Natera announces publication of dd-cfDNA study data

Natera announced a new publication from the ProActive study in Transplantation supporting the use of the Prospera Kidney donor-derived cfDNA, or dd-cfDNA, test as a leading indicator of kidney transplant rejection. The published manuscript can be found here. The ProActive study is the largest prospective dd-cfDNA study in kidney transplant recipients, with roughly 5,000 patients enrolled at 54 participating transplant centers. This published study included 1,631 patients with =18 months of follow-up data. Key findings include: dd-cfDNA levels were significantly elevated up to five months before biopsy-proven antibody-mediated acute rejection, or ABMR, and up to two months before biopsy-proven T cell-mediated rejection, or TCMR, compared to patients with a non-rejection biopsy. In contrast, serum creatinine levels were not significantly elevated at any time point before biopsy-proven TCMR or ABMR. Multiple increased dd-cfDNA results were associated with lower eGFR, high immunological risk factors, and suspected ABMR in the absence of rejection on biopsy. These data further support the Prospera Kidney test’s value as an early indicator of rejection vs biopsy. Real-world performance of the Prospera Kidney test to detect all forms of rejection in 249 patients with matched biopsy demonstrated an area under the curve of 0.88, showcasing performance consistent with prior validations.