NEW YORK – CareDx announced on Tuesday that it has received CE marking for the AlloSeq HCT chimerism testing kit and AlloSeq HCT interpretation software, both used in patients who have undergone hematopoietic cell transplantation.
The next-generation sequencing-based test measures the relative ratio of recipient-to-donor cell populations post-transplantation, targeting 202 bi-allelic single-nucleotide polymorphisms across 22 autosomes.
"This new CE mark demonstrates our commitment to bringing high quality products to patients in Europe through our AlloSeq franchise, which includes a comprehensive suite of pre- and post-transplant solutions," Reg Seeto, CEO and president of CareDx, said in a statement.
AlloSeq HCT is part of the firm's wider expansion from organ monitoring into cell transplant monitoring. The company launched AlloCell, a surveillance tool for patients receiving engineered cell transplants, in 2020, and presented data on both that product and AlloSeq HCT at the Transplantation and Cell Therapy conference last year.
Last year, CareDx also acquired European software firm BFS Molecular, a company dedicated to tracking transplanted organ and stem cell health via next-generation sequencing.