In Vitro Diagnostics – IVD News

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…

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…

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…

Gaithersburg, MD, USA, Amsterdam, the Netherlands, and Holzgerlingen, Germany, 04 September 2019, 0800 am CET, 0655 am ET  – OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease, and Curetis N.V. (Euronext: CURE, “Curetis”), a developer of next-level molecular diagnostic solutions, today…

Curetis Files for U.S. FDA 510(k) Clearance of Unyvero LRT for BAL Specimens Final LRT BAL panel demonstrates overall weighted average sensitivity of up to 94.7% and overall weighted average specificity of up to 98.4% Unyvero provides results after approximately five hours, compared to an average of several days for standard-of-care methods Amsterdam, the Netherlands,…

BERLIN and SAN DIEGO, (GLOBE NEWSWIRE) — Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY) announced today that it was selected by MedTech Outlook to receive the 2019 Top 10 In-Vitro Diagnostics Award. Conducted annually, the award recognizes companies that are excelling in their respective fields. The selection panel noted that through its unique, proprietary DNA methylation…