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13.01.2014 17:40:00

Diaxonhit Enters into a Distribution Agreement with SAMSUNG " Health Medical Equipment " Division for Commercialization of Point of Care Diagnostic Tests

Regulatory News :

Diaxonhit (Paris:ALEHT) strengthens its offering in the field of immunoassay and point of care ("POC”) tests for public and private clinical laboratories as well as emergency services with the signing by InGen, its commercialization affiliate, of a distribution agreement with South Korean Samsung Group (In Vitro Diagnostic Department of Samsung Electronics France). The agreement covers the marketing of IB10, PT10 and HC10 equipment together with associated reagents, in France and its overseas territories.

Diaxonhit is already active in the field of immunoassays and in emergency units with its proprietary Tetanus Quick Stick test ("TQS®"), and through the distribution of Quidel Corporation’s SOFIA systems. With this new agreement, the Group will offer to 800 hospital laboratories and 600 emergency services, three new innovative POC diagnostic instruments. These automates and related reagents cover cardiac markers (IB10), biochemistry (PT10) and blood counts (HC10).

New generation equipment

With these instruments and associated reagents, grouped within the LABGEO product line, it is possible to obtain faster analytical results from a simple blood sample mixed with an anticoagulant (heparinized whole blood) in a centrifugation-free process. The IB10 and PT10 operate using all-in-one disposables. They help ensure optimal traceability of all performed tests and can manage directly up to 5000 patient records.

This product line benefited from SAMSUNG’s know-how in consumer electronics. The units include a touch screen with an intuitive interface. They also provide several interfaces for external connection, either through wired networks (3 different protocols for connection to central IT systems) or via the LABGEO Mobile application that can send encrypted text messages compatible with the GALAXY line of tablets and smartphones.

This range of instruments and reagents are CE-IVD marked, and can be included in an ISO 22870 quality system (POC analyses standard).

During the JIB ("Journées Internationales de Biologie”) held in Paris in November 2013 , SAMSUNG received the "Emergency and POC biology" award with the IB10 instrument for measuring one or several cardiac biomarkers in an emergency environment (troponin, Nt-proBNP, D-dimer).

A particularly attractive offer for cardiac emergencies

With the IB10 offer, Diaxonhit is now positioned in the growing market of early diagnosis of heart attacks. The latest generation features and the small size of this equipment make it particularly suitable for mobile use in emergency vehicles where the physician will be able to perform an earlier diagnosis and immediately select the best treatment option, thus increasing chances of survival.

In the context of myocardial infarction, it was found that mortality could be reduced by 50% with a relevant treatment carried out during the first hour after onset of chest pain, and 30% during the second hour (1). Also, given the unavoidable delays in patient admissions, it was also observed that administration of treatments prior to arrival at the hospital, reduces mortality by approximately 15% (1). These observations justify the critical utility of an early diagnosis made possible by carrying IB10 equipment on board emergency vehicles.

In France, coronary heart disease is the second leading cause of mortality with approximately 100,000 myocardial infarctions and 46,000 deaths per year (2). The cardiac activity alone represents an average of 20-40% of the activity of emergency mobile units (3).

Building on the emergency market

In close collaboration with SAMSUNG’s teams, Diaxonhit brings to this partnership its expertise in immunoassays and its recognized knowledge of emergency units. This agreement allows both companies to offer personalized next-generation solutions, better responding to current developments in the field of medical biology. With a prestigious partner, Diaxonhit strengthens its offer in the field of emergency where medical needs are increasing regularly.

1. (1) Source: Acute coronary syndrome within the prehospital P. Goldstein et al , regional Samu Lille .
2. (2) Source: Health Authority
3. (3) Sources: Regional SMUR

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About Diaxonhit

Diaxonhit (NYSE Alternext, FR0004054427, ALEHT) is a French fully integrated leader in the in-vitro diagnostic field, involved from research to commercialization of specialty diagnostic products.

With many partnerships and a strong presence in hospitals, Diaxonhit has an extensive commercialization network. Through its affiliate, InGen, it commercializes and services, mostly under exclusivity agreements, in-vitro diagnostic kits and advanced equipment. It operates mainly in the fields of transplantation, infectious diseases and autoimmunity, product quality control and rapid tests, including Tetanus Quick Stick ®, a proprietary product. InGen is the leading supplier in France of HLA tests manufactured by Thermo-Fisher/One Lambda, of which it is the largest distributor worldwide.

The group also owns a diversified portfolio of products in development, including both innovative molecular and non-molecular diagnostics, covering three main specialty areas: transplantation, immuno-infection and cancer.

Diaxonhit headquarters are located in Paris and its affiliate in the Paris region. The Group is listed on NYSE Alternext in Paris and is part of the NYSE Alternext OSEO innovation index.

For more information, please visit: http://www.diaxonhit.com.

Disclaimer

This press release contains elements that are not historical facts including, without limitation, certain statements about future expectations and other forward-looking statements. Such statements are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those anticipated.

In addition, Diaxonhit, its shareholders, and its affiliates, directors, officers, advisors and employees have not verified the accuracy of, and make no representations or warranties in relation to, statistical data or predictions contained in this press release that were taken or derived from third party sources or industry publications, and such statistical data and predictions are used in this press release for information purposes only.

Finally, this press release may be drafted in the French and English languages. In an event of differences between the texts, the French language version shall prevail.

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