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AlloMap™ molecular expression testing

Products Next higher product group real-time PCR test (clinical diagnostics)
Period Status 2005-05-02 sales existent
     

Diaxonhit S.A.. (1/12/15). "Press Release: Diaxonhit Announces that Strasbourg University Hospital Will Become its European Central Laboratory for Processing the CareDx AlloMap Heart Transplant Tests". Paris.

> A major step for AlloMap implementation in Europe

> Strasbourg is a laboratory with renown expertise in transplantation

> This lab will provide central position in Europe facilitating sample logistics


DIAXONHIT (Alternext : ALEHT, FR0004054427), a French leader in specialty in-vitro diagnostics for transplantation, infectious diseases and cancer, announced today that it entered into a service sub-licensing agreement with the Strasbourg University Hospitals (Hôpitaux Universitaires de Strasbourg, HUS) for the performance of the CareDx, Inc. (Nasdaq: CDNA) AlloMap® test in a dedicated facility as its Central European Laboratory. Under this agreement, all testing activities will be performed in HUS’ Central Immunology Laboratory, under the authority and exclusive responsibility of HUS and its scientific director, Professor Seiamak Bahram.

The AlloMap molecular blood test is a novel method for regular and non-invasive surveillance of heart transplant recipients for acute cellular rejection. All patients’ blood samples collected in heart transplant centers around Europe will be shipped to the Strasbourg facility where the AlloMap testing procedure will be performed. Test results will be sent back directly from the Central Laboratory to the clinicians, consisting primarily of cardiologists and heart surgeons.

DIAXONHIT is the exclusive European distributor of the AlloMap test. It will supply the central laboratory with specific AlloMap plates and control reagents both manufactured by CareDx, the developer and licensor of AlloMap. DIAXONHIT will also supply heart transplant centers with a kit to facilitate blood samples handling and shipment.

HUS’ Central Immunology Laboratory was selected by DIAXONHIT for its ability to conduct the testing procedure with all necessary quality requirements to ensure the accuracy and reproducibility of AlloMap results delivered to prescribing clinicians. Under the leadership of Professor Seiamak Bahram who is also director of TRANSPLANTEX, a French government funded “Laboratory of Excellence” (LabEx), this laboratory is at the forefront in the fields of transplantation and histocompatibility in Europe. A dedicated team of seasoned technical staff and biologists will perform the AlloMap procedure within a well-defined environment, including specific instruments that are currently being implemented. Staff training will be initiated soon by DIAXONHIT and CareDx in order for the laboratory to become operational during the first half of 2015.

The HUS location in Strasbourg is also a key advantage. Centrally positioned between southern and northern Europe on the French-German border, this location will facilitate rapid handling of blood samples from any European country and ensure more efficient delivery from heart transplant centers.

“We are extremely pleased that our laboratory was selected for becoming the European central site for performing the AlloMap test. After the US, this will allow French and European heart transplanted patients to have access to this state-of-the-art, non-invasive test. We are eager to start working with DIAXONHIT and CareDx as well as the various European transplant teams in order to offer the test as soon as possible.” said Professor Seiamak Bahram, Head of HUS’ Central Immunology Laboratory.

According to Peter Maag, CEO of CareDx: “We are pleased and excited to have HUS as the European laboratory partner to perform AlloMap. Their world-class experience and expertise with molecular diagnostics and transplant care make them well-suited to perform this non-invasive test that will positively impact care among European heart transplant recipients. ”

“With the selection of the Strasbourg University Hospitals, a prestigious institution, another key milestone was reached for DIAXONHIT, as it will facilitate AlloMap’s implementation in Europe. We were impressed by the enthusiasm and dedication of the HUS staff, and feel that AlloMap testing will be performed by the best possible team.” concludes Dr. Loïc Maurel, President of the Management Board of Diaxonhit.


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About AlloMap®

AlloMap Molecular Testing is intended to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection (ACR) at the time of testing in conjunction with standard clinical assessment. AlloMap is performed in the CLIA-certified and CAP-accredited clinical laboratory at CareDx and has been commercially available in the United States since 2005. AlloMap was cleared by the U.S. Food and Drug Administration in 2008 and was CE marked for the European Union in 2011. Recommended use of AlloMap for heart transplant rejection surveillance is included in the International Society for Heart and Lung Transplantation (ISHLT) Guidelines for the care of heart transplant recipients, published in August, 2010. These guidelines represent the worldwide standard for the care of heart transplant patients.


About CareDx

CareDx, Inc., based in Brisbane, California, is a molecular diagnostics company focused on the discovery, development, and commercialization of clinically differentiated, high-value, non-invasive diagnostic surveillance solutions for transplant recipients. The company has commercialized AlloMap, a gene expression test that aids clinicians in identifying heart transplant recipients with stable graft function.
For more information, please visit: www.CareDxInc.com.


About DIAXONHIT

Diaxonhit (NYSE Alternext, FR0004054427, ALEHT) is a French fully integrated leader in in vitro diagnostics, involved from research to commercialization of specialty diagnostic products in the fields of transplantation, infectious diseases and cancer. 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, quality control products 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 commercial partner worldwide. The group also owns a diversified portfolio of products in development, including both innovative molecular and non-molecular diagnostics, covering its 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 both the NYSE Alternext OSEO Innovation and the Next Biotech indices. For more information, please visit: http://www.diaxonhit.com

Symbol : ALEHT - ISIN Code: FR0004054427 - Reuters : ALEHT.PA - Bloomberg : ALEHT:FP


Contacts

DIAXONHIT
Hervé Duchesne de Lamotte, CFO, +33 (0)1 53 94 52 49, herve.delamotte@diaxonhit.com

CareDx, Inc.
Bradley P. Sherrill, Senior Director, Marketing, +1 415-287-2397, bsherrill@caredxInc.com

NewCap
Julien Perez, Investors Relations & Financial Communication, +33 (0)1 44 71 98 52, jperez@newcap.fr
Annie-Florence Loyer, Media Relations, +33 (0)1 44 71 98 50, afloyer@newcap.fr


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. If both versions are interpreted differently, the French language version shall prevail.

   
Record changed: 2016-05-29

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