In Vitro Diagnostics – IVD News
OpGen Issues Formal Response to FDA’s Requests for Additional Information and Expects Near Term FDA Clearance Decision for Acuitas AMR Gene Panel
GAITHERSBURG, Md., Oct. 13, 2020 (GLOBE NEWSWIRE) — OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, announced today that it has issued its formal response to the second of the FDA’s AI Requests (Additional Information Request) for the Acuitas AMR Gene…
Read MoreOpGen Announces Award of German Government Grant Funding to its Subsidiary Curetis and Collaborators
GAITHERSBURG, Md., and HOLZGERLINGEN, Germany, Sept. 30, 2020 (GLOBE NEWSWIRE) — OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, announced today the award of a German Federal Government grant to its subsidiary, Curetis GmbH, and collaborators at the Research Campus InfectoGnostics. The project is coordinated by Jena University…
Read MoreOpGen Group Company Ares Genetics Nominated for Austrian Innovation Award for AI-powered Molecular Antibiotic Susceptibility Test
VIENNA, Austria, and GAITHERSBURG, Md., Sept. 08, 2020 (GLOBE NEWSWIRE) — OpGen, Inc. (Nasdaq: OPGN, “OpGen”), announced today that its subsidiary Ares Genetics GmbH (Vienna, Austria; “Ares Genetics”) has been nominated for the 40th Austrian Innovation Award (Ref. 1). Ares Genetics has been selected by an expert jury as one of six finalists for its…
Read MoreOpGen Announces CE-IVD Marking and Commercial Launch in Europe of its Own Developed Molecular Diagnostic SARS-CoV-2 Kit with PULB for Detection of the Virus Causing COVID-19
GAITHERSBURG, Md., and HOLZGERLINGEN, Germany, Aug. 20, 2020 (GLOBE NEWSWIRE) — OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, announced today that its subsidiary Curetis GmbH has obtained the CE mark certification in the European Union for its own SARS-CoV-2 Kit with PULB for the detection of SARS-CoV-2, the virus…
Read MoreNew Study Published in the Journal of the National Cancer Institute Concludes that Epi proColon® is the Test of Choice for the Millions of Individuals Not Willing to Participate in FIT or Colonoscopy Screening
BERLIN and SAN DIEGO, Aug. 10, 2020 (GLOBE NEWSWIRE) — Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”) announces that a study published by the NCI-sponsored cancer intervention and surveillance modeling network (CISNET) in the Journal of the National Cancer Institute reported that by comparing the incremental cost-effectiveness of CTC, PillCam, mtSDNA (Cologuard)…
Read MoreOpGen Group Company Ares Genetics Demonstrates Feasibility of CLIA-compliant Next Generation Sequencing Workflow for Identification of Bacterial Pathogens and Antibiotic Resistance Markers
VIENNA, Austria, and GAITHERSBURG, Md., Aug. 11, 2020 (GLOBE NEWSWIRE) — Ares Genetics GmbH (Vienna, Austria; “Ares Genetics”), a subsidiary of OpGen, Inc. (Nasdaq: OPGN, “OpGen”), announced today the publication of a peer-reviewed study that demonstrates the feasibility of a highly accurate and reproducible sample-to-insight workflow for various clinical microbiology assays including the molecular identification…
Read MoreOpGen Co-Markets COVID-19 Antibody Test Kit
GAITHERSBURG, Md., Aug. 09, 2020 (GLOBE NEWSWIRE) — As disclosed in OpGen, Inc.’s (NASDAQ: OPGN) (“OpGen” or “the Company”) July 13, 2020 press release, we have commenced marketing and promotion, on a non-exclusive basis, of certain products offered by Menarini Silicon Biosystems (MSB) to infectious disease healthcare providers and researchers. As part of the co-promotion…
Read MoreMenarini Silicon Biosystems Partners with OpGen to Broaden Distribution of CELLSEARCH Platform in North America
BOLOGNA, Italy and HUNTINGDON VALLEY, Pa. and GAITHERSBURG, Md., July 13, 2020 (GLOBE NEWSWIRE) — OpGen, Inc. (Nasdaq: OPGN), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, announced today that it has entered into a strategic co-promotion partnership with Menarini Silicon Biosystems (MSB), the pioneer of…
Read MoreOpGen Unyvero Hospitalized Pneumonia (HPN) Panel Rapidly Identifies Bacterial Coinfections in COVID-19 Pneumonia
19-JUN-2020 (https://www.infectiousdiseaseadvisor.com/) The Unyvero HPN panel provides comprehensive diagnostic information to clinicians in less than 5 hours, with only minutes of actual hands-on time. The Unyvero Hospitalized Pneumonia (HPN) panel (OpGen, Inc., Gaithersburg, MD) identifies bacterial coinfections in <5 hours in hospitalized patients with coronavirus disease 2019 (COVID-19) pneumonia, according to a news release on…
Read MoreOpGen Expands Partnership With New York State Department of Health to Detect Antimicrobial Resistant (AMR) Infections
GenomeWeb – NEW YORK – OpGen announced Wednesday the expansion of its strategic collaboration with the New York State Department of Health after the firm hit all of its milestones under the first-year contract. As a result, the collaboration is proceeding into a second-year contract. The collaboration’s goal is to develop a solution to detect,…
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