Natera, Inc., a global leader in cell-free DNA testing, announced the results of a large, real-world study confirming strong performance of its Prospera donor-derived cell-free DNA (dd-cfDNA) test in assessing rejection for kidney transplant patients.
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The study, published in Transplantation Proceedings, reports the real-world impact of dd-cfDNA on patient management in a multi-center, real-world clinical cohort, including 879 patients evaluated from 33 participating clinics. Eighteen of the 28 patients with biopsy-matched high-risk Prospera dd-cfDNA test results were confirmed to have active rejection, demonstrating a reported 64% positive predictive value (PPV). Further, six of the remaining 10 patients had borderline TCMR or other pathologic conditions consistent with other types of kidney injury. As summarized in the publication, “The data indicate that incorporating dd-cfDNA testing into practice may improve physician decision making regarding renal allograft recipients.”
“The Prospera dd-cfDNA test continues to solidify its role as an important tool for monitoring the graft health of transplant patients,” said Yasir Qazi, M.D., associate professor of clinical medicine and medical director of the kidney-pancreas transplant outreach and fellowship program at the Keck School of Medicine of USC, principal investigator and lead author of the study. “It was exciting to see a strong performance in real-world clinical settings across leading institutions.”
This study adds to the growing body of evidence supporting Prospera dd-cfDNA testing, including the Trifecta study, the largest prospective, biopsy-matched, multi-center study to date in the field of kidney transplantation, currently submitted for publication.
About the Prospera test
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. The Prospera test has been clinically and analytically validated for performance regardless of donor relatedness, rejection type, and clinical presentation. It has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test.