Natera launches improved donor-derived cell-free DNA test for kidney graft rejection
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Natera Inc. has launched the latest version of its test for allograft rejection following kidney transplantation, which now provides the quantity of donor-derived cell-free DNA in addition to the donor-derived cell-free DNA fraction alone.
The test, known as Prospera with Quantification, is the only available cell-free DNA (cfDNA) test for kidney rejection that provides three values (quantity, fraction and total cfDNA) on every report, according to a press release.
“Total cell-free DNA is often elevated during viral infections and other complicated scenarios due to increases in the host-derived fraction. Consequently, the percentage of [donor-derived] dd-cfDNA can be artificially depressed in these scenarios, leading to false negative results,” Suphamai Bunnapradist, MD, transplant nephrologist at the University of California, Los Angeles (UCLA), said in the release. “The absolute quantification of dd-cfDNA in the sample is a game-changer as it makes the test more robust in challenging clinical scenarios, while boosting its sensitivity.”
Bunnapradist served as senior author on a paper, published in the Journal of the American Society of Nephrology, which investigated the performance of the test.
That study, which included 41 patients undergoing allograft management at the UCLA Medical Center, showed the two-threshold algorithm (assessing quantity of dd-cfDNA in addition to dd-cfDNA fraction) improved sensitivity compared with the original method; specifically, sensitivity improved from 77.8% to 100%. Although results demonstrated a minimal decline in specificity (from 90.6% to 87.5%), the researchers contended the two-threshold algorithm “holds promise for improved sensitivity in the detection of [acute rejection] AR in renal allograft patients while maintaining high specificity.”
Findings from Trifecta, a “large, international multisite prospective study” evidencing the clinical utility and increase in sensitivity achieved by Prospera with Quantification, are expected to be published early in 2022, according to the release.
References:
- Bunnapradist S, et al. J Am Soc Nephrol. 2021;doi:10.1681/ASN.2021050645.
- Natera Launches Prosper kidney with Quantification to further improve test performance, demonstrating commitment to innovation in transplantation. https://www.natera.com/company/news/natera-launches-prospera-kidney-with-quantification-to-further-improve-test-performance-demonstrating-commitment-to-innovation-in-transplantation. Published Sept. 9, 2021. Accessed Sept. 17, 2021.