Natera, a global leader in cell-free DNA (cfDNA) testing, announced the publication of the latest data from the Trifecta study in Transplantation, found here. The investigators found that in predicting antibody mediated rejection (AMR), donor-derived cell-free DNA (dd-cfDNA) testing with the Prospera Kidney test was superior to the current standard of care, donor-specific antibody (DSA) testing.
In the study, both components of the Prospera two-threshold algorithm, dd-cfDNA donor fraction (AUC 0.84) and estimated amount of dd-cfDNA (AUC 0.85), outperformed DSA (AUC 0.66) in identifying AMR. Societal guidelines currently recommend DSA testing as standard practice for monitoring AMR, highlighting a compelling consideration for the broader use of dd-cfDNA in kidney transplantation.
This manuscript is the latest out of the Trifecta study, led by principal investigator Phil Halloran, MD, PhD, director of the Alberta Transplant Applied Genomics Centre. The investigators assessed dd-cfDNA donor fraction, estimated amount of dd-cfDNA and DSA-status for 280 samples from kidney transplant recipients matched to kidney biopsies evaluated by both RNA-based molecular pathology (Molecular Microscope Diagnostic System, “MMDX”) and histology (Banff Classification of Allograft Pathology, 2019).
“These data further strengthen the case to incorporate dd-cfDNA into routine practice for the assessment of solid organ transplant rejection,” says Halloran. “DSA has been a staple in the transplant physician’s repertoire for a long time, but it’s increasingly clear that we also need to adopt newer technologies, like dd-cfDNA, to develop a more complete clinical picture of patients’ graft status.”
Twelve peer-reviewed manuscripts have been published since 2021 featuring Natera’s Organ Health products, including another recent publication from the Trifecta study validating the novel two-threshold algorithm in the Prospera test.
