Biopsy-matched study assesses pancreas rejection in the context of a simultaneous kidney-pancreas transplant
AUSTIN, Texas, March 22, 2022 /PRNewswire/ — Natera, Inc. (NASDAQ:NTRA), a global leader in cell-free DNA testing, today announced that a study1 reporting on the performance of donor-derived cell-free DNA (dd-cfDNA) testing using the Prospera™ technology for the assessment of pancreas graft rejection in simultaneous pancreas-kidney (SPK) transplantation has been published in Transplantation, the official Journal of The Transplantation Society.
The study, conducted at the Hospital Clinic of Barcelona, Spain, utilized Prospera technology to detect rejection of a pancreas graft in 36 SPK transplant recipients with pancreas biopsy-matched plasma samples. Pancreas graft status in SPK transplants is currently assessed by non-specific biochemical markers, typically amylase and/or lipase, and confirmed by biopsy.
As shown in the study results, the combination of dd-cfDNA donor fraction and quantity reported using Prospera technology outperformed both current biochemical markers and dd-cfDNA donor fraction-alone in assessing pancreas rejection. Dd-cfDNA quantity alone also demonstrated exceptional performance, detecting rejection with a sensitivity of 85.7% and a specificity of 93.7% and achieving an AUC of 0.89 compared to 0.74 for lipase and 0.46 for amylase.
“Our study clearly indicates that the use of routine dd-cfDNA testing can help clinicians better monitor and manage treatment options, particularly over the current tests which are highly unspecific,” said Pedro Ventura-Aguiar, M.D., Ph.D., the study’s author and principal investigator. “This data also cements the importance of incorporating dd-cfDNA quantity and not just looking at donor-fraction alone. It’s great that Natera can enable this type of analysis with Prospera.”
“We’ve previously validated the Prospera test for use in the clinical management of simultaneous pancreas-kidney transplant patients to detect kidney rejection,” said Bernie Tobin, general manager, organ health at Natera. “New advances may enable the ability to detect pancreatic rejection as well. SPK transplant recipients face a complex array of challenges and we’re pleased to be on the leading edge of research and striving to improve care for these patients.”
