Announces the Launch of AlloSure® Plus Integrated into EPIC Aura

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 the presentation of several high-impact studies and digital health innovations by independent research teams at the 2025 World Transplant Congress (WTC), demonstrating advances in artificial intelligence, predictive diagnostics, transplant access, and organ-specific innovation.

These featured abstracts are part of more than 40 CareDx-featured presentations spanning kidney, lung, liver, and heart transplantation accepted at WTC 2025. The studies reflect the growing body of evidence supporting the clinical utility of CareDx technologies.

The company also announced the launch of AlloSure® Plus (formerly AlloView®), an AI-driven diagnostic platform that integrates AlloSure® donor-derived cell-free DNA (dd-cfDNA) analysis with traditional tools to provide a personalized risk of rejection. An international, prospective study led by the Paris Transplant Group validated AlloSure Plus to identify organ rejection using over 2,700 renal transplant biopsies. AlloSure Plus will be integrated with AlloSure results through EPIC Aura at initial launch sites in the third quarter of 2025 ahead of a broader rollout.

“These studies demonstrate the power of combining clinical insight with advanced technology to improve transplant care,” said John Hanna, President and CEO of CareDx. “Every innovation we advance, from AI diagnostics to transplant quality analytics, is driven by our commitment to improving patient access, outcomes, and care experiences. Our teams continue to push boundaries to ensure every patient receives the best possible support at every stage of their journey. We are proud of the depth of data being presented on our solutions at WTC, the premier global forum for clinically relevant transplant science.”

Featured Abstract Highlights

• Abstract OA33.3: Performance of Integrative dd-cfDNA in Detecting Rejection Based on the Updated Banff 2022 Classification
  
  With over 4,100 biopsies analyzed, this study found that AI-powered AlloSure Plus showed improved sensitivity and specificity for detecting rejection, including microvascular inflammation, an emerging hallmark of antibody-mediated rejection (AMR).
• Abstract OA59.4: Renal Transplant Recipients with Elevated Donor-Derived Cell-Free DNA Are at Increased Risk of Graft Loss
  
  Data from 1,258 patients in the KOAR registry revealed that kidney transplant recipients with elevated dd-cfDNA had an 8.166-fold increased risk of graft loss at 3 years, underscoring dd-cfDNA’s long-term prognostic value and potential for guiding early intervention.
• Abstract P3.07.183: Longitudinal dd-cfDNA Kinetics in Recipients of Hard-to-Place Kidneys
  
  In a cohort of 56 recipients of high-risk, hard-to-place kidneys, longitudinal AlloSure dd-cfDNA monitoring showed consistently low levels and excellent graft survival, supporting broader utilization of marginal organs and the role of dd-cfDNA in post-transplant surveillance.
• Abstract OA36.8: Impact of Persistently Elevated Simultaneous Gene Expression Profiling and Donor-Derived Cell-Free DNA on Future Clinical Events
  
  Among 2,240 heart transplant recipients (included from the Surveillance HeartCare Outcomes Registry (SHORE)), those with persistently elevated gene expression profiling (AlloMap) and dd-cfDNA (AlloSure) were nearly twice as likely to experience rejection, graft dysfunction, or cardiovascular death, highlighting the prognostic power of multimodal surveillance.

Additionally, CareDx will host a symposium on Monday, August 4, from 1:00 – 2:00 PM PDT titled, “Transforming Transplant Management with Precision Molecular Intelligence.” The session will feature presentations from leaders in kidney transplant care, including Nicole Ali, MD (NYU Langone Health), Dhiren Kumar, MD (Virginia Commonwealth University), Marta Sablik, MD (Paris Institute of Transplantation), and will be moderated by Alex Loupy, MD, PhD (Paris Transplant Group). The symposium will explore the evolving clinical contexts of use for AlloSure, including its role in immunosuppression management, surveillance in hard-to-monitor populations, and its association with long-term graft outcomes. The session will also preview emerging data from the KOAR study and European surveillance trials, and discuss the future of molecular diagnostics in transplant care.

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 have been or may be achieved with AlloSure Plus, AlloSure Kidney, AlloSure Heart, AlloMap Heart, HeartCare, and other CareDx products, and statements regarding the interim and completed study results of CareDx’s SHORE registry and KOAR study, as well as data presented at the 2025 WTC meeting (the “WTC Presentation”). 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 AlloSure Plus, AlloSure Kidney, AlloSure Heart, AlloMap Heart, HeartCare, and other CareDx products; risks that the WTC Presentation and the data to be presented may not follow the agenda as stated in this press release; risks that the findings in the studies supporting the data may be inaccurate, general economic and market factors, and other risks discussed in CareDx’s filings with the Securities and Exchange Commission (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.

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