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Independent Longitudinal Study Finds CareDx’s AlloSure Detects Early Signs of Rejection in Pediatric Kidney Transplant Patients
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CareDx, Inc. announced a study published in the Clinical Journal of the American Society of Nephrology demonstrating the efficacy of AlloSure® dd-cfDNA as a biomarker for early detection of allograft rejection and BK virus infection in pediatric kidney transplant patients. This independent study involved 57 patients and showed significant results, including an AUC of 0.82 for acute rejection detection. The findings emphasize AlloSure's potential for improving transplant outcomes through timely interventions, supporting CareDx's position as a leader in transplant innovation.
Positive
AlloSure's dd-cfDNA effectively identifies early signs of allograft rejection and BK virus infection.
Study showed a receiver operating characteristic AUC of 0.82 for detecting acute rejection.
Results support the clinical utility of AlloSure in pediatric kidney transplant patient surveillance.
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None.
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
BRISBANE, Calif.--(BUSINESS WIRE)--
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.
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:
Longitudinal Evaluation of Donor-Derived Cellfree DNA in Pediatric Kidney Transplantation, Dandamudi R, Gu H, Goss CW, et al. CJASNOct 2022, CJN.03840322; DOI: 10.2215/CJN.03840322
What does the new study published by CareDx on AlloSure reveal?
The study shows that AlloSure dd-cfDNA can effectively detect early signs of allograft rejection and BK virus infection in pediatric kidney transplant patients.
What is the significance of the AUC value reported in the CareDx study?
The study reported an AUC of 0.82, indicating a strong ability of AlloSure to discriminate between biopsy-proven acute rejection.
How many pediatric kidney transplant patients were analyzed in the CareDx study?
The study analyzed blood samples from 57 pediatric kidney transplant patients.
When was the CareDx study on AlloSure published?
The study was published in October 2022 in the Clinical Journal of the American Society of Nephrology.
What is CareDx's focus in the healthcare market?
CareDx focuses on the discovery, development, and commercialization of high-value healthcare solutions specifically for transplant patients.
