OpGen Subsidiary Ares Genetics Successfully Maintains Key Patent under Opposition in Europe

• Patent EP 3 332 028 B1 granted by the European Patent Office covers the identification and use of genomic variants for the diagnosis of antibiotic resistant bacteria.
• The opposition division of European Patent Office ruled to maintain the patent as granted with minor modifications.

ROCKVILLE, Md., June 26, 2023 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease, and OpGen subsidiary, Ares Genetics, which strives to become a leader in bacterial genomics and AI-powered prediction of antimicrobial resistance (AMR), announced today that one of its key patents under opposition has been successfully maintained.

The patent with the title GENETIC RESISTANCE PREDICTION AGAINST ANTIMICROBIAL DRUGS IN MICROORGANISM USING STRUCTURAL CHANGES IN THE GENOME was granted in Europe on January 6, 2021 and in China on January 10, 2023.

In September 2021, an opposition was filed by a Swedish opponent against the patent grant by the European Patent Office. In a hearing on Thursday, June 22, 2023, the opposition division of the European Patent Office ruled in favor of maintaining the patent as granted with a minor amendment to one of the claims.

The patent as maintained broadly covers the prediction of AMR in pathogens based on any genetic determinants involving two or more nucleotides.

The patent is an important component of the comprehensive intellectual property portfolio protecting Ares Genetics' unique database ARESdb and machine learning based approaches for predicting phenotypic antibiotic susceptibility and resistance directly from genomic data, an approach also referred to as “genomic AST.” Under the patent, both the computational identification of genetic determinants of AMR and genomic AST can be carried out, in order to diagnose AMR infections in patient samples.

“The patent covers the use of alignment-free methods, which are not only more computing resource efficient, but are also generally required to discover and resolve more complex structural variants, which is particularly important in this context,” says Dr. Arne Materna, CEO and Managing Director of Ares Genetics. “We therefore welcome the favorable ruling by the European Patent Office, an outcome that we believe underscores the validity, novelty and potential value of similar pending patent applications in our portfolio.”

OpGen believes that bacterial whole genome sequencing (WGS) is becoming the method of choice for detecting and controlling healthcare associated outbreaks. Genomic AST as covered in the patent has the potential to expand the utility of WGS beyond outbreak-surveillance into the realm of diagnostic applications to inform therapy.

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, as well as the Curetis CE-IVD-marked PCR-based SARS-CoV-2 test kit.

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Forward-Looking Statements

This press release includes statements regarding the decision to maintain a key patent of Ares Genetics granted by the European Patent Office. 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.

OpGen:

Oliver Schacht

President and CEO

OpGen Investor & Press Contact:

Alyssa Factor

Edison Group