Surveillance Monitoring with Both AlloSure Kidney and the AlloView AI-Enabled Risk Prediction Model Improves the Detection of All Types of Allograft Rejection

AlloSure Kidney Detected Subclinical Rejection in Clinically Stable Patients and AlloSure Kidney dd-cfDNA Levels were Elevated Prior to Biopsy Proven Rejection in an Analysis of Patients Receiving Consecutive Biopsies

AlloSure dd-cfDNA Levels Declined in Response to Immunosuppression Treatment Suggesting There May be Utility in Therapy Monitoring for Recovery or Progression

CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced in conjunction with the 2024 American Transplant Congress, the publication in Nature Medicine¹ of findings from the largest, real-world study of its kind, assessing the role of AlloSure^® donor-derived cell-free DNA (dd-cfDNA) and of an AI-enabled rejection risk prediction model, AlloView™ that incorporates AlloSure to improve detection, characterization, and treatment of kidney allograft rejection.

“This landmark study in Nature Medicine further establishes the clinical utility of AlloSure Kidney and the added value of AlloView, our AI-enabled risk prediction model, in detecting the presence, activity and severity of allograft rejection. These findings contribute to a growing body of evidence establishing new standards globally in the routine monitoring of rejection and treatment response in kidney transplant patients," said John W. Hanna, President & CEO of CareDx.

The international multicenter study of 2,882 patients with AlloSure Kidney dd-cfDNA levels and matched biopsy results was conducted by the Paris Institute for Transplantation and Organ Regeneration along with researchers in the U.S. and Belgium. The study evaluated AlloSure Kidney and used AlloView, an AI-enabled risk prediction model, to predict rejection by combining AlloSure with standard of care measures, including estimated glomerular filtration rate (eGFR), proteinuria, change in serum creatinine, donor-specific antibodies (DSA), and previous history of rejection.

The study results published in Nature Medicine demonstrated the following¹:

• Surveillance monitoring with AlloSure Kidney and AlloView improves the detection of antibody-mediated rejection (ABMR), T-cell mediated rejection (TCMR), and subclinical rejection when compared to standard of care measures.
• AlloSure Kidney detected subclinical rejection in clinically stable patients.
• AlloSure Kidney dd-cfDNA levels were elevated prior to biopsy proven rejection in an analysis of patients receiving consecutive biopsies.
• AlloSure Kidney dd-cfDNA levels were associated with stability in patients with immune quiescence, a significant increase for patients with de novo allograft rejection, a significant decrease for patients with successfully treated rejection, and remained at elevated levels for patients with persistent allograft rejection.
• In patients with acute rejection, AlloSure Kidney dd-cfDNA levels were associated with the severity of acute rejection.

“This study underscores AlloSure dd-cfDNA’s role as a real-time indicator of kidney transplant rejection, enabling clinicians to intervene earlier before rejection occurs and to monitor post-treatment progress without resorting to unnecessary biopsy procedures,” said Alexandre Loupy, MD, PhD, Professor of Nephrology and Statistics at Necker Hospital, and Director of the Paris Institute of Transplantation and Organ Regeneration at the French National Institute of Health (Inserm).

CareDx’s AlloSure dd-cfDNA was made commercially available in 2017, the industry’s first dd-cfDNA for use to non-invasively identify the risk of allograft injury and rejection in kidney transplantation. Since then, AlloSure has also become available for clinical use in heart and lung transplant recipients. AlloView, an AI-enabled risk prediction model is now commercially available. AlloView optimizes patient risk prediction by integrating artificial intelligence, AlloSure and standard of care measures.²

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 AlloSure and AlloView. 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 and AlloView; risks that the findings in the Nature Medicine study 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. Aubert, O., Ursule-Dufait, C., Brousse, R., et al. Cell-Free DNA for the detection of kidney allograft rejection. Nat Med (2024). https://doi.org/10.1038/s41591-024-03087-3
2. AlloView is intended to support the healthcare provider’s independent assessment of the patient’s post-transplant status. AlloView is not intended to diagnose a condition or determine a patient’s course of treatment. An AlloSure dd-cfDNA test result is a required input of AlloView.

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