New research on background cell-free DNA to refine transplant rejection risk
SAN CARLOS, Calif., May 26, 2020 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced it will present new data on its Prospera donor-derived cell-free DNA (dd-cfDNA) transplant assessment test at the 2020 American Transplant Congress (ATC), being held virtually from May 30-June 1, 2020.
Natera's Medical Director of Organ Transplantation, Phil Gauthier, MD, MBA, will present a late breaking abstract on June 1, 2020 at 5:00 pm ET. The abstract is titled "Factors influencing background cell-free DNA levels: implications for donor-derived cell-free DNA assessment in transplant patients."
Natera will also host a sponsored satellite symposium titled "Expanding our Expertise: Technological advancements in cfDNA to refine transplant rejection risk" on June 1, 2020 at 12:25 pm ET, featuring presentations by several leading transplant physicians and nephrologists:
Introducing the PEDAL Study: Prospera Enhancement by Detecting Background cell-free DNA Levels
- Daniel C. Brennan, MD, FACP; Professor of Medicine, Division of Nephrology, Johns Hopkins University School of Medicine and Medical Director, The Comprehensive Transplant Center
- Suphamai Bunnapradist, MD, MS; Transplant Nephrologist & Professor of Medicine, University of California Los Angeles (UCLA)
Trifecta Study: Calibrating Natera dd-cfDNA assay against the Molecular Microscope® Diagnostic System (MMDx)
- Phil Halloran, MD, PhD; Professor, Department of Medicine, University of Alberta, Edmonton, Canada and Director, Alberta Transplant Applied Genomics Centre
Prospera: Quantifying background cell-free DNA for enhanced performance
- Phil Gauthier, MD, MBA; Medical Director of Organ Transplantation, Natera, Inc.
"Natera has performed over two million cfDNA tests to date and has more than 25 published papers on cfDNA," said Paul Billings, MD, PhD, Natera's Chief Medical Officer and SVP of Medical Affairs. "We are excited to share our new research at this year's virtual ATC conference alongside several distinguished members of the transplant medical community."
About the Prospera dd-cfDNA Organ Transplant 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 this condition in or out when evaluating the need for further diagnostic testing or an invasive biopsy. Prospera has been clinically and analytically validated for performance regardless of donor relatedness, rejection type, and clinical presentation. Prospera 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 US Food and Drug Administration (FDA). Although FDA is exercising enforcement discretion of premarket review and other FDA legal requirements for laboratory-developed tests in the US, certification of the laboratory is required under CLIA to ensure the quality and validity of the tests
Natera is a global leader in cell-free DNA testing. The mission of the company is to change the management of disease worldwide with a focus on reproductive health, oncology, and organ transplantation. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. Follow Natera on LinkedIn.
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 our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, 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., 650-249-9090
Media: Paul Greenland, VP of Corporate Marketing, Natera, Inc., firstname.lastname@example.org
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