BRISBANE, Calif. and PARIS, Jan. 12, 2016 (GLOBE NEWSWIRE) -- CareDx, Inc. (Nasdaq:CDNA), a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic surveillance solutions for transplant patients, and Diaxonhit (Alternext:ALEHT) (FR0004054427), a French leader in specialty in-vitro diagnostics for transplantation, infectious diseases and cancer, have announced the completion of the transfer of the CareDx proprietary AlloMap gene expression test into the Strasbourg University Hospital Central Immunology Laboratory (HUS) in France. This rigorous, multi-step validation process has demonstrated that AlloMap test results released from the HUS laboratory are equivalent to AlloMap results generated by the CareDx main laboratory in the United States. With the completion of this technology transfer, patient samples can now be tested at HUS.
This transfer is a significant milestone for CareDx and its exclusive European licensee and commercial partner, Diaxonhit, which contracted with Strasbourg University Hospital in 2014 to be the dedicated testing laboratory for AlloMap throughout Europe. This technology transfer is the first of its kind, and was completed through a strong collaboration among commercial, technical and development teams at CareDx, Diaxonhit and HUS.
“My staff and I are very pleased with the completion of this technology transfer,” says Professor Seiamak Bahram, Director of the HUS Central Immunology Laboratory and the National Laboratory of Excellence (LabEx) Transplantex. “Gene expression profiling can be complex. Our state-of-the art facilities and expert staff will ensure that AlloMap testing is conducted with the highest level of quality and reliability.” HUS CEO Christophe Gautier stated: “We at HUS are extremely pleased that our hospital in Strasbourg has become the single testing location for AlloMap in Europe.”
Diaxonhit has utilized its expertise in transplantation to design health economic studies for AlloMap reimbursement in Europe. The French Ministry of Health has recently approved the funding of a study designed to demonstrate that AlloMap is non-inferior to biopsy to inform about the risk of acute cellular rejection among French heart transplant patients.
Loic Maurel, the Management Board President at Diaxonhit, stated: “I want to thank the teams at CareDx and HUS who managed to successfully finalize this technology transfer. Following Diaxonhit’s commitment to Allomap and substantial investment, we are quite pleased to have this test available to European patients, particularly in France where clinicians and health authorities have expressed a strong interest.”
Peter Maag, President and CEO of CareDx, concluded: “The technology transfer of AlloMap demonstrates that CareDx is committed to providing AlloMap to heart transplant patients regardless of location. This unique partnership with both a prestigious university based laboratory and a strong commercial organization will increase the availability of AlloMap for transplant patients in Europe.”
CareDx, Inc., based in Brisbane, California, is a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic surveillance solutions for transplant patients. The company has commercialized AlloMap®, a gene expression test that aids clinicians in identifying heart transplant patients with stable graft function who have a low probability of moderate/severe acute cellular rejection. CareDx is also pursuing the development of additional products for transplant monitoring using a variety of technologies, including AlloSure™, its next-generation sequencing–based test to detect donor-derived cell-free DNA after transplantation. For more information, please visit: www.CareDx.com.
DIAXONHIT 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. It is the leader for commercialization in France of HLA tests. With many partnerships and a strong presence in hospitals, Diaxonhit has an extensive commercialization network and a portfolio of proprietary products including Tetanus Quick Stick® and BJI Inoplex® in the field of infectious diseases. Each year, the Group invests in R&D more than 15% of its sales to develop new, innovative and proprietary diagnostic tests. Diaxonhit has 85 employees based in Paris and the Paris region. The Group is part of the Alternext BPI Innovation, PEA-PME 150 and Next Biotech indices. For more information, please visit: www.diaxonhit.com.
Forward Looking Statements
This press release contains forward-looking statements including, but not limited to statements regarding the Company's expectations regarding future potential, development and commercial activities. 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.
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