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.”
