CareDx Announces Study Showing AlloSeq cfDNA Highly Accurate in Detecting Rejection in Organ Transplant Patients

AlloSeq cfDNA Consistent with Performance of Proven AlloSure TestingCareDx Brings Innovative Non-Invasive Transplant Monitoring to Patients Internationally with AlloSeq cfDNA

CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ – a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced findings published in Transplant International¹ that show the performance of AlloSeq™ cfDNA in detecting allograft rejection was consistent with its AlloSure® lab developed test.

Kidney allograft rejection is the leading cause of graft failure in kidney transplant patients. Early identification and treatment of rejection is critical to reduce allograft injury and prevent irreversible damage to the transplanted organ. Traditional tests such as serum creatinine, proteinuria and the formation of donor specific antibodies (DSA) are lagging indicators of kidney allograft rejection. In this first large-scale comparative study of its kind, AlloSure and AlloSeq cfDNA demonstrate consistent performance in detecting both clinical and subclinical rejection.

“This large-scale multicenter study confirms that the AlloSeq cfDNA IVD kit performance in detecting allograft rejection is highly consistent with the broadly implemented and well-characterized AlloSure Kidney testing service,” said Dr. Alexandre Loupy, Professor of Nephrology and Epidemiology at the Necker Hospital, in Paris, and Director of Inserm French NIH unit and head of the Paris Institute for Transplantation and Organ Regeneration (PITOR). “We believe that this study will be a key driver in increasing adoption of cell-free DNA in monitoring patients for early signs of rejection.”

The multicenter prospective study included 580 kidney transplant patients from three referral transplant centers in Europe. The study showed that AlloSeq cfDNA was highly accurate in detecting allograft rejection in kidney transplant patients, with a significant difference between rejection and non-rejection (p<0.0001) and an AUC of 0.758. Consistency in performance between AlloSeq cfDNA and AlloSure Kidney dd-cfDNA was confirmed across clinical scenarios including post-transplant timepoints, allograft stability, and allograft rejection subcategories; each compared to biopsy proven rejection.

“This study demonstrates the strong performance of our AlloSeq cfDNA kit in assessing allograft rejection in kidney transplant patients,” said John W. Hanna, CareDx President and CEO. “We look forward to physicians’ use of this data to expand the use of our innovative, high-performance allograft monitoring solutions internationally. Approximately 18,000 kidney transplants are performed in the European Union annually. By identifying early signs of rejection with AlloSeq cfDNA, physicians can intervene earlier to prevent irreversible organ injury and failure and improve long-term outcomes for their patients.”

To read the publication, go here.

AlloSeq cfDNA is available with CE-IVD marking in the E.U. and in the U.K. Not available in the U.S.

About CareDx – The Transplant Company

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 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 AlloSeq cfDNA and AlloSure dd-cfDNA. 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 numerous risks and uncertainties, all of which are difficult to predict and many of which are beyond CareDx’s control, that could cause actual results to differ materially from those projected, including risks that CareDx does not realize the expected benefits of AlloSeq cfDNA or AlloSure or risks that the findings published in the Transplant International study supporting the data may be inaccurate. These statements are also subject to general economic and market factors; and other risks discussed in CareDx’s filings with the Securities and Exchange Commission (the “SEC”), including, but not limited to, the Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed by CareDx with the SEC on February 28, 2024, the Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 filed by CareDx with the SEC on May 9, 2024 and the Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2024 filed by CareDx with the SEC on July 31, 2024, the Quarterly Report on Form10-Q for the quarter ended September 30, 2024 filed by CareDx with the SEC on November 4, 2024, 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. You are cautioned not to place undue reliance on these forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements,whether as a result of new information, future events or otherwise.

References:

1. Loupy, A, Certain, A, Tangprasertchai, NS, et al. Evaluation of a Decentralized Donor-Derived Cell-Free DNA Assay for Kidney Allograft Rejection Monitoring. Transplant International (2024). DOI=10.3389/ti.2024.13919

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