AUSTIN, Texas, June 8, 2022
Includes oral presentation on Prospera test's two-threshold algorithm, showing the combination of donor quantity and donor fraction outperforms donor fraction alone
AUSTIN, Texas, June 8, 2022 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) testing, today announced that it has presented data on the clinical utility of the company's Prospera™ and Renasight™ tests in 14 sessions at the American Transplant Congress (ATC) 2022 meeting. This expands on the thirteen peer-reviewed papers that have been published over the last twelve months, demonstrating the strong performance of both assays.
Phil Halloran, M.D., Ph.D., director of the Alberta Transplant Applied Genomics Centre, presented new data on the latest findings of the global, multisite, prospective Trifecta study, "Combining fraction and estimated amount of dd-cfDNA to assess kidney transplant rejection using molecular diagnoses and histology." The study demonstrates that the new two-threshold algorithm for the Prospera test - including both dd-cfDNA fraction and quantity - performed better than dd-cfDNA percentage alone in detecting active rejection, with an AUC of 0.88 when compared against molecular biopsy assessment and 0.82 when compared against histological biopsy assessment. This analysis in the Trifecta study features 367 fully-biopsy-matched samples from the 22 participating clinics in the U.S. and Europe.
"The data presented at ATC, combined with other important studies, highlight Natera's dedication to innovation and continued leadership in testing for transplant rejection and genetic risks for kidney disease," said Sangeeta Bhorade, M.D., chief medical officer for organ health at Natera. "The evidence continues to support the use of Natera technology for aiding clinicians in making major care decisions for transplant patients."
Data from the Trifecta study was also presented in three other ATC sessions, and a full listing of Natera's scientific sessions and presence can be found at https://www.natera.com/events/prospera-conference/
About the Prospera test
The ProsperaTM 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. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.
About the Renasight test
The RenasightTM test is a germline genetic test that screens for hereditary causes of kidney disease. It is indicated for patients with diagnosed kidney disease and is run from a patient's blood or saliva sample. Providers can use the Renasight test to identify a genetic predisposition, clarify a clinical diagnosis, or identify the etiology of an unknown kidney disease to help inform medical management. Additionally, genetic counseling and familial testing can be offered based on the test result. The test has been developed and its performance characteristics determined by the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.
NateraTM is a global leader in cell-free DNA testing, dedicated to oncology, women's health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that help lead to longer, healthier lives. Natera's tests are validated by more than 100 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. For more information, visit www.natera.com.
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.
Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350
Media: Kate Stabrawa, Communications, Natera, Inc., 720-318-4080 [email protected]
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SOURCE Natera, Inc.