AI-Derived AlloView Results Correlate with Presence and Type of Biopsy Proven Kidney Rejection

Longitudinal Monitoring with AlloSure Kidney Enables Earlier Identification of Graft Injury and Assessment of Rejection Treatment

KOAR Data Show Kidney Biopsies Informed by AlloSure Detect More Acute Rejection than Biopsies Based on Traditional Indications

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 to be presented at the 2024 American Transplant Congress (ATC) being held June 1-5 in Philadelphia.

CareDx solutions are featured in 36 oral presentations and posters, and a symposium. The findings highlight innovative approaches, including AI integration, and the real-world clinical utility of CareDx’s solutions, emphasizing their significant impact on patient care and outcomes in kidney, heart, and lung transplantation.

“The additive value of artificial intelligence to our transplant solutions holds significant promise,” said John W. Hanna, CareDx President and CEO. “We are proud to have a leading presence at ATC and showcase new data on AI-enabled rejection monitoring, the clinical value of longitudinal monitoring with AlloSure Kidney, and the potential for biopsy reductions with AlloSure Kidney in real-world settings.”

Key data to be presented at 2024 ATC:

• Utilization of Artificial Intelligence (AI) in Predicting the Risk of Kidney Allograft Rejection, S. V. Shah, S. Voora, P. J. Hanson, et al. Poster Abstract Session D148. This independent study establishes reference values for AlloView™, correlating results with the presence and type of allograft rejection observed on kidney biopsies. AlloView is the first AI-derived model to predict rejection risk in kidney transplant patients by integrating AlloSure Kidney with other clinical and laboratory factors associated with rejection.
• Time-Varying Relative Changes in Donor-Derived Cell-Free DNA (dd-cfDNA) during Rejection and dnDSA Detection in Primary and Repeat Kidney Transplant Recipients (KTR), S. Parajuli, N. Garg, K. Pinney, et al. Poster Abstract Session A184. This study highlights the importance of AlloSure® Kidney for longitudinal monitoring of dd-cfDNA trends, enabling earlier identification of evolving graft injury and evaluating rejection treatment response.
• Donor-Derived Cell-Free DNA Increases the Yield of Acute Rejection and Borderline TCMR on Kidney Transplant Biopsies, J. Bromberg, D. Mandelbrot, M. Weir, et al. Poster Abstract Session A174. An analysis of KOAR (Kidney Outcomes with AlloSure Registry) data show that kidney biopsies based on AlloSure alone or AlloSure and traditional laboratory indications, significantly enhance detection of actionable findings, yielding acute rejection and borderline T-cell mediated rejection (TCMR) in 48% of cases compared to 28% with traditional for-cause biopsy indications alone.
• Clinical Utility of Donor-Derived Cell-Free DNA during the Period of Recovery of Renal Function after Kidney Transplantation, R. D. Foresto, Y. C. Dreige, I. Meira, et al, Rapid Fire Oral Abstract Session 363. Data show that using a threshold of AlloSure Kidney dd-cfDNA of >0.5% to guide surveillance biopsies during delayed graft function (DGF) or at 30 days post-transplant in the setting of incomplete recovery of kidney function would have avoided 23% and 36% of biopsies, respectively.
• Characterization of GEP and dd-cfDNA Profile with Long-Term Malignancy Risk Post-Cardiac Transplant, L. Chen, D. H. Lee, E. Czinn, et al. Poster Abstract Session C062. The study reveals that patients developing cancer after heart transplantation have lower mean levels of both AlloMap® gene-expression profiling and AlloSure dd-cfDNA before cancer diagnosis compared to propensity-matched patients.

A leading group of experts in the field will present findings from the recent SHORE (Surveillance HeartCare Outcomes Registry) publication and the latest data featuring AlloSure Kidney and AlloView, the first AI-derived model to predict rejection risk in kidney transplant patients. The sponsored symposium¹, “From Invasive to Intelligent: Utilizing Cutting-Edge Artificial Intelligence and Molecular Diagnostics in Real-World Clinical Practice,” will be moderated by Kiran Khush, MD, MAS, Stanford Medicine. Panelists include Alexandre Loupy, MD, PhD, Paris Transplant Group, Darshana Dadhania, MD, Weill-Cornell Medicine, Gaurav Gupta, MD, Virginia Commonwealth University, and Sean Pinney, MD, Mount Sinai Morningside.

"I am thrilled to moderate this exciting symposium sponsored by CareDx as it will explore the latest advancements in transplant monitoring and highlight the recent landmark SHORE publication along with new data on AlloSure Kidney and AlloView. The integration of AI in predicting rejection risk marks a significant leap forward in patient care," said Kiran Khush, MD, MAS, Cardiologist, Professor of Cardiovascular Medicine, Stanford Medicine.

For a complete listing of abstracts, oral presentations and posters go here.

About CareDx – The Transplant Company

CareDx, Inc., headquartered in Brisbane, California, is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey and is the leading provider of genomics-based information for transplant patients. For more information, please 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 AlloView, AlloSure, AlloMap, and other CareDx products (including with the use of artificial intelligence), and statements regarding the data to be presented at the 2024 American Transplant Congress (ATC). 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 AlloView, AlloSure, AlloMap, and other CareDx products (including with the use of artificial intelligence); risks that the data to be presented at the ATC 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 SEC, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed by CareDx with the SEC on February 28, 2024, the Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 filed by CareDx with the SEC on May 9, 2024 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. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.

References:

1. The symposium is an independent, non-CME event.

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