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118 articles with OpGen, Inc.
OpGen, Inc. announced that its subsidiary Ares Genetics, which strives to become a leader in bacterial genomics and the AI-powered prediction of antimicrobial resistance, is developing a culture-free, genomic assay for comprehensive AMR surveillance.
OpGen Announces Partial Adjournment of Annual Meeting for Proposal 2 with All Other Proposals Passed
OpGen, Inc. (Nasdaq: OPGN, “OpGen” or the “Company”), today announced that the Company conducted its 2021 annual stockholders meeting (the “Annual Meeting”) and adjourned the meeting solely with respect to Proposal 2 set forth in its Definitive Proxy Statement (the “Proxy Statement”) filed with the Securities and Exchange Commission on April 26, 2021.
OpGen Submits Updated 510(k) Summary to FDA and Successfully Completes Move to New Headquarters in Maryland
OpGen, Inc., a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease, announced that it has submitted an updated 510 summary document to the U.S. FDA for its Acuitas AMR Gene Panel for Isolates.
OpGen, Inc., a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, reported its financial and operating results for the three months ended March 31, 2021 and provided a business update.
OpGen to Provide Business Update and Financial Results for the First Quarter 2021 on May 13th at 8:30 a.m. Eastern Time
OpGen, Inc. (NASDAQ: OPGN) (“OpGen” or “the Company”) announced today that the Company will provide a business update and report its first quarter 2021 financial results before the open of the U.S. financial markets on Thursday, May 13, 2021.
OpGen Extends and Expands Partnership with New York State Department of Health to Detect Antimicrobial-Resistant Infections
Collaboration with NYS Department of Health’s Wadsworth Center continues for extended six-month term until September 30, 2021 Project utilizes OpGen’s Acuitas® AMR Gene Panel and Acuitas Lighthouse® Software within digital health and precision medicine platform at multiple healthcare institutions
OpGen Announces Results from Successful Webinar on Bacterial Pneumonia Co-infections in COVID-19 Patients
Experts presented the results of their Unyvero studies and demonstrated: Distinguishing those COVID-19 ICU patients with bacterial superinfection early and accurately is crucial for patient management and antibiotic stewardship Unyvero detected bacterial pathogens up to 7 days earlier and would have enabled prompt and appropriate targeted antibiotics in 41.3% of cases and reduced time to appropriate therapy by 25.7 hours
Total combined pro-forma revenue for 2020 was approximately $5.2 million Maintained strong balance sheet with $13.4 million cash as of December 31, 2020 Raised an additional $34.7 million of capital in the first quarter of 2021 Conference call to be held at 4:30 p.m. Eastern Time today
OpGen, Inc. (NASDAQ: OPGN) (“OpGen” or “the Company”) announced today that the Company will provide a business update and report its fourth quarter and full year 2020 financial results after the close of the U.S. financial markets on Thursday, March 25, 2021.
OpGen Announces Publication of Final Study Results of Unyvero HPN Panel for Diagnosis of Bacterial Co-Infections in ICU Patients with COVID-19 Pneumonia
OpGen today announced the release of a new peer-reviewed publication that demonstrates that the Unyvero Hospitalized Pneumonia (HPN) panel is a reliable and rapid diagnostic test with high negative predictive value for the detection of bacterial pathogens directly from native lower respiratory tract samples, allowing identification of bacterial co-infections in hospitalized patients with COVID-19 pneumonia in just five hours.
Chinese regulatory authority NMPA completes registration of Unyvero instrument system as IVD for Chinese market Application of Unyvero cartridge for pneumonia is under review and pending NMPA approval OpGen’s subsidiary Curetis and its Chinese partner Beijing Clear Biotech continue working with the NMPA towards approval of pneumonia test in China
Preliminary total pro-forma combined revenue for 2020 was approximately $5.2 million Maintained strong balance sheet with $13.3 million cash as of December 31, 2020 and total capital raised in 2020 of $35.3 million OpGen subsidiary Ares Genetics to explore multiple collaboration opportunities with several parties
OpGen, Inc., a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, announced that its subsidiary Curetis GmbH has entered into a distribution agreement with Annar Health Technologies for Colombia.
Results from 1,400 Patient Sample Multicenter Study Published: Unyvero LRT BAL Panel Provides Accurate Detection in Bronchoalveolar Lavage Fluid, Allowing Enhanced Diagnosis of Lower Respiratory Tract Infections
Early diagnosis and proper choice of antimicrobials are crucial for successful management of pneumonia Study demonstrates Unyvero LRT BAL provides accurate detection of common agents of bacterial pneumonia and of Pneumocystis jirovecii in ~4.5 hours Performance data, comprehensive coverage and fast time to result of this panel suggest significant clinical value for choosing appropriate antibiotics and for antibiotic stewardship
OpGen Announces Planned Leadership Transition at Next Generation Sequencing and Bioinformatics Subsidiary Ares Genetics
Dr. Andreas Posch, while stepping down as Managing Director and CEO to pursue new opportunities, remains on board throughout 2021 as special advisor to facilitate smooth transition
OpGen Group Company Ares Genetics Advances ares-genetics.cloud Platform, Presents Update at Scientific Conferences, Expects Granting of Key Patent
Extended collaboration with leading global generics company Sandoz for optimal antibiotic drug positioning by predictive antibiotic susceptibility testing
OpGen Group Company Ares Genetics Commercially Launches NGS-based Antibiotic Resistance Testing Service for Native Specimens and Receives Bulk Order from Public Health Agency
Early access program launched for the next generation of the ARESupa Universal Pathogenome Assay based on targeted next-generation sequencing (NGS) of native specimens
OpGen, Inc. (NASDAQ: OPGN) (“OpGen” or “the Company”) announced today that the Company will provide a business update and report its third quarter 2020 financial results after the close of the U.S. financial markets on Wednesday, November 11, 2020. OpGen’s management team will host a live conference call and audio webcast at 4:30 p.m. Eastern Time to discuss the Company’s financial results and provide an update on business activities. C
OpGen Provides Business and Pipeline Update and Announces Preliminary Unaudited Revenue and Cash Position for the Third Quarter 2020
OpGen takes strategic steps to expand the Unyvero platform and product pipeline , to focus on the pending Acuitas AMR Gene Panel (isolates) FDA clearance and expects to invest significantly in bioinformatics OpGen subsidiary Ares Genetics received notification of exercise of option to negotiate for a potential future license by its IVD Partner OpGen to d iscontinue Acuitas AMR Gene Panel (urine) clinical trial and discontinue FISH product line globally by
OpGen Issues Formal Response to FDA’s Requests for Additional Information and Expects Near Term FDA Clearance Decision for Acuitas AMR Gene Panel
OpGen’s Acuitas AMR Gene Panel allows testing for a very comprehensive panel of more than 40 diagnostic targets (pathogens and genetic AMR markers) in pure bacterial colonies