OpGen Achieves Key Development Milestone in Unyvero A30 RQ Platform Program

Tuesday, 03. August 2021 13:30

- OpGen subsidiary Curetis and its instrument development partner have completed assembly of 10 final pre-series release A30 RQ analyzers

- Unyvero A30 RQ instruments are now readily available for final verification and validation testing

ROCKVILLE, Md., Aug. 03, 2021 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, today announced that its subsidiary Curetis GmbH and its instrument development and engineering partner have assembled 10 final pre-series release analyzer instruments of the Unyvero A30 RQ platform. The assembly of the instruments marks the successful completion of a major development milestone in the Unyvero A30 program. The A30 RQ analyzers will now proceed into final verification and validation testing.

The Unyvero A30 RQ platform is designed to deliver rapid and multiplexed testing results in a fully automated sample-to-answer manner from a wide range of native clinical specimen types. Results from simple samples such as swabs or other simple fluids could be available in under 30 minutes, and results from more complex native specimen might take between 45 to 90 minutes depending on assay specifics. The design of the A30 RQ platform has been optimized to allow for multiplexing up to 33 analytes including controls from a single native sample in a fully integrated cartridge. Given the highly flexible and versatile design of the cartridge technology the Unyvero A30 RQ can address various sample lysis requirements as well as testing for a wide range of DNA and RNA nucleic acid targets. The platform has also been designed for a competitive mix of features such as its multiplexing and rapid time to result, broad compatibility to different nucleic acid purification chemistry and optional quantitative assay formats where needed, all at favorable cost of goods for both the instrument system and the single-use cartridges.

OpGen is evaluating a portfolio of potential future product development programs on the Unyvero A30 RQ platform, including rapid tests for pathogen identification for viruses, bacteria and fungi and a broad range of antimicrobial resistance or AMR marker panels. The portfolio is intended to complement the existing portfolio of highly multiplexed panels on the current Unyvero A50 platform.

Furthermore, the Unyvero A30 RQ platform can be made available to third party development and commercialization partners and licensees for their own assay menu and product portfolio. The Unyvero A30 RQ platform is designed to allow straightforward migration of third party assays using well-established real time PCR technology. Discussions are ongoing at this time with several potential platform partners on various content and licensing or partnering scopes.

Andreas Boos, CTO of Curetis who is leading the Unyvero A30 RQ platform development program overall commented, “Despite very challenging macro environments in the global semiconductor markets and other supply chain shortages, we have been able to deliver the batch of 10 Unyvero A30 RQ analyzers that are now available for a series of well-defined verification and validation tests. The close collaboration with our instrument development and current manufacturing partner for the first series of A30 RQ analyzers has allowed us to keep the program on track and to achieve this key milestone on time and according to plans.”

OpGen CEO Oliver Schacht added, “COVID-19 has demonstrated to the world that rapid and point of care capable platforms can deliver actionable clinical testing results in under 30 minutes where required. Having access to our own flexible and versatile platform will allow us to expand our own product portfolio as well as engage in strategic partnering and licensing discussions that have the potential to leverage and monetize the A30 RQ platform beyond what the capabilities and resources at OpGen would allow us to do on our own.”

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.

For more information, please visit www.opgen.com.

Forward-Looking Statements by OpGen

This press release includes statements regarding the development of OpGen’s Unyvero A30 RQ platform. These statements and other statements regarding OpGen’s Unyvero products, their commercialization and launch, 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 fact that we may not effectively use proceeds from recent financings, the realization of expected benefits of our business combination transaction with Curetis GmbH, the success of our commercialization efforts, the impact of COVID-19 on the Company’s operations, financial results, and commercialization efforts as well as on capital markets and general economic conditions, 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.

OpGen Contact:
Oliver Schacht
CEO
InvestorRelations@opgen.com

Press Contact:
Matthew Bretzius
FischTank Marketing and PR
matt@fischtankpr.com

Investor Contact:
Joe Green
Edison Group
jgreen@edisongroup.com


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