In Vitro Diagnostics – IVD News

Amsterdam, the Netherlands, and Holzgerlingen, Germany, January 30, 2019; published at 08:00 a.m. CET — Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis”), a developer of next-level molecular diagnostic solutions, today announced that its partner for the commercialization of Unyvero in the ASEAN region, Acumen Research Laboratories Pte Ltd. (Acumen), has received first…

Ares Genetics to start EUR 1.3 million TRIPLE-A development project co-funded by Vienna Business Agency Initiates set-up of R&D and service laboratory in Vienna Vienna, Austria, Holzgerlingen, Germany, and Amsterdam, The Netherlands; January 08, 2019; published at 08:00 am CET – Curetis N.V. (the “Company” and, together with its subsidiaries, “Curetis”), a developer of next-level…

> Strategic collaboration agreement with Sandoz to develop digital anti-infectives platform > Collaboration leverages Ares Genetics’ antibiotic resistance database ARESdb > Short-term focus on repurposing existing antibiotics to treat infections with multi drug resistant pathogens Vienna, Austria, Holzgerlingen, Germany and Amsterdam, The Netherlands; December 18, 2018; published at 08:00 am CET – Curetis N.V. (the…

NEW YORK (GenomeWeb) – Curetis announced today that it has extended an exclusive distribution agreement with Beijing Clear Biotech (BCB), expanding it from five years to eight years following the first Chinese regulatory approval. The strategic collaboration covers distribution of the Curetis Unyvero A50 platform and assay cartridges in China. The amendment to the original…

ARESupa test aims at broad detection of microbial infections employing next-generation sequencing and artificial intelligence Curetis explores venture capital (VC) funding for Ares Genetics while assessing all strategic and tactical financing options for growth of Unyvero core business Amsterdam, the Netherlands, Holzgerlingen, Germany, and Vienna, Austria, September 04, 2018, 01:00 am EST – Curetis N.V.…

Aug 08, 2018  NEW YORK (GenomeWeb) — Epigenomics reported today an 88 percent year-over-year increase in second quarter revenues amid strong growth in product sales and higher licensing income. For the three-month period ended June 30, Epigenomics’ revenues rose to €462,000 ($535,912) from €246,000 in the same period last year. Product sales — which include…

– Epigenomics plans to CE Mark mSEPT9 blood test for liver cancer by year-end 2018, enabling commercialization in Europe – Prospective U.S. trial for FDA submission to be initiated in 2019 – Investigating optimal path for CFDA approval in China Berlin (Germany) and San Diego, CA (U.S.A.), July 2, 2018 – Epigenomics AG (FSE: ECX,…

UTI panel covers 103 diagnostic targets 443-patient multi-center study demonstrates overall weighted average sensitivity of 95.6% at an overall weighted average specificity of 99.3%.  Amsterdam, the Netherlands; San Diego, CA, USA; and Holzgerlingen, Germany; April 19, 2018, 01:00 EDT — Curetis N.V. (the “Company” and, together with Curetis USA Inc. and Curetis GmbH, “Curetis“), a developer of next-level…

– First ever multiplex MDx test to be granted clearance by the FDA for this indication – Commercial launch in the U.S. expected this quarter Amsterdam, the Netherlands, San Diego, CA, USA, and Holzgerlingen, Germany, April 03, 2018, 15:45 am EDT – Curetis N.V. (the “Company” and, together with Curetis USA Inc. and Curetis GmbH,…

– Second market authorization for Unyvero Cartridges this year in Singapore Amsterdam, the Netherlands, and Holzgerlingen, Germany, April 04, 2018; published at 11:30 am CEST — Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis”), a developer of next-level molecular diagnostic solutions, today announced that Acumen Research Laboratories Pte. Ltd. (Acumen), its partner for…