Diaxonhit Strengthens Its Offering in the Field of Quality Control for Clinical Laboratories

Regulatory News :

Diaxonhit (Paris:ALEHT) strengthens its offering in the field of quality control for clinical laboratories with the signing by InGen, its commercialization affiliate, of an exclusive agreement for France with CODASY, the Belgian specialist of software solutions for private and public clinical laboratories.

A growing demand for quality

With discussions continuing in the French Parliament, ongoing medical biology reform already requires all laboratories to operate under new regulatory requirements in terms of quality of performed tests. In particular, clinical laboratories must obtain ISO 15189 accreditation to operate with all qualifications required by the new quality standards.

Achieving and maintaining this certification require the daily use of independent quality controls to validate the results of laboratory tests performed in about 2 000 French clinical laboratories. Implementation of these controls is complex, and laboratories do not necessarily have the relevant expertise and means. Many institutions are looking for solutions that simplify implementation and management of quality controls, while limiting the number of required resources.

An integrated offering that meets the current needs of clinical laboratories

Diaxonhit already offers a range of quality control tests and reagents to clinical laboratories in France by marketing partner products in the field of viral and bacterial infections, Immunoassay, toxicology and emergency tests.

With this new exclusive partnership with CODASY for the implementation of the QC Connect software, Diaxonhit now has an integrated offering for implementation and management of quality, which targets specifically clinical laboratories. QC Connect enables the integrated daily tracking of quality checks performed on analyzers to measure deviations from expected standards, to alert operators in case of failure and to provide regulatory documentation related to controls and monitoring. With the integration of the new software to its range of quality control tests, Diaxonhit enables laboratories to more easily meet the requirements of their ISO-15189 qualification while providing one-stop shopping for quality controls.

A growing business

Diaxonhit sales in the field of quality control, which represented 4% of its total product sales, increased by more than 14% in 2012. The first half of 2013 confirms this trend with an increase of 17% compared to the first half of 2012. With this new integrated offering Diaxonhit provides a better response to the needs of its customers, and intends to accelerate its penetration in this very promising market.

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: immuno-infection, Alzheimer's disease 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

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