Natera, a global leader in cell-free DNA testing, showcased its Prospera Lung donor-derived cell-free DNA (dd-cfDNA) test for assessing rejection and allograft injury in lung transplant patients.
The blinded prospective clinical validation, published in Transplant Direct, analyzed 195 biopsy-matched samples from 103 patients with cohort demographics that closely mirrored those reported to the Scientific Registry of Transplant Recipients (SRTR). Prospera Lung dd-cfDNA results were analyzed with various complications from lung transplantation, including acute rejection (AR, acute cellular rejection and antibody mediated rejection), chronic lung allograft dysfunction/neutrophilic-responsive allograft dysfunction (CLAD), and allograft infection (INFXN). The Prospera test exhibited notable performance data across all clinical events, including:
- AR vs. Stable; 0.91 AUC
- AR+CLAD+INFXN vs. Stable; 0.76 AUC
“These data are a promising demonstration of the value that the Prospera Lung dd-cfDNA test can provide in monitoring for lung transplant complications,” says Brian Keller, MD, PhD, associate professor of medicine at The Ohio State University Wexner Medical Center, and principal investigator of the study. “It is exciting to add the Prospera Lung dd-cfDNA test in our diagnostic toolbox as we strive to improve monitoring, treatment, and outcomes for these patients.”
As highlighted in the study, “…plasma dd-cfDNA is a promising precision biomarker in lung transplantation that can complement routine clinical assessments for evaluating lung allograft health.” Prospera Lung is already utilized in more than 20% of U.S. lung transplant centers and Natera continues to pursue further clinical evaluation and investigate the impact of Prospera Lung on patient outcomes in upcoming studies, including the multi-center randomized-controlled clinical trial, LAMBDA 001.
The Prospera test leverages Natera’s core single-nucleotide (SNP)-based massively multiplexed PCR (mmPCR) technology to identify allograft rejection non-invasively and with high precision and accuracy, without the need for prior donor or recipient genotyping.
The test works by measuring the fraction of donor-derived cell-free DNA (dd-cfDNA) in the recipient’s blood. It may be used by physicians considering the diagnosis of active rejection, helping to rule in or out this condition when evaluating the need for diagnostic testing or the results of an invasive biopsy.