BRISBANE, Calif. | June 16, 2026
CareDx, Inc. has announced the publication of the second analysis from the Kidney Allograft Outcomes AlloSure Registry (KOAR) in the Journal of the American Society of Nephrology (JASN), providing new real-world evidence supporting the use of AlloSure® Kidney donor-derived cell-free DNA (dd-cfDNA) for long-term monitoring of kidney transplant recipients. The multicenter study demonstrated that elevated AlloSure® Kidney levels are strongly associated with an increased risk of kidney allograft dysfunction and graft loss, reinforcing the role of the non-invasive molecular test in longitudinal risk stratification and personalized clinical decision-making. The findings further strengthen the growing evidence that dd-cfDNA can detect early signs of transplant injury before conventional measures of kidney function begin to decline.
KOAR Registry Links AlloSure Elevations to Poorer Outcomes
The published analysis evaluated 1,258 adult kidney transplant recipients treated across 56 transplant centers in the United States using data from the landmark KOAR Registry. Investigators applied a multistate statistical model to examine how changes in AlloSure® Kidney dd-cfDNA over time influenced long-term transplant outcomes. During the three-year follow-up period, approximately 36% of patients experienced elevated dd-cfDNA levels, indicating a transition from lower-risk to higher-risk clinical states. Patients with intermediate AlloSure elevations experienced a 3.7-fold higher adjusted risk of graft loss, while those reaching high-risk dd-cfDNA levels had a 6.4-fold greater risk compared with patients who maintained consistently low biomarker levels. The results demonstrate that even a single elevation in AlloSure can signal a meaningful change in long-term transplant prognosis.
Early Detection Supports Personalized Patient Management
One of the study’s most important findings was that most AlloSure® Kidney elevations occurred while kidney function remained clinically preserved, indicating that dd-cfDNA may detect subclinical allograft injury before measurable declines in estimated glomerular filtration rate (eGFR) become apparent. In contrast, patients who maintained persistently low AlloSure levels experienced low rates of rejection, minimal graft dysfunction, and favorable long-term transplant outcomes throughout the three-year observation period. These findings highlight the value of routine longitudinal molecular monitoring, enabling clinicians to identify emerging transplant injury earlier and potentially intervene before irreversible damage develops. The study further supports the integration of dd-cfDNA testing into routine post-transplant surveillance strategies.
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Publication Strengthens Evidence for AlloSure Kidney
The latest publication adds to the expanding body of clinical evidence supporting AlloSure® Kidney as a clinically meaningful biomarker for transplant surveillance. According to CareDx, the findings demonstrate how ongoing monitoring of donor-derived cell-free DNA can improve risk assessment, support individualized treatment decisions, and enhance long-term graft management for kidney transplant recipients. As the KOAR Registry continues to generate real-world evidence, the data reinforce the growing role of precision medicine in transplantation by providing clinicians with earlier, non-invasive insight into graft health. The publication in JASN represents another important milestone for CareDx, strengthening confidence in molecular diagnostics as an essential component of modern kidney transplant care and long-term organ preservation.
Source: CareDx press release
