In Vitro Diagnostics – IVD News
Unyvero LRT BAL Panel Provides Accurate Detection in Bronchoalveolar Lavage (BAL) Fluid, Allowing Enhanced Diagnosis of Lower Respiratory Tract Infections
GAITHERSBURG, Md. and HOLZGERLINGEN, Germany, Dec. 17, 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, today announced the release of a new peer-reviewed publication that demonstrates that the Unyvero LRT BAL panel accurately detects 19 bacteria alongside…
Read MoreWorld’s Fastest PCR-Based SARS-CoV-2 Test Now Available on Randox-Bosch Vivalytic POC Analyzer
29 Oct 2020. A rapid new coronavirus test, which provides results for COVID-19 in just 39 minutes, is now available on the Vivalytic, a point of care platform brought to market by Randox Laboratories (Crumlin, UK) and Bosch Healthcare (Waiblingen, Germany). The test for detection of the SARS-CoV-2 pathogen, is currently the fastest PCR test…
Read MoreOpGen Announces Award of German Government Grant Funding to its Subsidiary Curetis and Collaborators
GAITHERSBURG, Md. and HOLZGERLINGEN, Germany, Oct. 28, 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 Carpegen GmbH (Muenster, Germany) and…
Read MoreOpGen 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…
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