Natera Announces Publication Of Largest Prospective dd-cfDNA Study In Kidney Transplantation

Author: Benzinga Newsdesk | April 11, 2024 08:10am

ProActive study shows Natera's Prospera Kidney™ test detects rejection five months before biopsy

Natera, Inc. (NASDAQ:NTRA), a global leader in cell-free DNA (cfDNA) testing, today announced a new publication from the ProActive study in Transplantation supporting the use of the Prospera Kidney donor-derived cfDNA (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 (ABMR) and up to two months before biopsy-proven T cell-mediated rejection (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.1-4

"The ProActive study reinforces the utility of dd-cfDNA for monitoring kidney transplant patients and identifying those most at risk for rejection early on," said Jonathan Bromberg, MD, professor of surgery and microbiology and immunology, vice chair for research at the University of Maryland School of Medicine, and principal investigator of the ProActive study. "By detecting elevations in dd-cfDNA before biopsy-proven rejection, we can open up a critical window of time when more effective treatments can be used to improve the chances of graft survival."

"Current transplant surveillance tools are often lagging or inaccurate, and have several known limitations," said Sangeeta Bhorade, MD, chief medical officer of organ health at Natera. "We believe the ProActive study provides robust evidence in support of regular surveillance with the Prospera dd-cfDNA test, which the industry has long been awaiting. Natera remains excited to continue pursuing additional clinical evidence and optimizing the management of kidney transplant patients for improved long-term outcomes."

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