Press Release: Mobidiag Announces CE-IVD Marking of Amplidiag™ Bacterial GE for Fast and Accurate PCR-Based Diagnostics of Gastroenteritis

Test optimizes screening of gastroenteritis-causing bacteria directly from stool samples

Espoo, Finland – Sept. 23, 2014 – Mobidiag Ltd, a Finnish molecular diagnostics company specialized in the development of innovative diagnostics solutions for infectious diseases, today announced the European launch of Amplidiag™ Bacterial GE, marketed as a CE-IVD product under the Directive 98/79/EC on in vitro diagnostic medical devices. CE marking follows the successful completion of a two-center performance evaluation study. The test optimizes stool sample screening processes by utilizing well-established qPCR technology for rapid qualitative detection of eight gastroenteritis-causing bacteria. In contrast to current routine practices, the test does not require pre-culturing of the sample, bringing both laboratory process benefits by substantially reduced need for cultures, as well as clinical benefits by providing early, clinically relevant information. The test’s rapid and comprehensive results enable timely, evidence-based patient management decisions, contributing to improved healthcare processes.

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Press Release: Mobidiag, Genewave, and Amplidiag Announce Merger to Create a Leading Innovator in Molecular Diagnostics

MERGER ANNOUNCEMENT
Helsinki, Finland and Paris, France  –  April 12, 2013

Mobidiag, Genewave, and Amplidiag announce merger to create a leading innovator in molecular diagnostics

– The new Mobidiag to offer integrated, high-multiplex diagnostic tests for infectious diseases

Mobidiag Oy/Ltd, Genewave SAS, and Amplidiag Oy today announced a definitive agreement to combine the three companies to create a technology leader in molecular diagnostics for infectious diseases. The new Mobidiag combines Mobidiag’s and Amplidiag’s high-multiplex proprietary diagnostic test portfolios with Genewave’s automated and integrated test platform. The merger was accompanied by a financing round by existing investors Helsinki University Fund, iXLife, Tutor Invest (Medtech Rahasto Ky), and others, as well as public funding support from the Finnish funding agencies, Tekes and Finnvera, and the EU. Joining as Mobidiag’s new CEO is Tuomas Tenkanen, the former R&D Director of the diagnostics PCR products provider, Finnzymes Oy, which was acquired by Thermo Fisher Scientific.

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