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CareDx Receives CE Mark for AlloSeq HCT for Use in Hematopoietic Cell Transplantation | ||
By: GlobeNewswire - 24 May 2022 | Back to overview list |
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CareDx Expands Transplant Portfolio in Europe SOUTH SAN FRANCISCO, Calif., May 24, 2022 (GLOBE NEWSWIRE) -- CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced that it has received CE marking for its AlloSeq HCT chimerism testing kit and AlloSeq HCT interpretation software for use in patients who have received hematopoietic cell transplantation (HCT). “Transplantation is global and CareDx is proud to expand its leadership in Europe with CE marked AlloSeq HCT to help improve care for hematopoietic cell transplant patients,” said Reg Seeto, CEO and President of CareDx. “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.” AlloSeq HCT is an innovative, next-generation sequencing (NGS) based chimerism test used to monitor engraftment and evaluate the success of a hematopoietic stem cell transplant by measuring the relative ratio of the recipient and the donor cell population post-transplantation. “I am pleased to learn that CareDx has gained CE marking for its ultrasensitive NGS-based AlloSeq HCT test as the data suggests it achieves a high level of sensitivity and overcomes the limitations of current chimerism testing which rely on the detection and quantification of short tandem repeats to evaluate donor cell engraftment,” said Dr. Jean Villard, Professor of Clinical Immunology and Transplant Immunology, Geneva University Hospital. “I look forward to begin using AlloSeq HCT chimerism testing to monitor patients receiving a hematopoietic cell transplant.” Chimerism testing is a critical tool for monitoring engraftment after HCT. The most common method for chimerism testing in HCT recipients is based on short tandem repeats (STR). STR testing has a higher limit of detection and is not sensitive enough to allow engraftment monitoring to potentially predict early relapse of the disease.1,2 About CareDx – The Transplant Company Forward Looking Statements CONTACTS: CareDx, Inc. Investor Relations References:
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