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Natera Launches Quantification Technique to Enhance Prospera™ Test Precision; Initiates PEDAL Study for New Insights
Quantifying background cfDNA increases accuracy of dd-cfDNA testing SAN CARLOS, Calif., June 1, 2020 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a pioneer
About this update from Natera, Inc.
[{"type":"text","content":"Quantifying background cfDNA increases accuracy of dd-cfDNA testing\n\n\nSAN CARLOS, Calif., June 1, 2020 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, is pleased to announce the launch of a novel technique to enhance results from the Prospera donor-derived cell-free DNA (dd-cfDNA) transplant rejection assessment test, as well as a multi-site prospective study to externally validate an enhanced algorithm across multiple clinical indications. The PEDAL Study (Prospera Test Enhancement by Detecting Background Cell-Free DNA Levels) will include 500 kidney transplant patients from 20 major U.S. centers.\n\n \n \n \n \n \n \n\n \nNatera has processed more than two million cfDNA tests and leveraged its extensive dataset to conclude that elevated background cfDNA can result in artificially lower dd-cfDNA percentages. Based on its research, Natera now can quantify background cfDNA to more accurately identify those at risk of active rejection. The technique is performed routinely with the Prospera test in a single workflow, without increasing cost or lengthening run time. Details were presented at the American Transplant Congress (ATC), along with data for each of the major factors that impact the levels of background cfDNA. Several case studies of the technique are presented at ATC by leading physicians in the field.\n\"Natera is the first commercial laboratory to introduce this novel technique. We're pleased to leverage our scientific expertise in cfDNA to improve transplant rejection testing,\" said Steve Chapman, Natera's CEO. \"This innovation further separates the Prospera test from first generation dd-cfDNA tests.\"\nThe PEDAL Study will measure the performance of the Prospera test which measures dd-cfDNA and, most recently, background cfDNA. The three key objectives of the study involve: (1) further assessing the performance of the assay to detect rejection, (2) assessing the prognostic ability of cfDNA at the time of biopsy, and (3) assessing the performance of the assay to detect clearance of rejection after treatment. \"The PEDAL Study will give us deeper insight into the Prospera test's diagnostic capability and expand the clinical utility of dd-cfDNA testing,\" said Phil Gauthier, M.D., Natera's medical director of transplant. \"We're very pleased to be working with premie...