Mobidiag Announces Release of Amplidiag^® Stool Parasites (CE-IVD), a Multiplex PCR Test to Detect Parasites Directly from Stool Samples

ESPOO, Finland, August 29^th, 2016 – Mobidiag Ltd, a Finnish molecular diagnostics company, today announced the launch of its CE-IVD marked Amplidiag^® Stool Parasites kit, a molecular test allowing detection of the main diarrhea causing stool parasites: Giardia lamblia, Cryptosporidium spp., Entamoeba histolytica and Dientamoeba fragilis.

Pathogenic protozoa are the main causative agents of parasite-associated gastroenteritis due to their ability to multiply in humans. If not detected and treated in time, they can cause diarrhea and a wide variety of other prolonged symptoms, such as colitis, abdominal discomfort, and nausea, symptoms that compromise quality of human life. As a result, infections caused by stool parasites raise important public health challenges with a strong economic impact globally.

PRESS RELEASE

Mobidiag Secures 15 Million Euros from EIB to Accelerate the Launch of its Novodiag^® Platform and Suite of In Vitro Diagnostic Tests

PORI, Finland, July 14th, 2016 – Mobidiag Oy, a Finnish molecular diagnostics company, today announced that it has signed a 15 million euro loan with the European Investment Bank Group. As part of the InnovFin initiative, the loan will allow Mobidiag to finalize and scale up Novodiag^®products manufacturing, assay validation and commercialization over the next 3 years. The operation is supported by ‘InnovFin – EU Finance for Innovators’, with the financial backing of the European Union under Horizon 2020 Financial Instruments.

Raising accessibility to Amplidiag^® gastrointestinal diagnostics tests in Europe

ESPOO, Finland, June 23, 2016 – Mobidiag Ltd, a Finnish molecular diagnostics company, today announced an agreement with Isogen Life Science, provider of instruments, reagents and consumables for the life sciences market, for the distribution of the Amplidiag^® product line. Under this new agreement Isogen becomes the exclusive distributor of Amplidiag^®, in vitro diagnostics for gastrointestinal infections, in Belgium, the Netherlands, Luxembourg and Spain.

Mobidiag’s CEO Tuomas Tenkanen was invited this morning to major Finnish television channel MTV3, along with expert Jaana Vuopio (Professor, University of Turku), to talk about the global threat of resistant super bacteria. These bacteria are very difficult to detect and treat, and can often lead to serious infections. For the past years, new technologies have been introduced to diagnose these bacteria as early as possible but they were shown to be either too expensive or unadapted to routine diagnostics.

The agreement solidifies Unilabs’ position as an industry-leading diagnostics service provider and is a major milestone for Mobidiag in European market entry

Espoo, Finland, and Göteborg, Sweden – September 1, 2015 – Mobidiag Ltd, a Finnish molecular diagnostics company specialized in the development of innovative diagnostics solutions for infectious diseases, and Unilabs, an industry-leading diagnostics service provider, today announced an agreement covering the supply of Amplidiag products over the next four years for Unilabs in Sweden and Norway.

Test is first-to-market, non-invasive IVD assay for reliable detection of both Helicobacter pylori and clarithromycin resistance from stool sample

Espoo, Finland – June 3, 2015 – Mobidiag Ltd, a Finnish molecular diagnostics company specialized in the development of innovative diagnostics solutions for infectious diseases, today announced the CE-IVD marking of Amplidiag™ H. pylori+ClariR. The qualitative qPCR-based test expands the gastrointestinal Amplidiag test menu and is immediately available throughout Europe. The first-to-market, non-invasive molecular diagnostic test reliably detects the gastric pathogen H. pylori as well as one of its key resistances to clarithromycin. The test is performed directly from stool DNA extract in a rapid manner.

Novodiag™ and Amplidiag™ Easy platforms to serve both low- and high-throughput customer needs with emphasis on accessibility and affordability

Espoo, Finland – April 22, 2015 – Mobidiag Ltd, a Finnish molecular diagnostics company specializing in the development of innovative diagnostics solutions for infectious diseases, today announced the first public presentation of two new diagnostic platforms – Novodiag and Amplidiag Easy – at ECCMID 2015 in Copenhagen on April 25-28.

The entirely new Novodiag platform is a fully integrated and automated system, enabling accessible and affordable molecular testing. The platform enables fast, very easy to use and highly multiplexed on-demand molecular testing for any throughput needs. It combines advanced features, ease of use, and affordability unmatched by currently available products, and requires no dedicated molecular testing expertise. The Novodiag platform will be readied for a full commercial launch in mid-2016 to serve various testing needs in the infectious diseases space, as well as in other potential markets which are unserved by current molecular platforms.

Test offers high sensitivity and specificity for pathogenic C. difficile and highly accurate differentiation of the hypervirulence-associated 027 ribotype

Espoo, Finland – April 8, 2015 – Mobidiag Ltd, a Finnish molecular diagnostics company specialized in the development of innovative diagnostics solutions for infectious diseases, today announced the launch of Amplidiag™ C. difficile+027, a qualitative qPCR-based test performed from DNA extracted from stool in suspected cases of C. difficile infection (CDI). The test is now CE-IVD marked and immediately available throughout Europe. The test is both economical and well suited for high-volume screening purposes. It offers both accurate detection of pathogenic C. difficile by detection of tcdB (toxin B) gene, and highly accurate differentiation of the hypervirulence-associated 027 ribotype, in a single reaction.

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.

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.