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OpGen, Inc. (NASDAQ: OPGN) is a leader in the field of precision medicine, leveraging advanced molecular diagnostics and bioinformatics to address the pressing issue of infectious diseases. By utilizing their expansive Acuitas Lighthouse® knowledgebase, which contains pathogen data from around the globe, OpGen aims to revolutionize the management of infectious diseases and combat antibiotic resistance.
The company's core offerings include CLIA-certified clinical laboratory services that provide rapid detection and analysis of antibiotic resistance, as well as high-resolution microbial sequence analysis. Their FDA-cleared IVD products are instrumental in identifying pathogens in positive blood cultures swiftly and accurately.
OpGen's groundbreaking products and services are designed to guide healthcare professionals by providing rapid and actionable information about life-threatening infections. This ultimately helps to improve patient outcomes and reduce the spread of infections caused by multi-drug resistant organisms (MDROs). The company’s proprietary DNA tests and informatics tools are pivotal in optimizing care decisions for patients with acute infections.
Among its innovative solutions are the Unyvero platform and the ARES Technology Platform, which includes ARESdb, NGS technology, and AI-powered bioinformatics solutions such as ARESiss, ARESid, ARESasp, and AREScloud. These technologies collectively enhance the ability to predict antibiotic responses and manage infectious threats effectively.
OpGen also collaborates with its subsidiaries, Curetis GmbH and Ares Genetics GmbH, albeit both subsidiaries are currently undergoing insolvency proceedings under German and Austrian laws, respectively. Despite these challenges, OpGen continues to focus on developing and commercializing comprehensive molecular microbiology solutions.
Recent achievements of OpGen include the introduction of new features in their AREScloud technology, the announcement of their second and third-quarter financial results for 2023, and ongoing adjustments to their corporate strategy to navigate the dynamic healthcare landscape.
For more detailed information about the company and its latest developments, visit www.opgen.com.
OpGen, Inc. (Nasdaq: OPGN) announced that its subsidiary, Curetis GmbH, has received CE mark certification for its SARS-CoV-2 Kit with PULB, enabling effective COVID-19 testing in Europe. This kit utilizes real-time PCR technology and boasts 100% sensitivity and 97.3% specificity. Designed for rapid results in about one hour, it streamlines laboratory workflows by minimizing the need for extraction equipment due to the inclusion of a universal lysis buffer. The company aims to enhance testing capacity in CE-mark-recognizing countries, replacing the BGI SARS-CoV-2 test kit immediately.
OpGen, Inc. (Nasdaq: OPGN) reported Q2 2020 revenue of approximately $1.2 million, up from $1.0 million in Q2 2019. Cash on hand increased to $12.9 million from $11.5 million in Q1 2020. The company announced a strategic co-promotion partnership with Menarini Silicon Biosystems for COVID-19 products, enhancing its market presence. However, Q2 operating expenses surged to $7.7 million from $3.6 million, resulting in a net loss of $7.5 million or $0.49 per share.
OpGen, Inc. (NASDAQ: OPGN) has initiated a non-exclusive co-promotion agreement with Menarini Silicon Biosystems to market select products to healthcare providers in the U.S., Canada, and Mexico. Key products include the CELLSEARCH system and a COVID-19 IgG/IgM Rapid Test, which provides results in 10 minutes and has received FDA emergency use authorization. Under the agreement, OpGen will earn payments based on MSB’s net sales from referrals. The collaboration aims to broaden the COVID-19 product portfolio offered by OpGen.
OpGen, Inc. (NASDAQ: OPGN) will provide a business update and report its second quarter 2020 financial results on August 12, 2020, after market close. A live conference call and audio webcast will be hosted at 4:30 PM ET to discuss these results and business activities. Investors can join the call using the U.S. dial-in number +1 (877) 705 6003 or the international number +1 (201) 493 6725. A replay will be available until August 26, 2020, for those unable to attend the live session.
OpGen has formed a strategic partnership with Menarini Silicon Biosystems to co-promote the CELLSEARCH Circulating Endothelial Cell Kit and other COVID-19 related products. Effective immediately, OpGen will market these products to healthcare providers in North America. This partnership aims to enhance the understanding of COVID-19 progression through CEC enumeration, potentially identifying patients at risk of severe complications. Both companies plan to expand their portfolio of COVID-19 products in the upcoming months.
OpGen announced an amendment to its EIB financing agreement allowing its subsidiary Curetis GmbH to access an additional EUR 5 million for COVID-19 related R&D. This non-dilutive debt will fund various platforms over a five-year interest-only period. The drawdown is at Curetis' discretion within nine months, with a 0.7% participation interest in OpGen's equity at maturity, expected between H2-2025 and early 2027. CEO Oliver Schacht emphasized the importance of this funding in advancing R&D efforts against infectious diseases.
OpGen announced preliminary data demonstrating a 98.2% concordance rate of its Unyvero HPN Panel for pneumonia when compared to bacterial culture in identifying pathogens in COVID-19 ICU patients. The study, conducted with Karolinska Institutet, highlighted that 25% of patients had bacterial co-infections. The Unyvero system provided results in five hours instead of days, enabling quicker treatment decisions and supporting antimicrobial stewardship. The panel detects 21 pathogens and 19 resistance markers, significantly improving time-sensitive diagnosis for critical patients.
OpGen is entering the second year of its collaboration with the New York State Department of Health to enhance the detection and management of antimicrobial-resistant infections. The project will utilize the Acuitas® AMR Gene Panel and Acuitas Lighthouse® Software across multiple healthcare institutions. The total contract value is up to $450,000, including 3,500 tests. OpGen aims to improve patient outcomes and save healthcare costs by integrating real-time surveillance and rapid resistance results. This project expands on successful pilot phase achievements, with an emphasis on molecular epidemiology for early outbreak identification.
OpGen, Inc. (Nasdaq: OPGN) has introduced its new CEO Oliver Schacht and Chairman William Rhodes in letters to shareholders. The company is focused on integrating its business with the recent acquisition of Curetis and Ares Genetics while pursuing growth and operational efficiency. Key milestones include the anticipated FDA clearance for the Acuitas AMR Gene Panel and the launch of the Unyvero A30 RQ platform. OpGen aims to leverage AI-powered diagnostics to combat antibiotic resistance and enhance stockholder value through innovative solutions and strategic partnerships.
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