ROCKVILLE, Md., Jan. 17, 2023 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, today announced that the Company has received confirmation from FIND, the global alliance for diagnostics, that several key milestones under its collaboration agreement with the global non-profit organization have been successfully met as of the end of 2022. This achievement has triggered an undisclosed milestone payment per the terms of the agreement.
The completed milestone included several key deliverables: successful demonstration of DNA isolation on the Unyvero A30 cartridge from representative bacterial strains in various types of blood culture bottles with subsequent PCR; successful demonstration of several 3-plex assays from the intended panel on the A30 cartridge with both pathogen detection as well as AMR markers; and a detailed set of product requirements for the target product profile, including a list of analytes to be detected which has been defined. OpGen’s subsidiary Curetis furthermore provided a report including results from its internal database analysis looking at genetic diversity and resistance profiles in pathogens observed in low and middle income countries (LMICs). Also, a device specification for a prototype cockpit optimized for use with the A30 platform has been defined and agreed upon.
Andreas Boos, Chief Technology Officer of Curetis and program head for the Unyvero A30 platform development commented, “We are excited about the progress that we have achieved in a few short months since the start of our collaboration with FIND and believe we are on track to achieve the remaining milestones and complete the deliverables under this pilot project as planned until the second quarter of this year.”
Johannes Bacher, Chief Operating Officer of OpGen added that, “given the outstanding results and progress made to date we look forward to a broader and expanded collaboration with FIND once the remaining milestones have been demonstrated. Such a next phase collaboration could include clinical studies as well as projects toward certain regulatory filings in various LMICs.”
Cecilia Ferreyra, Director, FIND AMR Programme remarked that, “the R&D team at OpGen’s subsidiary Curetis has worked to achieve important progress in a short period of time. We are looking forward to seeing and evaluating this molecular point of care test in the coming months as we continue working with the team to evaluate the potential of Unyvero A30 to help identify blood stream infections in patients admitted in LMICs hospitals.”
About OpGen, Inc.
OpGen, Inc. (Rockville, MD, U.S.A.) is a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease. Along with our 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 current product portfolio includes Unyvero, Acuitas AMR Gene Panel, and the ARES Technology Platform including ARESdb, NGS technology and AI-powered bioinformatics solutions for antibiotic response prediction including ARESiss, ARESid, and AREScloud, as well as the Curetis CE-IVD-marked PCR-based SARS-CoV-2 test kit.
For more information, please visit www.opgen.com.
This press release includes statements regarding the Company’s collaboration with FIND. 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. Forward-looking statements may include, without limitation, statements regarding the use of net proceeds therefrom. Factors that could cause our results to differ materially from those described include, but are not limited to, the success of our commercialization efforts, 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 fact that we may not effectively use proceeds from this financing or other financings, the continued realization of expected benefits of our business combination transaction with Curetis GmbH, the continued impact of COVID-19 on the Company’s operations, financial results, and commercialization efforts as well as on capital markets and general economic conditions, our ability to satisfy debt obligations under our loan with the European Investment Bank, the effect of the military action in Russia and Ukraine on our distributors, collaborators and service providers, our liquidity and working capital requirements, the effect on our business of existing and new regulatory requirements, our ability to realize any anticipated benefits from the reverse stock split, including maintaining its listing on the Nasdaq Capital Market and attracting new investors, 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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