop active surveillance programs based on their risks of multi-drug resistant Gram-negative organisms. It is important to first understand what those risks are, especially in the communities the hospital serves," said Lance R. Peterson, M.D., NorthShore Medical Group, an infectious disease expert on the front line of preventing and managing antibiotic-resistant infections. Dr. Peterson served as a presenter during the OpGen symposium at ASM 2015.

Every year in the U.S., about 23,000 people die from antibiotic-resistant infections, and the cost of treating these infections is estimated to be between $20 billion to $35 billion. To further help address this problem, the additional pillars of OpGen's commitment to the forum include working to enable rapid diagnostics and optimal antibiotic stewardship, publishing rigorous clinical outcome and economic benefit studies with its partner healthcare systems, helping to coordinate a surveillance network, collaborating with the CDC Foundation on studies that seek to quantify the incidence of antibiotic resistant bacteria in both infected patients and asymptomatic carriers, and working with advocacy organizations to help educate healthcare administrators and other healthcare providers about infection-reduction techniques.

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 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. 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 OpGen

OpGen, Inc. is an early commercial stage company using molecular testing and bioinformatics to assist healthcare providers in combating multi-drug resistant bacterial infections. The company's products and services are designed to enable the rapid identification of hospital patients who are colonized or infected with life-threatening, multi-drug resistant organisms, or MDROs. The company's products include the Acuitas MDRO Gene Test, the Acuitas Resistome and Whole Genome Sequencing Tests and the Acuitas Lighthouse MDRO Management System. In addition, the company has more than 10 years of experience mapping microbial, plant and human genomes. Learn more at www.opgen.com.

Forward-Looking Statements

This press release includes statements relating to the company's Acuitas MDRO Gene Test and Acuitas Lighthouse MDRO Management System and commercialization plans for these 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.

CONTACT: OpGenMichael Farmer
         Director, Marketing
         (240) 813-1284
         mfarmer@opgen.com
         InvestorRelations@opgen.com

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OpGen, Inc.