CareDx Showcases AlloSure dd-cfDNA as Emerging Clinical Endpoint Across 30+ Abstracts at ATC 2026
核心洞察
CareDx presented over 30 abstracts and 9 oral presentations at ATC 2026, featuring data from more than 110 U.S. transplant centers on AlloSure (搜索) and related precision diagnostics.
Persistent AlloSure (搜索) elevation in the first four months post-kidney transplant was associated with higher rates of rejection, de novo DSA, eGFR decline, and graft loss at three years.
AlloSure (搜索) demonstrated utility as a sensitive marker of ongoing graft injury in a tocilizumab study for antibody-mediated rejection (搜索), remaining elevated despite DSA reductions.
CareDx, Inc. (Nasdaq: CDNA) announced its participation at the American Transplant Congress (ATC) 2026, taking place June 20–24 in Boston, Massachusetts, with a robust scientific presence spanning more than 30 abstracts and 9 oral presentations. The data, generated from studies at over 110 transplant centers across the United States, reflect the continued evolution of AlloSure (搜索) donor-derived cell-free DNA (搜索) (dd-cfDNA) from an emerging biomarker to a potential clinical endpoint in solid organ transplantation.
"The data at ATC reflect a clear shift: AlloSure (搜索) is evolving beyond its established role in transplant surveillance — it is being explored as a clinical endpoint to evaluate treatment response, stratify risk, and predict graft outcomes," said Dr. Jeffrey Teuteberg, Chief Medical Officer of CareDx. "That has meaningful implications for how clinicians manage patients and how the field designs the next generation of clinical trials."
Prognostic Value of Early AlloSure (搜索) Monitoring in Kidney Transplantation
A key study (Abstract 1332) demonstrated that persistent elevation of AlloSure (搜索) in the first four months after kidney transplantation was associated with higher rates of rejection, de novo donor-specific antibodies (DSA), estimated glomerular filtration rate (eGFR) decline, and graft loss at three years. In contrast, patients with transient AlloSure elevations that subsequently normalized showed outcomes comparable to those with consistently low levels, supporting the prognostic value of early AlloSure monitoring for long-term graft health.
AlloSure (搜索) as a Marker of Treatment Response
In a single-center prospective study of tocilizumab for antibody-mediated rejection (搜索) (AMR) (Abstract 574), AlloSure (搜索) levels remained elevated over 12 months despite reductions in DSA and stabilization of eGFR. These findings correlated with persistent histologic AMR on follow-up biopsy, supporting AlloSure as a sensitive marker of ongoing graft injury and treatment response.
AlloSure (搜索) and Microvascular Inflammation Phenotypes
A multicenter analysis of more than 4,000 kidney transplant recipients across 28 centers (Abstract 1334) found that elevated AlloSure (搜索) was independently associated with microvascular inflammation (MVI) phenotypes, including DSA-negative, C4d-negative MVI. This highlights AlloSure's role as a non-invasive marker of active alloimmune injury beyond conventional antibody-mediated rejection (搜索) classifications.
AlloSure (搜索) Plus for Precision Risk Stratification
AlloSure (搜索) Plus scores were significantly higher in biopsy-confirmed acute cellular rejection (ACR) and AMR compared to no rejection, with an area under the receiver operating characteristic curve (AUROC) of 0.79 for discriminating rejection, supporting precision risk stratification beyond dd-cfDNA alone (Abstract D075).
Molecular Reclassification of Isolated Arteritis
HistoMap Kidney molecular analysis (Abstract C367) classified the majority of biopsies with isolated arteritis (v-lesions) as "No Rejection," suggesting that isolated arteritis may not represent active T-cell-mediated rejection. This finding supports the use of molecular diagnostics to refine rejection diagnosis and guide treatment decisions.
ImmuneScape: Single-Cell and Spatial Transcriptomics Advances
Integration of single-cell and spatial transcriptomics as part of the ImmuneScape platform (Abstract C059) revealed distinct immune cell populations and spatial immune infiltration patterns associated with kidney allograft rejection (搜索). This work provides a framework for the discovery of novel biomarkers, improved molecular rejection classification, and future precision therapies.
Heart Transplantation Findings
In heart transplantation (Abstract 790), higher AlloMap scores were significantly associated with subsequent elevations in AlloSure (搜索) Heart, with risk increasing at gene expression profiling (GEP) scores of 25 or greater. This supports AlloMap as an early indicator of immune activation that may precede graft injury detected by dd-cfDNA alone. Additionally, patients initiated on mammalian target of rapamycin inhibitor (mTORi) therapy showed increased evidence of molecular rejection as detected by HeartCare, suggesting that more frequent non-invasive monitoring may be warranted in this population (Abstract 793).
Multiorgan Transplantation
HeartCare was routinely incorporated into post-transplant follow-up for simultaneous heart-kidney transplant recipients, with investigators demonstrating predictable patterns in molecular testing results through consistent testing frequency (Abstract C365).
CareDx Symposium
A panel of transplant nephrologists, moderated by David Wojciechowski, DO of UT Southwestern and featuring experts from Northwestern Medicine, NYU Langone, University of Washington, and Weill Cornell Medicine, will discuss the application of AlloSure (搜索) Kidney and AlloSure Plus in clinical decision-making during an interactive case-based symposium on June 21, 2026, featuring data from the recently published second manuscript of the KOAR study.