BRISBANE, Calif., Jan. 12, 2015 (GLOBE NEWSWIRE) -- CareDx, Inc. (Nasdaq:CDNA), a molecular diagnostics company focused on the development and commercialization of clinically differentiated, high value, non‐invasive surveillance solutions for transplant recipients, today announced that its exclusive commercial partner in Europe, Diaxonhit (Alternext: ALEHT, FR0004054427), a French leader in specialty in-vitro diagnostics for transplantation, infectious diseases and cancer, has entered into an agreement with the Strasbourg University Hospital (HUS) to be Diaxonhit's dedicated laboratory for AlloMap testing in Europe. Under this agreement, all testing activities for Europe will be performed in the HUS Central Immunology Laboratory, under the authority and exclusive responsibility of HUS and its scientific director, Professor Seiamak Bahram. A dedicated team of seasoned technical staff and biologists will perform AlloMap within a well-defined environment, using dedicated 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 2015.
The agreement with HUS is a significant step towards providing European heart transplant recipients and their caregivers with AlloMap as part of their overall post-transplant surveillance and care. In parallel, Diaxonhit is working with individual European country health authorities to develop additional health economic data that may be required to obtain reimbursement coverage for AlloMap.
"With the selection of the Strasbourg University Hospitals, a prestigious institution, we have achieved another key milestone 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," stated Dr. Loïc Maurel, President of the Management Board of Diaxonhit.
According to Peter Maag, President and CEO of CareDx, "We are pleased and excited to have HUS as the European laboratory partner to perform AlloMap testing. 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."
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 who have a low probability of moderate/severe acute cellular rejection. 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
Forward Looking Statements
This press release contains forward-looking statements including, but not limited to, statements regarding the operability of the new laboratory facility, our relationship with laboratory service providers, anticipated growth of the use of AlloMap, our ability to obtain reimbursement for AlloMap tests, and international expansion of our business. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward looking statements, including CareDx's limited operating history and experience with developing new markets; risk relating to new partnerships and commercialization of those relationships, as well as other risks stated in CareDx's filings with the SEC located at www.sec.gov. CareDx disclaims any obligation to publicly update or revise any forward looking statements to reflect events that occur or circumstances that exist after the date on which they were made.