In Vitro Diagnostics – IVD News

Berlin, 28.02.2020– Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”) announces that the Centers for Medicare & Medicaid Services (CMS) have opened the National Coverage Determination (NCD) review of Epi proColon, Epigenomics’ blood test for colorectal cancer screening. This means that according to the statutes, a decision on CMS’s reimbursement of Epi proColon…

Vienna, Austria, Holzgerlingen, Germany, and Shenzhen, China, January 30, 2020, 08:00 am CET – Ares Genetics GmbH, a Curetis Group company, and the Chinese genomics company BGI Group today announced that the companies will collaborate in making molecular testing for the new coronavirus 2019-nCoV available in Europe. 2019-nCoV is a new coronavirus variant that has…

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)…

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…

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…

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…

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…

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…

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…

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…