In Vitro Diagnostics – IVD News
OpGen Achieves Key Development Milestone with Curetis Unyvero A30 RQ Platform Program
ROCKVILLE, Md., Aug. 03, 2021 (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 that its subsidiary Curetis GmbH and its instrument development and engineering partner have assembled 10 final pre-series release analyzer instruments of the Unyvero A30 RQ platform. The assembly of the instruments…
Read MoreOpGen Announces Prospective Clinical Data from Unyvero LRT BAL and Acuitas AMR Gene Panel for Isolates Data Presented at World Microbe Forum
GAITHERSBURG, Md., June 30, 2021 (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 prospective clinical data on the Unyvero LRT BAL presented during a webinar held on June 29, 2021, and data presented at the virtual World Microbe Forum, June 20-24, 2021. Download…
Read MoreOpGen Announces Publication of Final Study Results of Unyvero HPN Panel for Diagnosis of Bacterial Co-Infections in ICU Patients with COVID-19 Pneumonia
GAITHERSBURG, Md., and Holzgerlingen, Germany, March 08, 2021 (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 Hospitalized Pneumonia (HPN) panel is a reliable and…
Read MoreOpGen Wins Chinese NMPA Approval for the Curetis Unyvero System
GAITHERSBURG, Md., March 01, 2021 (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 recently received regulatory approval of the Curetis Unyvero System as an in vitro diagnostics (IVD) instrument system in China from…
Read MoreEpigenomics AG Plans to Challenge National Coverage Determination (NCD) Decision and Unveils Its Next Generation Liquid Biopsy Test for Colorectal Cancer Screening
Berlin (Germany) and San Diego, CA (USA), January 21, 2020 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”) announces that the management disagrees and is extremely disappointed with the non-coverage decision for Epi proColon as part of the NCD issued by CMS on Tuesday. While the Company was pleased to see the…
Read MoreUnyvero 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…
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