CareDx Study Shows AlloSeq cfDNA Accurately Detects Organ Rejection
CareDx, Inc. (Nasdaq: CDNA), a leader in precision medicine for transplant patients, announced new findings published in Transplant International. The study demonstrated that the performance of AlloSeq™ cfDNA in detecting allograft rejection was in line with the results from its AlloSure® lab-developed test. This further validates the clinical effectiveness of AlloSeq™ cfDNA in transplant care.
Kidney allograft rejection is the primary cause of graft failure in kidney transplant patients. Early identification and treatment of rejection are crucial to reducing allograft injury and preventing irreversible damage to the transplanted organ. However, traditional diagnostic tests such as serum creatinine, proteinuria, and donor-specific antibodies (DSA) are lagging indicators and often fail to detect rejection in its early stages. In a pioneering large-scale comparative study, AlloSure and AlloSeq cfDNA demonstrated consistent and high performance in detecting both clinical and subclinical rejection in kidney transplant patients.
“This large-scale multicenter study confirms that the performance of the AlloSeq cfDNA IVD kit in detecting allograft rejection is highly consistent with the well-established AlloSure Kidney testing service,” said Dr. Alexandre Loupy, Professor of Nephrology and Epidemiology at Necker Hospital in Paris. He is also the Director of Inserm French NIH unit and head of the Paris Institute for Transplantation and Organ Regeneration (PITOR). “This study will play a key role in increasing the adoption of cell-free DNA as a standard tool for monitoring patients for early signs of rejection,” he added.
The study was a prospective, multicenter trial involving 580 kidney transplant patients across three referral transplant centers in Europe. The results demonstrated that AlloSeq cfDNA was highly accurate in detecting allograft rejection, showing a significant difference between rejection and non-rejection (p<0.0001) with an area under the curve (AUC) of 0.758. Furthermore, the performance consistency between AlloSeq cfDNA and AlloSure Kidney dd-cfDNA was confirmed across various clinical scenarios. This included different post-transplant time points, allograft stability, and rejection subcategories, all compared to biopsy-proven rejection.
“These results underscore the strong capabilities of our AlloSeq cfDNA kit in assessing kidney transplant rejection,” said John W. Hanna, President and CEO of CareDx. “We’re thrilled that physicians will use this data to expand the global adoption of our innovative allograft monitoring solutions. With approximately 18,000 kidney transplants performed annually in the European Union alone, early detection of rejection through AlloSeq cfDNA allows for earlier intervention. This could prevent irreversible organ injury and failure, ultimately improving the long-term outcomes for transplant patients.”
The findings of the study have been published in the scientific community, offering new evidence of the effectiveness of AlloSeq cfDNA in monitoring kidney transplant rejection. The study also highlights the potential of AlloSeq cfDNA to enhance patient outcomes by enabling early detection and timely intervention.
AlloSeq cfDNA is available with CE-IVD marking in the European Union and the United Kingdom but is not yet available in the United States. The test provides clinicians with an advanced tool for detecting early signs of rejection, offering greater precision in managing kidney transplant patients and improving overall care.
About CareDx – The Transplant Company
CareDx, Inc., headquartered in Brisbane, California, is a leading precision medicine company focused on developing and delivering high-value healthcare solutions for transplant patients and their caregivers. The company offers a range of testing services, products, and digital healthcare solutions designed to support patients before and after their transplant journey. CareDx is also a pioneer in providing genomics-based information for transplant patients, helping physicians make more informed decisions for their patients’ care.
The company’s offerings include advanced diagnostics such as AlloSure® and AlloSeq cfDNA, both of which are designed to detect signs of allograft rejection in kidney transplant recipients. CareDx’s solutions are helping transform the way transplant patients are monitored, offering improved outcomes and better management of the transplant process.
The strong performance of AlloSeq cfDNA in this study highlights the company’s commitment to providing healthcare professionals with cutting-edge tools to improve transplant patient care. By detecting rejection at earlier stages, these innovative solutions enable earlier interventions, which can significantly improve the long-term prognosis of kidney transplant recipients.
With ongoing research and development, CareDx aims to continue advancing its solutions to enhance the transplant community’s ability to detect and manage organ rejection. Through these efforts, the company strives to improve the lives of transplant patients and contribute to better healthcare outcomes globally.
