CareDx Inc. and Diaxonhit 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. 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.