News

Curetis Launches Recently FDA-cleared Unyvero Lower Respiratory Tract (LRT) Pneumonia Pathogen Panel for Bronchoalveolar Lavage (BAL) Specimens in the U.S.

Amsterdam, the Netherlands, Holzgerlingen, Germany, and San Diego, CA, USA, January 14, 2020, 08:00 am CET — Curetis N.V. (the “Company” and, together with its subsidiaries, “Curetis”), a developer of next-level molecular diagnostic solutions, today announced the U.S. launch of its Unyvero LRT BAL Lower Respiratory Tract Application Cartridge for use with bronchoalveolar lavage (BAL)…

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Curetis Receives U.S. FDA 510(k) Clearance of Unyvero Lower Respiratory Tract (LRT) Test Cartridge for Bronchoalveolar Lavage (BAL) Specimens

Amsterdam, the Netherlands, Holzgerlingen, Germany, and San Diego, CA, USA, December 20, 2019, 23:30 CET — Curetis N.V. (the “Company” and, together with its subsidiaries, “Curetis”), a developer of next-level molecular diagnostic solutions, today announced that the Company has received 510(k) clearance by the U.S. Food and Drug Administration (FDA) to market its Unyvero LRT…

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Ares Genetics, a Curetis Group Company, Joins NVIDIA Inception and Amazon Web Services (AWS) Activate Programs

Vienna, Austria, and Holzgerlingen, Germany, December 10, 2019, 08:00 am CET – Curetis N.V. (the “Company” and, together with its subsidiaries, “Curetis”), a developer of next-level molecular diagnostic solutions, today announced that its fully-owned subsidiary Ares Genetics has joined the NVIDIA Inception program as a community member. The Inception program is designed to nurture start-ups…

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Epigenomics AG Reports on New Micro-Simulation Study Results Published in Cancer Medicine Indicating That Epi proColon® Provides Clinically Meaningful Reductions in Incidence and Mortality of Colorectal Cancer

BERLIN, Dec. 02, 2019 (GLOBE NEWSWIRE) — Epigenomics AG (FSE: ECX, OTCQX: EPGNY; the “Company”), today reported on micro-simulation model results indicating that Epi proColon®, a colorectal cancer (CRC) screening test approved for patients who are unwilling or unable to be screened by the United States Preventive Services Task Force (USPSTF) recommended methods, provides clinically…

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Curetis Expects Near-Term U.S. FDA Decision on 510(k) Clearance of Unyvero LRT for BAL Specimens

Amsterdam, the Netherlands, Holzgerlingen, Germany, and San Diego, CA, USA, November 25, 2019, 08:00 am CET — Curetis N.V. (the “Company” and, together with its subsidiaries, “Curetis”), a developer of next-level molecular diagnostic solutions, today announced that the Company has filed its formal response to the FDA’s AI (Additional Information request letter regarding the Company’s…

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FDA Grants De Novo Designation for Vela Diagnostics’ Next Generation Sequencing HIV-1 Genotyping Assay

Vela Diagnostics’ Sentosa® SQ HIV-1 Genotyping Assay is the first FDA De Novo designated Next Generation Sequencing (NGS) assay for detecting HIV-1 drug resistance mutations (DRMs). November 06, 2019 08:00 AM Eastern Standard Time FAIRFIELD, N.J.–(BUSINESS WIRE)–Vela Diagnostics announced today that it has received FDA authorization to market its in vitro diagnostic test for the detection of HIV-1 genomic…

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Curetis Group Company Ares Genetics Launches AI-powered Molecular Antibiotic Susceptibility Test

Vienna, Austria, and Holzgerlingen, Germany, October 28, 2019, 08:00 am CET – Curetis N.V. (the “Company” and, together with its subsidiaries, “Curetis”), a developer of next-level molecular diagnostic solutions, today announced that its fully-owned subsidiary Ares Genetics has launched an early access program for its novel, artificial intelligence (AI) powered, next-generation sequencing (NGS) based molecular…

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OpGen Announces Stock Offering

GAITHERSBURG, Md., Oct. 23, 2019 (GLOBE NEWSWIRE) — OpGen, Inc. (Nasdaq:OPGN) today announced the pricing of an underwritten offering of an aggregate of 4,700,000 units at an effective price of $2.00 per unit. Each unit is comprised of one share of common stock (or common stock equivalent) and one common warrant to purchase one share…

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OpGen / Curetis Obtain U.S. Patent Covering Acuitas Lighthouse® Software

GAITHERSBURG, Md., Oct. 23, 2019 (GLOBE NEWSWIRE) — OpGen, Inc. (Nasdaq: OPGN) announced today that the United States Patent and Trademark Office (the “USPTO”) has allowed a key OpGen patent covering the Lighthouse Profiling technology used in the company’s software for tracking antimicrobial resistant pathogens. Patent application US 20160085912A1 “Systems, Apparatus, and Methods for Generating…

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Curetis Group Subsidiary Ares Genetics Signs R&D and Option Agreement with Leading Global IVD Corporation

Holzgerlingen, Germany, and Vienna, Austria, September 16, 2019, 08:00 am CET – Curetis N.V. (the “Company” and, together with its subsidiaries, “Curetis”), a developer of next-level molecular diagnostic solutions, today announced that its wholly-owned subsidiary Ares Genetics GmbH (“Ares Genetics”), Vienna, Austria, has entered into a multi-phase partnership with an undisclosed leading global in vitro…

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