CareDx Announces New KOAR Data Linking Elevated AlloSure® Kidney to Nearly 3-Fold Higher Risk of Adverse Graft Outcomes in Patients with Borderline Rejection or TCMR at ASN Kidney Week 2026
In an independent randomized trial, AlloSure-based monitoring demonstrates a significant reduction in kidney transplant biopsies while maintaining similar clinical outcomes
A multinational study shows AlloSure Kidney & AlloSure Plus maintained strong rejection prediction under updated Banff 2024 pathology criteria
BRISBANE, Calif., October 22, 2026--CareDx, Inc. (Nasdaq: CDNA) — a leading precision medicine diagnostics company in transplant, specialty oncology, and cell therapy, today highlighted data featuring AlloSure® Kidney donor-derived cell-free DNA (dd-cfDNA) being presented at the American Society of Nephrology (ASN) Kidney Week 2026, taking place October 22–25 in Denver, Colorado.
The findings address several persistent challenges in kidney transplant management: determining the significance of ambiguous biopsy results, reducing reliance on invasive surveillance biopsies, and maintaining reliable rejection prediction as diagnostic criteria evolve. Together, the studies add to the evidence supporting AlloSure Kidney as a clinically useful tool for assessing graft injury and informing patient management.
"For decades, biopsy has been the reference standard for assessing rejection, despite being invasive; resulting in inconvenience, risk and stress for patients; and being resource-intensive for transplant programs," said Dr. Jeffrey Teuteberg, Chief Medical Officer of CareDx. "These data show how AlloSure Kidney can provide clinically meaningful information across several of the most difficult decisions in kidney transplant care, from identifying risk when biopsy findings are ambiguous to enabling a less invasive approach to monitoring. Combined with the long-term outcome data presented at this year's ATC, the evidence increasingly supports the use of AlloSure Kidney to help clinicians assess risk and guide patient management."
Key Study Findings in Kidney Transplantation:
In the newest KOAR registry analysis, 131 kidney transplant recipients with biopsy-proven borderline changes or T-cell-mediated rejection (TCMR) had AlloSure Kidney results obtained within 30 days prior to the biopsy. An AlloSure Kidney level of ≥1% was independently associated with a nearly 3-fold higher risk of allograft loss or ≥30% decline in kidney function (P=0.002). These findings support the potential role of AlloSure Kidney in helping clinicians identify patients with these biopsy results who are at increased risk of adverse graft outcomes. (Abstract PO-1194)
In an independent multinational randomized trial conducted by Paris Transplant Group of 332 kidney transplant recipients across seven centers in four European countries, found that between months 3 and 12, patients monitored with dd-cfDNA underwent 49% fewer biopsies than patients monitored with surveillance biopsies (IRR 0.51; P<0.001). Safety outcomes were similar between groups, including death or graft loss (7.1% vs. 6.1%), biopsy-proven acute rejection (7.1% vs. 7.3%), and kidney function at 12 months. (Abstract OR-104)
In an extended validation study conducted by Paris Transplant Group, which included 4,976 kidney transplant recipients and 6,827 biopsies from 29 centers across four continents, AlloSure Kidney and AlloSure Plus, a model that incorporates clinical parameters in addition to the AlloSure results, maintained strong rejection prediction under the updated Banff 2024 pathology criteria (AUC 0.833). (Abstract FR-PO1193)