NEW YORK – Organ transplant diagnostics company CareDx said on Monday that it has partnered with the North American Pediatric Renal Trials and Collaborative Studies organization to use its patient registry to evaluate the long-term impact of using CareDx's AlloSure Kidney donor-derived cell-free DNA (dd-cfDNA) diagnostic for routine organ transplant surveillance in pediatric kidney patients.
NAPRTCS, a research effort first organized in 1987, has a patient registry that 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.
Researchers at Cedars Sinai Medical Center and the University of Texas at Houston published a study in the journal Pediatric Transplantation in November 2020 showing the first data for the utility of AlloSure in pediatric patients. The paper concluded that dd-cfDNA was highly predictive of histological rejection and superior to other indicators such as graft dysfunction or antibody positivity alone. The company said it hopes its partnership with NAPRTCS will further validate the utility of AlloSure surveillance for long-term patient management.
NAPRTCS will collect data from participating centers 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, CareDx said.
Pediatric kidney transplant recipients can require decades of graft function, and research shows that graft failure rates are higher during adolescence and young adulthood than at any other age, the company added.
"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," CareDx CEO Reg Seeto said in a statement. "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."