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CareDx Receives CE Mark for AlloSeq cfDNA Kit

NEW YORK – CareDx said on Friday that it has received the CE mark for its AlloSeq cfDNA kit, making it available to transplant patients and clinicians in Europe.

AlloSeq cfDNA is a kit-based product that is used to quantify the level of donor-derived cell-free DNA in transplant recipients in order to measure graft health, and is run on next generation sequencing platforms. 

"AlloSeq cfDNA provides a measure of organ injury that can help monitor transplant patient outcomes. With the CE mark, we can begin our pan-European dd-cfDNA registry and studies with CareDx," Phil Mason, a transplant nephrologist at the NHS's Oxford University Hospitals, said in a statement.