- Signed contract amendment is part of an overall strategic priority collaboration in the fight against AMR using Unyvero A30 platform in LMICs
- Next phase to cover full AMR assay and cartridge development, analytical testing and software development
- Related payments of up to approximately $0.6 million will bring total collaboration commitment to date to approximately $1.5 million
ROCKVILLE, Md., Aug. 03, 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, reported today that its German subsidiary Curetis GmbH has signed an extended and continued research and development (“R&D”) collaboration agreement with FIND. Following the successful completion of the feasibility phase of the collaboration and having met all milestones on time and within budgets, the parties now plan to collaborate on first phases of product development of an antimicrobial resistance (AMR) cartridge from blood culture that is tailored to the needs of low- and middle-income countries (LMICs) in terms of panel design and coverage of specific genetic variants of bacterial strains and their AMR markers in such countries, as well as ensuring attractive cost profile and pricing models that allow for access to such rapid testing in LMICs.
This extended R&D collaboration now covers the development of an AMR assay and Unyvero A30 cartridge for AMR detection from commonly used blood culture bottles as well as the corresponding software plugin development and full analytical performance evaluation. The expected duration of the development phase is about ten months and the agreed-upon project budget for the extended contract is approximately $0.6 million split into an up-front payment and two milestone payments upon delivery of successful development results. While both Curetis and FIND intend to subsequently take the resulting AMR product into full clinical trials and future regulatory submissions and filings for relevant LMIC countries, these additional project phases would be subject to potential future contract amendments and extensions and will build on the expected results of the development work.
Andreas Boos, Chief Technology Officer at Curetis GmbH and program manager for the Unyvero A30 platform development commented, “We are excited to begin working on this new contract and continue our collaboration project. The assay development and software development teams are already scheduled to initiate their development efforts right away and we expect to work towards the first series of deliverables and milestones later in the fourth quarter of this year.”
Oliver Schacht, Chief Executive Officer of OpGen added, “Following the successful delivery of all milestones on time and within budget during the entire feasibility phase of our collaboration, it is great to now be working on the full IVD development of an AMR product on the A30 platform. With the full development to market launch in various LMICs expected to take a couple of years and estimated to be a multi-million dollar undertaking, we are excited to seamlessly start on this next significant phase of the collaboration with FIND and thereby lay the groundwork for any future clinical trials and regulatory submissions, which we believe could be directly based on the results of a successful assay and cartridge as well as software development and the data we expect from the analytical performance testing.”
Dr. Cecilia Ferreyra, Director, FIND AMR Programme remarked that, “As FIND, we acknowledge the pivotal role played by diagnostics. We are focused on making sure diagnostics are accessible to prevent further development of AMR. The Unyvero A30 platform and the AMR test being developed on it has the potential to meet the requirements for use in low- and middle-income countries. We look forward to working closely with the Curetis team on the next phase of our collaboration to bring high-quality testing for blood stream infections one step closer in LMIC hospitals, to combat antibiotic resistance and ensure that people can be linked to the care they need as soon as possible.”
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, ARESasp, and AREScloud.
For more information, please visit www.opgen.com.
This press release includes statements regarding the extension of Curetis’ collaboration agreement 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. 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 recent financings, 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, 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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