In Vitro Diagnostics – IVD News

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…

ROCKVILLE, Md., June 22, 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, reported today that it has enrolled its 1,000th prospective patient sample for its Unyvero Urinary Tract Infection Panel. OpGen’s Unyvero Urinary Tract Infection (UTI) Panel tests for a broad range…

ROCKVILLE, Md., May 26, 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, announced today the release of a new peer-reviewed journal publication from a major investigator-initiated, multicenter, randomized, controlled and interventional trial conducted at two tertiary care centers…

Cologne, Germany, and Boston, MA, USA, May 25, 2022 – InfanDx AG, a privately held diagnostics company focusing on the development and commercialization of novel diagnostic solutions for newborns, announced at an investigator meeting during the recent 48th Annual Meeting of the German Society for Neonatology and Pediatric Intensive Medicine that the clinical 2-year follow-up of…

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…

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.