CareDx Extends Leadership in Kidney Transplant Molecular Testing with Launch of Unique Tissue-Based Gene Expression Assay – HistoMap Kidney

CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ – a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced new data presentations featuring CareDx technologies at American Society of Nephrology (ASN) Kidney Week 2025, underscoring the power of molecular biomarkers to advance transplant care.

The company also announced the launch of HistoMap™ Kidney, a tissue-based molecular test that objectively characterizes rejection type and enhances the clinical utility of biopsy results. By leveraging gene expression profiling, HistoMap Kidney delivers deeper insights into immune activity and rejection phenotypes. This approach complements pathology results with molecular information, providing more comprehensive diagnostic insights.

“The HistoMap Kidney 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.”

HistoMap Kidney will be available early 2026 through a clinical study.

The company’s commitment to innovation is reflected in the latest data featuring CareDx technologies presented at ASN Kidney Week, where new studies showcase how advanced diagnostics and molecular tools are shaping the future of kidney transplant care.

ASN Featured Presentations

• Poster, November 6, 2025, 10:00 AM – 12:00 PM
  
  AlloView in Kidney Transplant Rejection. Swamy V, et al.
  
  In this study, AlloView (now known as AlloSure Plus), an AI-powered rejection risk assessment tool, integrated AlloSure with standard-of-care parameters, and demonstrated performance for predicting antibody-mediated rejection (AMR).
  
  
  
  
• Poster, November 7, 2025, 10:00 AM – 12:00 PM
  
  Size Doesn't Matter? Effect of Donor Volume on Donor-Derived Cell-Free DNA in Kidney Transplant Recipients: A Single-Center Perspective. Aloia S, et al.
  
  
  
  This study showed that the volume of each donor kidney did not significantly impact AlloSure levels or 1-year graft function across 54 living donor recipients. AlloSure values remained consistent regardless of kidney size, supporting its use as a robust biomarker for allograft injury in both adult and pediatric patients.
  
  
  
  
• Poster, November 8, 2025, 10:00 AM – 12:00 PM
  
  Association of Donor-Derived Cell-Free DNA and Peripheral Blood Mononuclear Cells (PBMC) Gene Expression Profile with Graft Function Early After Kidney Transplant. Haririan A, et al.
  
  
  
  Results demonstrated that AlloSure and blood gene expression profiling were not confounded by early graft function status, supporting their use for rejection screening starting at week 1 post-transplant.

Late-Breaking Abstracts:

• dd-cfDNA Predicts Long-Term Graft Outcomes: Kidney Allograft Outcomes AlloSure Registry (KOAR) Results
  
  Wojciechowski D et al, The University of Texas Southwestern Medical Center
  
  
  
  
• Cell-free DNA (AlloSure) and Gene Expression Profiling to Facilitate Belatacept Monotherapy in Kidney Transplant Patients
  
  Salcedo-Betancourt J, et al, The University of Texas Southwestern Medical Center

About CareDx

CareDx, Inc., headquartered in Brisbane, California, is a precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. For more information, visit www.caredx.com.

Forward Looking Statements

This press release includes forward-looking statements related to CareDx, Inc., including statements regarding the potential benefits and results that may be achieved with HistoMap Kidney, AlloSeq, AlloMap, AlloView, and AlloSure Plus expected launch timing of CareDx products, and other CareDx products and statements regarding the data to be presented at the annual American Society for Histocompatibility and Immunogenetics meeting. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including risks that CareDx does not realize the expected benefits of HistoMap Kidney, AlloSeq, AlloMap, AlloView, AlloSure Plus and other CareDx products; risks that the data to be presented at the ASN may not follow the agenda as stated in this press release; risks that the findings in the studies supporting the data may be inaccurate; risks that CareDx products may not launch on the expecting timing or at all; general economic and market factors; and other risks discussed in CareDx’s filings with the SEC, including, but not limited to the Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed by CareDx with the SEC on February 28, 2025, and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

AlloSeq is a trademark or registered trademark of CareDx Inc. or its subsidiaries in the US or other countries. AlloSeq is a registered trademark with the US Patent and Trademark Office. © 2025 CareDx, Inc. All service marks or trademarks are owned or licensed by CareDx, Inc. or its affiliates. All rights reserved.

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