GAITHERSBURG, Md., Oct. 23, 2019 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN) announced today that the United States Patent and Trademark Office (the “USPTO”) has allowed a key OpGen patent covering the Lighthouse Profiling technology used in the company’s software for tracking antimicrobial resistant pathogens. Patent application US 20160085912A1 “Systems, Apparatus, and Methods for Generating and Analyzing Resistome Profiles” covers the use of the company’s Acuitas Lighthouse® Software for real-time monitoring of superbug infections and other multi-drug resistant infections. The final patent is expected to be issued in the coming weeks.
The Lighthouse Software was developed for use with the Acuitas® AMR Gene Panel for testing bacterial isolates. In May 2019OpGen filed a 510(k) submission for the Acuitas AMR Gene Panel for testing with bacterial isolates. The Acuitas AMR Gene Panel test provides results in under three hours that can be uploaded to the cloud in real-time for analysis using the Acuitas Lighthouse Profiling technology. The Lighthouse software automatically generates real-time alerts, when the degree of similarity between pathogens is above a threshold indicating a potential outbreak or a common source of infection such that the patient can be contained. The Lighthouse Software is currently available for Research Use Only and is not for use in diagnostic procedures. The company is currently involved in a demonstration project evaluating the use of real-time genomic profiling for hospital and statewide surveillance to help control antimicrobial resistance.
Evan Jones, Chairman and CEO of OpGen commented, “We are pleased the USPTO has recognized the novelty of this key component of our Acuitas Lighthouse Software. This is the first patent to be allowed in a broader family of patent applications covering prediction of antibiotic resistance and Acuitas AMR Gene Panel for rapid DNA testing. We are preparing to deploy this technology in hospitals throughout the United States with FDA-cleared products with a goal of improving patient outcomes and helping to address the rise of serious drug-resistant antimicrobial infections.”
About Antimicrobial-resistant Infections
The Centers for Disease Control and Prevention (“the CDC") estimates that annually in the United States we face 2 million illnesses, 23,000 deaths and $35 billion in lost productivity – all attributable to antibiotic resistant infections. Among the infectious diseases OpGen is working to address are carbapenem-resistant Enterobacteriaceae (CRE) bacteria; they are untreatable and hard-to-treat infections on the rise among patients in medical facilities. CREs have become resistant to all or nearly all the antibiotics we have today. Almost half of hospital patients who get bloodstream infections from CRE bacteria die from the infection. The CDC has classified CREs as one of three urgent threats to the public health.
OpGen, Inc. is a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease. We are developing molecular information products and services for global healthcare settings, helping to guide clinicians with more rapid and actionable information about life threatening infections, improve patient outcomes, and decrease the spread of infections caused by multidrug-resistant microorganisms, or MDROs.
Our molecular diagnostics and informatics products, product candidates and services combine our Acuitas® molecular diagnostics and Acuitas Lighthouse® informatics platform for use with our proprietary, curated MDRO knowledgebase. We are working to deliver our products and services, some in development, to a global network of customers and partners. The Acuitas AMR Gene Panel (RUO) is available for Research Use Only and is 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. For more information, please visit www.opgen.com.
OpGen, Acuitas, and Acuitas Lighthouse are registered trademarks of OpGen, Inc.
This press release describes the patent allowed by the USPTO and OpGen’s plans with respect to its future products. These statements 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 the future to differ materially from expectations. We cannot assure you that there will not be a delay in the formal issuance of the patent, that we will receive FDA clearance for our isolates product, and future products for which we intend to submit 510(k) applications to the FDA or that our products will be adopted by hospitals for use in treatment of antibiotic-resistant infections. 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.
Vice President, Marketing
FischTank Marketing and PR
Source: OpGen, Inc.