OpGen Subsidiary Curetis GmbH and Karolinska Institutet Collaborate in Study of Bacterial Co-Infections in COVID-19 Pneumonia Patients

- Investigator initiated study at Sweden’s Karolinska Institutet to test COVID-19 pneumonia patients with Unyvero HPN panel for bacterial co-infections

- Rapid diagnostic tests are viewed as critical in this global outbreak response

- Unyvero HPN panel for pneumonia to aid in early detection of hidden and life-threatening bacterial co-infections in COVID-19 patients

GAITHERSBURG, Md. and HOLZGERLINGEN, Germany, April 21, 2020 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, announced today the start of an investigator initiated collaboration with Karolinska Institutet, Sweden, to identify bacterial co-infections in patients admitted to the ICU for COVID-19 pneumonia using the Unyvero HPN panel.

High-risk COVID-19 patients, especially in intensive care units and on ventilation, many of whom may be elderly or have preexisting conditions that compromise their immune system, are at a higher risk of acquiring bacterial co-infections that pose severe life-threatening complications. These co-infections are not always easily determined based on clinical symptoms alone, and, if they go unnoticed or diagnosis is delayed, it can lead to dire outcomes including mortality.

Karolinska Institutet had previously evaluated the Unyvero system and the HPN panel. Curetis has now provided additional Unyvero Analyzers for increased throughput and additional HPN cartridges to enable testing of these critical specimens.

“We are excited about this collaboration which allows us to use the Unyvero HPN multiplexed molecular diagnostic panel to rapidly detect a comprehensive spectrum of clinically relevant bacterial and fungal pathogens and antibiotic resistance markers in lower respiratory tract specimens obtained from critically ill hospitalized ICU patients during this COVID-19 pandemic. We envision the future possibility of running specimens 24/7 in a random access fashion as the samples arrive in the laboratory,” said Professor and Senior Consultant Physician Christian Giske, at the Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.

The Unyvero Hospitalized Pneumonia (HPN) panel detects 21 clinically relevant pathogens and 17 antibiotic resistance markers in less than 5 hours directly from native specimen with only around 2 minutes of hands-on time, compared to routine bacterial cultures that can take up to several days for confirmatory pathogen identification and antimicrobial susceptibility testing results. In the U.S., the Unyvero LRT and LRT BAL panels for rapid detection of lower respiratory tract infections such as pneumonia are FDA-cleared for tracheal aspirate samples and bronchoalveolar lavage fluids, respectively. Unyvero HPN and LRT BAL are the only syndromic pneumonia panels that also include Pneumocystis jirovecii.

“Time is critical when managing a novel virus and bacterial pneumonia co-infections, especially during a pandemic of such grave scale as COVID-19. Rapid multiplex molecular diagnostics can play a crucial role in the fight against the pandemic. We are very pleased about our collaboration with Karolinska Institutet and we sincerely hope that in this way we can contribute to improving the outcomes of COVID-19 patients by way of a comprehensive offering of diagnostic solutions for severe and often life-threatening respiratory tract infections,” said Oliver Schacht, PhD, CEO of OpGen, Inc.

About OpGen, Inc.

OpGen, Inc. (Gaithersburg, MD, USA) is a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease. Along with subsidiaries, Curetis GmbH and Ares Genetics GmbH, we are developing and commercializing molecular microbiology solutions helping to guide clinicians with more rapid and actionable information about life threatening infections to improve patient outcomes, and decrease the spread of infections caused by multidrug-resistant microorganisms, or MDROs. OpGen’s product portfolio includes Unyvero, Acuitas AMR Gene Panel and Acuitas® Lighthouse, and the ARES Technology Platform including ARESdb, using NGS technology and AI-powered bioinformatics solutions for antibiotic response prediction.

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Forward-Looking Statements

This press release includes statements regarding the clinical evaluation of diagnostic tests by subsidiaries of OpGen. These statements and other statements regarding OpGen’s 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, our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product and services offerings, the rate of adoption of our products and services by hospitals and other healthcare 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. 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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