OpGen Submits De Novo Request to the U.S. FDA for Unyvero Urinary Tract Infection (UTI) Panel

ROCKVILLE, Md., April 18, 2023 (GLOBE NEWSWIRE) — OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, today announced that it has submitted a De Novo classification request to the U.S. Food and Drug Administration (FDA) seeking marketing authorization for its Unyvero UTI Urinary Tract Infection (UTI)…

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OpGen Announces Positive Top Line Data from Clinical Trial for Unyvero Urinary Tract Infection (UTI) Panel

ROCKVILLE, Md., Dec. 13, 2022 (GLOBE NEWSWIRE) — OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, today announced top line data from its successfully completed Unyvero UTI clinical trial. OpGen’s Unyvero UTI Panel tests for a broad range of bacterial and fungal pathogens as…

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InfanDx Tackles Early Detection of Hypoxic Ischemic Encephalopathy

InfanDx AG, a privately held diagnostics company focusing on the development and commercialization of novel diagnostic solutions for newborns, has completed the validation of metabolic biomarker panels for the early detection of hypoxic ischemic encephalopathy (HIE) in newborns.  The validated biomarkers of such panels will be the target of the company’s HypoxE blood test for…

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OpGen Subsidiary Curetis and BioVersys Sign Collaboration Agreement for Clinical Trial Support – BV100/Rifabutin to Treat Carbapenem Resistant Acinetobacter baumannii (CRAB) Infections

ROCKVILLE, Md. and BASEL, Switzerland, Oct. 25, 2022 (GLOBE NEWSWIRE) — OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, and BioVersys AG, a privately-held clinical stage, multi-asset Swiss pharmaceutical company focusing on research and development of small molecules for multidrug-resistant bacterial infections with applications in…

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InfanDx AG Reports Successful Validation of Biomarker Panels for the Early Detection of Hypoxic Ischemic Encephalopathy

Cologne/Berlin, Germany, and Boston, MA, USA, October 12, 2022 – InfanDx AG, a privately held diagnostics company focusing on the development and commercialization of novel diagnostic solutions for newborns, today announced that it successfully completed the validation of metabolic biomarker panels for the early detection of Hypoxic Ischemic Encephalopathy (HIE) in newborns. The validated biomarkers of such…

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OpGen Announces Successful Completion of Clinical Trial Enrollment for Unyvero Urinary Tract Infection Panel

ROCKVILLE, Md., Oct. 03, 2022 (GLOBE NEWSWIRE) — OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, today announced its successful completion of patient enrollment for its clinical trial for the Unyvero Urinary Tract Infection (UTI) Panel. OpGen’s Unyvero UTI Panel tests for a broad range…

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European Companies Poised to Gain as EU Commission Blocks Illumina-Grail Deal

Innovation competition between early cancer detection test developers is in the spotlight due to the European Commission blocking Illumina’s bid to buy Grail. More than 20 companies in Europe developing liquid biopsy tests may benefit from the recent European Commission decision to prohibit Illumina’s acquisition of Grail in the EU. The GlobalData MIC Pipeline Products…

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OpGen Subsidiary Curetis and FIND Sign R&D Collaboration Agreement for Unyvero A30 RQ Platform

ROCKVILLE, Md., Sept. 20, 2022 (GLOBE NEWSWIRE) — OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, today announced the signing of an R&D collaboration agreement with FIND, the global alliance for diagnostics, for the Unyvero A30 RQ platform for use in rapid pathogen ID and…

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OpGen Launches Ares Sequencing Services in the U.S. from its Rockville, Maryland Laboratory

ROCKVILLE, Md., Aug. 25, 2022 (GLOBE NEWSWIRE) — OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease, announced today that it has launched next generation sequencing (NGS) services in the U.S. that were developed by its subsidiary, Ares Genetics (“Ares”), which strives to become a…

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ELITechGroup and InfanDx AG to Collaborate on the Development and Manufacturing of HypoxE® Neonatal Care Test for Clinical Laboratories

Chicago, IL, USA, July 27, 2022 – ELITechGroup and InfanDx AG today announced at the ongoing 2022 AACC Annual Scientific Meeting & Clinical Lab Expo in Chicago, IL, USA, the signing of a Memorandum of Understanding (MoU) to collaborate on the development and manufacturing of InfanDx’ HypoxE® Test for ELITechGroup’s family of Selectra Pro clinical chemistry analyzers. The parties intend…

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