OpGen Acuitas ® MDRO Gene Test Approved by NY State Department of Health

GAITHERSBURG, Md., July 12, 2017 -- OpGen, Inc. (NASDAQ:OPGN) announced today that the New York State Department of Health (NYSDOH) has approved the Acuitas® MDRO Gene Test for use by physicians and healthcare providers in the state. The approval of OpGen’s CLIA laboratory to perform testing in New York State includes approval for the complete OpGen MDRO testing workflow, including MDRO gene testing on perianal swabs and clinical isolates. The NYSDOH regulates and oversees clinical diagnostic laboratories that test specimens from the state residents.

 

The Acuitas MDRO Gene Test is a CLIA lab-based test able to provide information regarding the presence of ten MDRO resistance genes from one patient specimen. The ten drug-resistant genes identified by our Acuitas MDRO Gene Test are associated with CRE, ESBL and VRE organisms, and are gastrointestinal organisms frequently associated with antibiotic-resistant infections. The test results can be used by healthcare providers to identify patients colonized with organisms expressing the drug-resistant genes or who are actively infected.

 

Evan Jones, Chairman & CEO, commented, “We are pleased to receive approval by the NYSDOH to provide our services to healthcare institutions in NY State. The NY State Clinical Lab Evaluation Program conducts rigorous evaluations of new clinical lab tests, and we are honored to receive this important approval for our technology. By making our testing available to NY State healthcare providers, we hope to help combat the rising Superbug Multi-drug Resistant pathogen issue.”

 

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 influenced 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 harnessing the power of informatics and genomic analysis to provide complete solutions for patient, hospital and network-wide infection prevention and treatment. Learn more at www.opgen.com and follow OpGen on Twitter and LinkedIn.

 

OpGen, Acuitas, Acuitas Lighthouse and QuickFISH are registered trademarks of OpGen, Inc.

 

Forward-Looking Statements

This press release includes statements relating to the Company's products and services. 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 (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.

 

OpGen Contact:

Michael Farmer

Director, Marketing

240-813-1284

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Investor Contact:

LHA Investor Relations

Kim Sutton Golodetz

212-838-3777

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or

Bruce Voss

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