In Vitro Diagnostics – IVD News

Curetis Publishes First Quarter 2016 Business and Financial Update – Worldwide commercial expansion and US FDA trial on track – Installed base of Unyvero Analyzers increased to 107 devices Amsterdam, the Netherlands and Holzgerlingen, Germany, May 20, 2016 — Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic…

-First and only blood-based colorectal cancer screening test approved by the FDA -Innovative, convenient and effective screening option for millions of eligible Americans -Commercialization initiated with partner Polymedco Berlin (Germany) and Germantown, MD (U.S.A.), April 13, 2016 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, today announced that the…

Curetis to Launch CE-IVD Unyvero Blood Culture Application Cartridge at ECCMID 2016 – Successful completion of CE Performance Evaluation Study – Covers 103 diagnostic targets with 87 pathogens and 16 resistance markers Amsterdam, the Netherlands and Holzgerlingen, Germany, March 23, 2016 — Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer of…

Curetis Validating Blood Culture Cartridge for CE-IVD Launch in Q2 Mar 03, 2016 NEW YORK (GenomeWeb) – In preparation for a CE-IVD launch in the second quarter, Curetis has initiated the final performance evaluation of its BCU Blood Culture Application cartridge to diagnose bloodstream infections. The Holzgerlingen, Germany-based company is also gathering momentum from its…

Curetis Starts Final Validation Study for New Unyvero Blood Culture Application Cartridge – Data and CE-IVD launch expected in Q2, 2016 – Company also prepares launch of 2nd generation ITI Application Cartridge and novel product for intra-abdominal infections Amsterdam, the Netherlands and Holzgerlingen, Germany, February 23, 2016 — Curetis N.V. (the “Company” and, together with…

Curetis Expands Commercial Team – Company hires Willem Haagmans as Head of Sales EMEA – Amsterdam, the Netherlands and Holzgerlingen, Germany, February 3, 2016 — Curetis N.V. (the “Company” and, together with Curetis AG, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced the expansion of its commercial and general administrative team. As of…

Curetis Establishes Medical Advisory Board with Internationally Renowned Experts Curetis AG, 11 Jan 16,  Amsterdam, The Netherlands, and Holzgerlingen, Germany, January 11, 2016 – Curetis N.V., a developer of next-level molecular diagnostic solutions for syndromic infectious disease testing, today announced the establishment of its Medical Advisory Board (MAB). Initially, it will consist of four leading experts…

Epigenomics Receives FDA Notification About Status of Pending Approval Decision for Epi proColon® Berlin, Germany, January 8, 2016 – Epigenomics AG, Berlin, Germany, (Frankfurt Prime Standard: ECX; ISIN: DE000A11QW50) the German-American cancer molecular diagnostics company, today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that the already submitted and available…

Curetis AG / Curetis IPO priced at EUR 10.00 per Share; raises EUR 40 million .  Holzgerlingen, Germany, November 10, 2015 — Curetis N.V.[1] (the “Company” and, together with Curetis AG, “Curetis“), a developer of next-level molecular diagnostic solutions, today announces the completion of its initial public offering, which was launched on October 28, 2015…