CareDx, Inc. (NASDAQ: CDNA) announced the publication of a new analysis from the Kidney Allograft Outcomes AlloSure Registry (KOAR) in the Journal of the American Society of Nephrology.

The study evaluated the relationship between AlloSure Kidney donor-derived cell-free DNA (dd-cfDNA) and three-year kidney allograft outcomes in a cohort of 1,258 adult kidney transplant recipients across 56 U.S. centers.

Key findings from the analysis include that transitions to elevated AlloSure levels were associated with a 3.7-fold and 6.4-fold higher adjusted hazard of allograft loss for intermediate and high states, respectively. Approximately 36% of patients experienced dd-cfDNA elevation during follow-up. The study also found that most elevations occurred while kidney function remained preserved, indicating the test may detect subclinical injury before measurable decline in estimated glomerular filtration rate.

Patients with persistently low AlloSure levels experienced low rates of rejection, dysfunction, and graft loss over three years, according to the study.

"This analysis from the KOAR registry shows that elevations in dd-cfDNA are associated with meaningful differences in long-term allograft outcomes," said Jeffrey A. Klein, MD, of the Division of Nephrology at the University of Kansas.

Jonathan S. Bromberg, MD, PhD, Professor of Surgery at the University of Maryland School of Medicine, said the findings "suggest that tracking dd-cfDNA over time may offer a useful framework for risk stratification and longitudinal surveillance in kidney transplant recipients."

The KOAR registry is described as a multi-center study. This is the second manuscript published from the registry. The analysis applied a multistate modeling framework to assess how longitudinal changes in dd-cfDNA levels relate to subsequent allograft dysfunction and graft loss.