In Vitro Diagnostics – IVD News

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…

Berlin (Germany), June 17, 2019 – Epigenomics AG (FSE: ECX, OTCQX: EPGNY; the “Company”), a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology, today reported new study results suggesting that Epi proColon, a colorectal cancer screening test approved for patients who are unwilling or unable to be…

Amsterdam, the Netherlands, San Diego, CA, USA, and Holzgerlingen, Germany, June 04, 2019 – Curetis N.V. (the “Company” and, together with Curetis GmbH and Curetis USA Inc. “Curetis”), a developer of next-level molecular diagnostic solutions, today announced that new data on its Unyvero System and LRT Application Cartridge for pneumonia will be presented at the…

Amsterdam, the Netherlands, and Holzgerlingen, Germany, May 23, 2019 — Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis”), a developer of next-level molecular diagnostic solutions, today announced key data from its successfully completed Unyvero LRT clinical performance evaluation study for BAL samples. The study was designed based on U.S. FDA feedback to demonstrate enhanced…

Berlin (Germany) and San Diego, CA (U.S.A.), May 20, 2019 – Epigenomics AG (FSE: ECX, OTCQX: EPGNY; the “Company”), a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology, today reported new results that underscore Epi proColon(R) colorectal cancer’s (CRC) high acceptance rate compared with stool-based screening tests…

Growing body of evidence shows benefits of Unyvero for antibiotic stewardship 8 new reports on European studies presented by clinical researchers using Unyvero HPN, ITI, BCU and IAI Amsterdam, the Netherlands; San Diego, CA, USA; and Holzgerlingen, Germany; April 04, 2019, 08:00 am CET — Curetis N.V. (the “Company” and, together with Curetis USA Inc.…