CareDx Receives CE Mark for AlloSeq HCT for Use in Hematopoietic Cell Transplantation

·4 min read
CareDx, Inc.
CareDx, Inc.

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
CareDx, Inc., headquartered in South San Francisco, 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 testing services, products, 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.

Forward Looking Statements
This press release includes forward-looking statements related to CareDx, Inc., including statements regarding the potential benefits and results that may be achieved with CareDx’s AlloSeq portfolio, including AlloSeq HCT, and the CE marking for AlloSeq HCT. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including risks that CareDx does not realize the expected benefits of the AlloSeq portfolio, including AlloSeq HCT, and the CE marking for AlloSeq HCT; general economic and market factors; and other risks discussed in CareDx’s filings with the SEC, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2021 filed by CareDx with the SEC on February 24, 2022, the quarterly report on Form 10-Q for the first quarter of 2022 ended on March 31, 2022 filed by CareDx with the SEC on May 5, 2022, and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.

CONTACTS:

CareDx, Inc.
Sasha King
Chief Marketing Officer
415-287-2393
sking@caredx.com

Investor Relations
Ian Cooney
(415) 722-4563
investor@caredx.com

References:

  1. Calderin-Sollet Z, Kyle P, Casas S, et al. Quantification of Chimerism and Graft Immune Cell Composition with AlloSeq HCT, a Highly Sensitive and Precise Next-Generation Sequencing Assay, in Patients Post-Hematopoietic Stem Cell Transplantation. Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR, February 8-12, 2021, digital meeting.

  2. Blouin AG, Askar M. Chimerism analysis for clinicians: a review of the literature and worldwide practices. Bone Marrow Transplant. 2022 Mar;57(3):347-359. doi: 10.1038/s41409-022-01579-9.


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