First Pediatric Study to Evaluate Use of AlloSure dd-cfDNA as Biomarker for Allograft BK Infection

Findings Add to Growing Body of Evidence Showing Clinical Value of AlloSure for Surveillance in Pediatric Kidney Transplant Patients

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 the results of a new study published in the Clinical Journal of the American Society of Nephrology (CJASN)¹ showing that CareDx’s AlloSure® Kidney donor-derived cell-free DNA (dd-cfDNA) solution identifies early signs of allograft rejection and BK virus infection in pediatric kidney transplant patients.

“As a leader in transplant innovation, we are thrilled with this independent study showing the clinical utility of AlloSure Kidney in the longitudinal surveillance of pediatric patients,” said Reg Seeto, CEO and President of CareDx. “Pediatric recipients require many decades of graft function, and we are proud of AlloSure’s ability to offer early warnings of rejection that can help inform timely interventions to extend the life of the donated organ.”

The independent retrospective study performed at Washington University in St. Louis School of Medicine, analyzed blood samples taken monthly in the first-year post-transplant from fifty-seven pediatric kidney transplant patients. AlloSure was able to discriminate between biopsy-proven acute rejection with receiver operating characteristic area under the curve (AUC) of 0.82 (95% CI 0.71 to 0.93). Additionally, AlloSure was able to detect BK infection, and patients had a significantly higher median dd-cfDNA than the samples before BK diagnosis or after treatment.

“As a result of this study, pediatric kidney transplant physicians now have longitudinal data on the clinical utility of using AlloSure donor-derived cell-free DNA as a molecular biomarker to detect acute T-cell-mediated rejection and for the management of BK virus infection,” said Vikas Dharnidharka, MD, Pediatric Nephrology Division Chief and transplant researcher, Washington University in St. Louis.

For more details, read the publication 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 AlloSure Kidney on transplant patients and the value of the independent study on AlloSure Kidney conducted by the University of Washington Medical Center (the “Study”). 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 the AlloSure Kidney or the Study; risks that the results of the Study may not be accurate; 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, 2021 filed by CareDx with the SEC on February 24, 2022, the quarterly report on Form 10-Q for the quarter ended March 31, 2022 filed by CareDx with the SEC on May 5, 2022, the quarterly report on Form 10-Q for the quarter ended June 30, 2022 filed by CareDx with the SEC on August 4, 2022, 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. Longitudinal Evaluation of Donor-Derived Cellfree DNA in Pediatric Kidney Transplantation, Dandamudi R, Gu H, Goss CW, et al. CJASN Oct 2022, CJN.03840322; DOI: 10.2215/CJN.03840322

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