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Natera Validates Prospera™ With Quantification in Multi-Site, Prospective Trifecta Study
Study represents the largest prospective, fully biopsy-matched cohort of dd-cfDNA for kidney transplant recipients AUSTIN, Texas, Nov. 3, 2021 /PRNewswire/ --
About this update from Natera, Inc.
[{"type":"text","content":"Study represents the largest prospective, fully biopsy-matched cohort of dd-cfDNA for kidney transplant recipients\n\n\nAUSTIN, Texas, Nov. 3, 2021 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a leader in personalized genetic testing, today announced the initial results1 from the global, multi-site, prospective Trifecta study led by Phil Halloran, M.D., Ph.D., director, Alberta Transplant Applied Genomics Centre. \n\n \n \n \n \n \n \n\n \nThe Trifecta study was designed to assess the performance of donor-derived cell-free DNA (dd-cfDNA) and to evaluate the relationship between dd-cfDNA, donor-specific antibodies and molecular pathology. The initial analysis includes more than 300 sequential biopsy-matched samples, drawn between 2019 – 2021, with over 100 biopsy-confirmed rejections from more than 20 U.S. and international sites. This represents the largest prospective, fully biopsy-matched cohort evaluating dd-cfDNA for kidney transplant recipients and includes roughly twice as many biopsy-matched rejections than any previously published prospective study. \nIn the validation cohort, when differentiating rejection from non-rejection, Prospera with Quantification delivered an AUC of 0.81 using the 2019 BANFF criteria, and 0.89 using molecular pathology, as the standards for rejection. Recent studies have shown that molecular pathology may be more accurate in diagnosing the rejection status in kidney transplant biopsies and therefore may be a better way to measure true cfDNA test performance. \nThe Prospera test also showed an AUC of 0.91 for differentiating rejection vs. quiescence; however, because quiescence includes only the most stable of patients, and excludes patients with non-rejection pathology findings on biopsy, its utility in a real-world setting is limited. This analysis is similar in concept to that described in recent multi-modality assay validation publications.2,3\n\"These new data from the Trifecta study clearly demonstrate that Prospera with quantification can accurately predict rejection in kidney transplant recipients with indications for biopsy from a diverse population and is a useful tool for comprehensive evaluation of graft status,\" said Phil Halloran, M.D., Ph.D. \n\"The AUC of Prospera with Quantification in this multi-site, prospective study was excellent and confirms Natera's position as the cfDNA t...