In Vitro Diagnostics – IVD News

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,…

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…

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…

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…

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.

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…

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…

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…

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…

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…