CE mark approval enables global availability of dd-cfDNA measurement for monitoring transplant health
South San Francisco, CA (GLOBE NEWSWIRE) - CareDx, Inc. (Nasdaq: CDNA), a leading precision medicine company focused on the discovery, development and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, announced that it has received CE mark approval for its AlloSeq cfDNA kit, making it broadly available to transplant patients and clinicians.
AlloSeq cfDNA is an innovative kit based solution, run on next generation sequencing (NGS) platforms, that enables measurement of dd-cfDNA in labs outside of the US. CareDx launched AlloSeq cfDNA during the European Society for Organ Transplantation (ESOT) Congress.
“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,” said Dr. Phil Mason, Transplant Nephrologist, Oxford.
“Implementing AlloSeq cfDNA in my laboratory was easy, and with minimum training my staff was able to precisely measuring donor-derived cfDNA in our transplant recipient samples,” said Jean Villard, MD, PhD, Geneva University Hospital.
“Transplantation is global, and CareDx is committed to providing best-in-class solutions for all transplant patients,” said Peter Maag, CEO at CareDx. “We are excited to announce this milestone of broad commercialization of AlloSeq cfDNA.”
CareDx, Inc., headquartered in Brisbane, California, is a leading precision medicine solutions company focused on the discovery, development and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers products, testing services and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients.
For more information, please visit: www.CareDx.com.
© 2020 GlobeNewswire, Inc. All Rights Reserved.