30 January 2018
GenDx is the first global company to register a chimerism monitoring product line as CE-IVD. The chimerism portfolio is intended for monitoring the chimeric status after a stem cell or bone marrow transplantation and includes KMRtype® and KMRtrack® reagents, as well as KMRengine® software.
The in vitro diagnostic products will be distributed to clinical laboratories, supporting transplant centers worldwide to accurately monitor the chimeric status of transplant recipients.
The products are based on real-time PCR, which makes them 10-50 fold more sensitive than the widely used short tandem repeats (STR) detection strategy. Therefore, relapses can be detected significantly earlier compared to the STR method, which enables earlier treatment decisions.
Dr. Wietse Mulder, CEO of GenDx, commented: “We have worked really hard to improve and validate our real-time PCR reagents and software package and are thrilled that we have realized the design goals and the CE-IVD registration. This set of diagnostic tools advances accurate chimerism monitoring of transplant patients and supports timely intervention when needed. This accomplishment strengthens our pioneer status in the field of transplantation diagnostics and establishes GenDx as the global leader of chimerism monitoring solutions using real-time PCR.”
Readers of this message, who are interested in Chimerism monitoring product line and wonder whether they could benefit from this registration, can receive more information by contacting their local GenDx distributor or contacting GenDx directly.