Neonatal Diagnostics Company InfanDx AG Launches US Operations

April 12, 2022 04:00 ET | Source: AKAMPION Cologne, Germany, and Boston, MA, USA, April 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 has set up US operations to gain access to the US market for its HypoxE® Test. The test is…

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OpGen Announces Interim Analysis Results from Clinical Trial for Unyvero Urinary Tract Infection Panel

Download PDF Interim analysis performed with initial 150 U.S. patient samples enrolled in its prospective multicenter trial for the Unyvero UTI panel – Clinical Trial to be continued without any changes Reproducibility Study successfully completed prior to start of enrollment Clinical performance evaluation aims at a subsequent FDA submission ROCKVILLE, Md., April 05, 2022 (GLOBE NEWSWIRE) — OpGen,…

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OpGen Receives FDA Clearance for Acuitas® AMR Gene Panel

ROCKVILLE, Md., Oct. 04, 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 received 510(k) clearance by the U.S. Food and Drug Administration (FDA) to market the Acuitas® AMR Gene Panel, and is finalizing preparations for its swift commercial launch…

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OpGen Initiates Clinical Trial for Unyvero Urinary Tract Infection (UTI) Panel

ROCKVILLE, Md., Sept. 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, announced today that it has initiated the clinical trial for its Unyvero Urinary Tract Infection (UTI) Panel, which allows testing for a broad range of pathogens as well as antimicrobial…

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OpGen Announces Data from Prospective Randomized Controlled Multicenter Clinical Study Using the Unyvero HPN Panel for Hospitalized Patients with Suspicion of Pneumonia

ROCKVILLE, Md., Sept. 15, 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 clinical data from an investigator-initiated and driven prospective randomized controlled multicenter study. Data on the Unyvero HPN was presented at the virtual European Respiratory…

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GBC Contributes to NCI – CPTAC Publication: A Proteogenomic Portrait of Lung Squamous Cell Carcinoma

Published in: CELL | VOLUME 184, ISSUE 16, P4348-4371.E40, AUGUST 05, 2021 Download: PDF [20 MB] Comprehensive proteogenomic characterization of lung squamous cell carcinomas and paired normal adjacent tissues identifies taxonomic subclasses, alternative driver events, and insights into immune modulation, as well as putative biomarkers and potential therapeutic targets. GBC contributed study biospecimens for analysis.

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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…

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OpGen 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…

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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…

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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…

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