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CareDx Partners with the North American Pediatric Renal Trials and Collaborative Studies (NAPRTCS) Organization in Launching Prospective, Multi-Center Pediatric Kidney Transplant Study

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CareDx, Inc. has partnered with the North American Pediatric Renal Trials and Collaborative Studies (NAPRTCS) to utilize their pediatric patient registry for a long-term outcomes study of AlloSure, a donor-derived cell-free DNA service aimed at improving organ transplant care in pediatric kidney patients. The study will track data for five years or until its conclusion, validating the utility of dd-cfDNA testing in managing long-term patient outcomes. This collaboration highlights CareDx's commitment to providing innovative solutions for pediatric transplant patients.

Positive
  • Partnership with NAPRTCS for a long-term study on dd-cfDNA's utility.
  • AlloSure's first publication in pediatric patients enhances credibility.
  • Potential to improve care and outcomes for pediatric kidney transplant recipients.
Negative
  • Risks associated with the study's data collection process.
  • Potential uncertainties in achieving expected benefits from the partnership.

NAPRTCS’s Pediatric Patient Registry Will Be Used for Long-Term Outcomes Study Using AlloSure Surveillance to Improve Organ Transplant Care

SOUTH SAN FRANCISCO, Calif., Dec. 13, 2021 (GLOBE NEWSWIRE) -- 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 a partnership with the North American Pediatric Renal Trials and Collaborative Studies (NAPRTCS) organization to use their patient registry to evaluate the long-term impact of using AlloSure® Kidney, a donor-derived cell-free DNA (dd-cfDNA) service, for routine organ transplant surveillance in pediatric kidney patients.

AlloSure had the first publication in pediatric patients titled, “Donor-Derived Cell-Free DNA (dd-cfDNA) for Detection of Allograft Rejection in Pediatric Kidney Transplants” in the Pediatric Transplantation journal in November 2020.1 The partnership with NAPRTCS will further validate the utility of AlloSure surveillance over long-term patient management. Data will be collected from participating centers by NAPRTCS for five years or until the study concludes the utility of dd-cfDNA, whichever is sooner. The objectives of the study are to characterize the use of dd-cfDNA testing and measure longitudinal outcomes following transplantation.

“Pediatric transplant patients need innovative solutions to monitor their care, and I am proud of our commitment to leading with a scientific focus on studies that can continue to bring new insights to this most important patient population. AlloSure had the first publication specifically on dd-cfDNA utility for pediatric patients, and we continue to lead innovation in this space by partnering with NAPRTCS,” said Reg Seeto, CEO and President of CareDx. 

“We believe partnering with CareDx will provide a great deal of important information about the care and outcomes of children who receive a kidney transplant based on the use of donor-derived cell-free DNA (dd-cfDNA) testing” said Alicia Neu, MD, President of NAPRTCS’ Board of Directors. “We thank CareDx for their ongoing collaboration with NAPRTCS and look forward to the results of this study and the guidance it provides us in caring for these young patients.”

Pediatric kidney transplant recipients require many decades of graft function and research shows that graft failure rates are higher during adolescence and young adulthood than at any other age.2 AlloSure Kidney’s ability to offer early warnings of possible allograft injury can help inform timely interventions for these pediatric patients, extending the life of the donated organ.

About NAPRTCS
The North American Pediatric Renal Trials and Collaborative Studies (NAPRTCS) is a research effort organized in 1987. The NAPRTCS patient registry follows the clinical course and natural history of children with renal dysfunction from participating sites across North America. It follows these patients as they move across the treatment continuum from chronic kidney disease to dialysis and transplantation. For more information, visit www.naprtcs.org.

About CareDx – The Transplant Company
CareDx, Inc., headquartered in South San Francisco, 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.

CONTACTS:
CareDx, Inc.
Sasha King
Chief Marketing Officer
415-287-2393
sking@CareDx.com

Investor Relations
Ian Cooney
(415) 722-4563
investor@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, including with respect to its accuracy and the quality of studies with respect thereto, and the partnership with NAPRTCS. 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 the CareDx does not realize the expected benefits of AlloSure® Kidney and partnership with NAPRTCS; risks that NAPRTCS fails to collect data from participating centers in the partnership study as planned; 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, 2020 filed by CareDx with the SEC on February 24, 2021 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. Puliyanda DP, Swinford, R, Pizzo, H, et al. Donor-derived cell-free DNA (dd-cfDNA) for detection of allograft rejection in pediatric kidney transplants. Pediatric Transplantation. 2021; 25:e13850. 
  2. Foster BJ, Dahhou M, Zhang X, et al. Association between age and graft failure rates in young kidney transplant recipients. Transplantation. 2011 Dec 15;92(11):1237-43.


FAQ

What is the purpose of CareDx's partnership with NAPRTCS?

The partnership aims to evaluate the long-term impact of AlloSure on pediatric kidney transplant care.

What is AlloSure and how is it used in this study?

AlloSure is a donor-derived cell-free DNA service used for routine transplant surveillance in pediatric kidney patients.

How long will the NAPRTCS study last?

The study will track data for five years or until its conclusions are reached.

What are the expected outcomes of using AlloSure in pediatric patients?

The study aims to improve long-term outcomes and inform timely interventions for pediatric kidney transplant recipients.

When was the partnership with NAPRTCS announced?

The partnership was announced on December 13, 2021.

CareDx, Inc.

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