GAITHERSBURG, Md., Oct. 31, 2018 (GLOBE NEWSWIRE) -- OpGen, Inc. (NASDAQ: OPGN) today announced a collaboration with QIAGEN N.V. to advance rapid diagnostics for antimicrobial resistance (AMR). Strengthening OpGen’s entry into the United States market, the companies have entered into an agreement to commercialize a new solution for the detection of multidrug resistant bacterial pathogens based on QIAGEN’s EZ1 Advanced XL automated nucleic acid purification instrumentation (EZ1) and kits for the United States. The EZ1 will be utilized in the test workflow for the Acuitas® AMR Gene Panel u5.47 products. The AMR Gene Panel family of rapid diagnostics tests has been designed to detect and identify multidrug-resistant bacterial pathogens in urine and bacterial isolates in approximately two hours. The test was developed for use with the Acuitas Lighthouse® Software for predicting antibiotic resistance and high-resolution pathogen tracking. The AMR Gene Panel u5.47 and the Acuitas Lighthouse Software are currently available for Research Use Only (RUO).
Under the terms of the agreement, OpGen will purchase EZ1 instruments and reagent kits from QIAGEN and sell or place them with customers in the United States for use with the Acuitas AMR Gene Panel. The EZ1 is a Class I Medical Device listed with the Food and Drug Administration (FDA) that provides full automation with sample preparation throughput of up to 14 samples per one-hour run. QIAGEN is the global leader for nucleic acid sample preparation with a full line of instruments and reagents including the EZ1, the QIAcube, and the QIAsymphony fully integrated automation. There are thousands of EZ1 instruments currently used in laboratories worldwide.
“We are pleased to collaborate with QIAGEN to further strengthen our AMR Gene Panel offering,” said Evan Jones, Chairman and CEO of OpGen. “The EZ1 provides best in class nucleic acid purification technology, and QIAGEN’s extensive global commercial capabilities and diagnostic expertise should provide multiple opportunities for collaboration in the future.”
“We are pleased that OpGen is incorporating the EZ1 as part of their AMR Gene Panel test offering,” said Thierry Bernard, SVP Molecular Diagnostics Business Area, QIAGEN. “The partnership further expands the menu for EZ1 and adds a new and rapid diagnostic solution in the crucial fight against AMR.”
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. For more information, please visit www.opgen.com.
OpGen, Acuitas, Acuitas Lighthouse, and QuickFISH are registered trademarks of OpGen, Inc.
The Acuitas AMR Gene Panel u5.47 (RUO) and the Acuitas Lighthouse Software (RUO) are intended for Research Use Only and are not for use in diagnostic procedures. The Acuitas Lighthouse Software is not distributed commercially for antibiotic resistance prediction and is not for use in diagnostic procedures.
OpGen Forward-Looking Statements
This press release includes statements relating to OpGen’s reseller agreement with QIAGEN. 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, our ability to successfully complete the pilot portion of this project, the rate of adoption of our products and services by hospitals and other healthcare providers, 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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