New Study Data Show OpGen’s QuickFISH® Blood Culture Pathogen ID Tests to be Rapid and Cost-Effective, with Utility to Inform Antimicrobial Stewardship Decisions

GAITHERSBURG, Md., April 11, 2016 -- OpGen, Inc. (NASDAQ:OPGN), a precision medicine company using molecular diagnostics and bioinformatics to combat infectious disease, today announced that new study data on its QuickFISH^® tests were presented at the 26^th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) being held from April 9^th to 12^th in Amsterdam.

The studies were conducted at the NHS Royal Free Trust Hospital in London and were presented in two posters on Saturday, April 9^th.

Abstract #2455. Rapid differentiation of Staphylococcus aureus from coagulase-negative staphylococci directly from positive blood cultures: prospective comparison of four rapid methods; Rebecca Gorton, et al.  

Abstract #6601. The potential utility of QuickFISH on positive blood cultures to inform antimicrobial stewardship decisions; Tehmina Bharucha, et al.

In the first poster, investigators concluded that QuickFISH rapidly differentiated Staphylococcus aureus from coagulase-negative staphylococci directly from blood cultures. It was the fastest and most cost-effective nucleic acid method evaluated with a time-to-result of 20 minutes, and had a higher diagnostic concordance to routine methods than MALDI-TOF. Other methods evaluated included Cepheid GeneXpert^® and a tube coagulase test.

In the second poster, the investigators reported that communicating Gram stain and QuickFISH results together with clinical context (including local resistance patterns) can help inform physicians in early patient management decisions.  They concluded that the development of a treatment algorithm based on the results may enhance the clinical benefits of QuickFISH.  

Also at the conference, OpGen previewed the QuickFISH Digital Imager, which will automate the QuickFISH procedure and digitize the results.  The bench-top instrument is currently in development and is being designed to eliminate the requirement of a fluorescence microscope and darkroom.  Development plans include the integration of the Digital Imager with Acuitas Lighthouse™, its bioinformatics platform that will allow rapid analysis of pathogen identity in the context of an antibiotic resistance database, providing decision support for patient management.

“We are encouraged by the impact we are making with premier healthcare institutions such as the NHS Royal Free Trust Hospital with our current QuickFISH products, and are equally excited about our future and the progress we are making with our development programs,” commented Kevin Krenitsky, M.D., OpGen’s president.  “We are working to transform the way infectious diseases and antibiotic resistance are managed through the use of molecular and digital technologies. Our aim is to apply the principles of precision medicine to improve patient outcomes, reduce hospital costs and preserve the supply of effective antibiotics.”

About QuickFISH

QuickFISH provides rapid and accurate identification of critical bloodstream infections 1-3 days earlier than conventional identification methods. Conventional methods employ sub-culturing, overnight incubation and phenotypic identification that can take days.  With QuickFISH, results are available within 30 minutes from the positive blood culture.

About ECCMID

ECCMID is the annual congress of the European Society of Clinical Microbiology and Infectious Disease. Since its founding in 1983, ESCMID has evolved to become Europe’s leading society in clinical microbiology and infectious diseases with members from all European countries and all continents.  ESCMID is registered in Switzerland with offices in Basel.

About OpGen

OpGen, Inc. is developing and deploying precision medicine tools to combat infectious disease in global healthcare settings, helping clinicians improve patient outcomes by providing more rapid information about life-threatening infections and decreasing the spread of infections caused by multidrug-resistant microorganisms.  OpGen offers a full portfolio of in vitro diagnostic products and clinical laboratory services that employ state-of-the-art molecular diagnostics and bioinformatics.  Its QuickFISH® products are a suite of FDA-cleared and CE-marked diagnostics used to rapidly detect pathogens in positive blood cultures.  Clinical laboratory services utilize the Acuitas® products, including the MDRO Gene Test, the Resistome Test, microbial Whole Genome Sequence Analysis, and Acuitas Lighthouse™ bioinformatics platform designed to detect, type, track and trend antibiotic resistant organisms in real-time.  Learn more at www.opgen.com and follow OpGen on Twitter and LinkedIn.  

Forward-Looking Statements 

This press release includes statements relating to the company's QuickFISH products, and commercialization plans for its 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 and other health care providers, 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
Michael Farmer
Director, Marketing
(240) 813-1284
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Investors
LHA
Kim Sutton Golodetz
(212) 838-3777
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or
Bruce Voss
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