News

OpGen 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 More

OpGen 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 More

Epigenomics 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 More

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 More

OpGen 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 More

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 More

OpGen 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 More

OpGen 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 More

OpGen 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 More