In Vitro Diagnostics – IVD News

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.…

NEW YORK (GenomeWeb) Mar 26, 2019 – Vela Diagnostics has submitted a next-generation sequencing (NGS) assay that detects HIV-1 drug resistance mutations (DRMs) to the US Food and Drug Administration (FDA), the company announced today. The Sentosa SQ HIV Genotyping Assay can be used on plasma samples from patients with HIV-1 infection to detect HIV-1…

Menarini Diagnostics to distribute Unyvero Platform and application cartridges in numerous European countries Menarini Diagnostics to deploy its commercial team for the marketing of Unyvero Platform across Europe Partnership to be launched at ECCMID 2019 in Amsterdam Amsterdam, the Netherlands, and Holzgerlingen, Germany, March 26, 2019, 08:00 am CET – Curetis N.V. (the “Company” and,…

Berlin (Germany) and San Diego, CA (U.S.A.), March 15, 2019 – Representatives Donald Payne, Jr. (D-NJ) and Kenny Marchant (R-TX) today introduced the ”Donald Payne Sr. Colorectal Cancer Detection Act” to the United States House of Representatives in Washington D.C. This House Bill aims to provide payment and coverage under the Medicare program for FDA-approved…

February 18, 2019, 22:00 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 (Vienna, Austria) and QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) have entered into a strategic licensing agreement for ARESdb and AREStools in…

Amsterdam, the Netherlands, and Holzgerlingen, Germany, February 04, 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 Beijing Clear Biotech (BCB) has filed for regulatory approval of the Unyvero A50 HPN Application Cartridge for pneumonia with the Chinese National…