CareDx Launches HistoMap Kidney Tissue-Based Test to Enhance Transplant Rejection Diagnosis
核心洞察
CareDx announced the launch of HistoMap Kidney (搜索), a tissue-based molecular test that uses gene expression profiling to objectively characterize rejection type and enhance biopsy results for kidney transplant patients.
New clinical data presented at ASN Kidney Week 2025 demonstrated that AlloSure Plus (搜索), an AI-powered rejection risk assessment tool, showed performance for predicting antibody-mediated rejection (搜索) in kidney transplants.
Studies revealed that AlloSure (搜索) levels remained consistent regardless of donor kidney size across 54 living donor recipients, supporting its use as a robust biomarker for allograft injury (搜索) in both adult and pediatric patients.
CareDx, Inc. announced the launch of HistoMap Kidney (搜索), a tissue-based molecular test that leverages gene expression profiling to provide objective characterization of rejection types in kidney transplant patients. The precision medicine company also presented new clinical data at American Society of Nephrology (ASN) Kidney Week 2025 demonstrating the effectiveness of its molecular biomarker technologies in advancing transplant care.
Novel Tissue-Based Molecular Testing Platform
HistoMap Kidney (搜索) represents a significant advancement in transplant diagnostics by combining histology with genomics to deliver deeper insights into immune activity and rejection phenotypes. The test complements traditional pathology results with molecular information, providing clinicians with more comprehensive diagnostic insights for therapy selection.
"The HistoMap Kidney (搜索) launch marks a significant step in our commitment to end-to-end transplant care, bridging histology with genomics to improve diagnosis and therapy selection for kidney transplant patients," said John Hanna, President and CEO of CareDx. "By delivering a more comprehensive and actionable map of kidney health, we're empowering clinicians to make more precise and timely decisions for their patients."
The company plans to make HistoMap Kidney (搜索) available early 2026 through a clinical study, extending CareDx's leadership in kidney transplant molecular testing.
Clinical Evidence Supporting AI-Powered Rejection Assessment
New data presented at ASN Kidney Week showcased the performance of AlloView, now known as AlloSure Plus (搜索), an AI-powered rejection risk assessment tool. The study by Swamy V, et al. demonstrated that AlloSure Plus, which integrates AlloSure (搜索) with standard-of-care parameters, showed performance for predicting antibody-mediated rejection (搜索) (AMR) in kidney transplant patients.
Donor Characteristics Do Not Impact Biomarker Performance
A single-center study examining 54 living donor recipients revealed that donor kidney volume did not significantly impact AlloSure (搜索) levels or 1-year graft function. The research by Aloia S, et al. showed that AlloSure values remained consistent regardless of kidney size, supporting its use as a robust biomarker for allograft injury (搜索) in both adult and pediatric patients.
Early Post-Transplant Monitoring Capabilities
Research by Haririan A, et al. demonstrated that AlloSure (搜索) and blood gene expression profiling were not confounded by early graft function status. These results support the use of these molecular tools for rejection screening starting at week 1 post-transplant, enabling earlier detection and intervention.
Late-Breaking Research Highlights
Additional late-breaking abstracts presented at the conference included studies on donor-derived cell-free DNA predicting long-term graft outcomes through the Kidney Allograft Outcomes AlloSure (搜索) Registry (KOAR) results, and research on using cell-free DNA and gene expression profiling to facilitate belatacept monotherapy in kidney transplant patients.
The comprehensive data presentations underscore CareDx's position in developing molecular biomarkers that advance precision medicine approaches in transplant care, with applications spanning from early post-transplant monitoring to long-term graft outcome prediction.