SAN CARLOS, Calif., Jan. 14, 2021 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA (cfDNA) testing, today announced it will present new data on the Prospera test at the American Society of Transplant Surgeons (ASTS) 21st Annual Winter Symposium, taking place January 14-16, 2021.
Natera will present five posters, featuring case studies that detail the use of the Prospera test to detect active rejection and injury of kidney transplants.
"Donor-derived cfDNA testing is becoming an increasingly powerful tool to better assess kidney transplant rejection, and I’m delighted to collaborate with Natera, who is at the forefront of this research," said Dr. Obi Ekwenna, MD, FACS, Transplant Surgeon at the University of Toledo Medical Center, and first author of two of the studies to be presented. "In our studies, we show that serial testing with the Prospera test provides valuable information about allograft health, and enables transplant providers and nephrologists to better manage patients and reduce the risk of graft failure."
Details about the abstracts are as follows:
Abstract # 2020-A-151-ASTS | Poster Presentation
Presenter: Obi Ekwenna, MD, FACS
Elevated donor-derived cell-free DNA in patients with delayed graft function
We present a retrospective study of Prospera test results in 16 kidney transplant recipients who developed delayed graft function (DGF). 56.2% of them had elevated donor-derived cfDNA (dd-cfDNA) levels at the first blood draw following transplant with a mean dd-cfDNA of 1.32%. Persistently elevated dd-cfDNA levels were associated with prolonged DGF, while decreasing levels were associated with resolution of DGF, suggesting that dd-cfDNA dynamics over time can potentially serve as a predictive marker for resolution of DGF.
Abstract # 2020-A-135-ASTS | Poster Presentation
Presenter: Obi Ekwenna, MD, FACS
Serial testing with donor-derived cell-free DNA test to monitor dual and en bloc kidney transplants for active rejection
This is a case series of nine patients who have undergone dual or en bloc kidney transplants. In both of these clinical scenarios, increased allograft volume or other factors not yet defined may contribute to increased basal levels of dd-cfDNA. This study demonstrates the utility of serial monitoring with the Prospera test, starting early in the clinical course of the recipient, to better surveil renal allografts.
Abstract # 2020-A-52-ASTS | Poster Presentation
Presenter: Mark Fajardo, MHA, BSN, RN
Assessment of donor-derived cell-free DNA for allograft rejection in kidney transplant patients and its incorporation into clinical practice
This abstract is a real-world clinical experience study describing the use of the Prospera test in more than 1,000 kidney transplant recipients. Renal allograft biopsies performed within two weeks of a positive Prospera test result showed active rejection 64.3% of the time, which is a considerably higher rate than is seen with other rejection biomarkers and superior to what is described in previously published validation studies in patient populations at average risk of rejection, indicating that physicians are using dd-cfDNA to make better decisions around biopsy.
Abstract # 2020-A-142-ASTS | Poster Presentation
Presenter: David Ono, MD
Clinical utility of donor-derived cell-free DNA testing for allograft rejection in patients with limited access to biopsy
We present a retrospective analysis of four cases where serial dd-cfDNA testing was used to remotely monitor kidney transplant rejection as an alternative to biopsy. In all cases, dd-cfDNA levels were consistent with biopsy results or physician assessment of rejection status, highlighting the clinical utility of the Prospera test in patients with limited access to biopsy.
Abstract # 2020-A-131-ASTS | Poster Presentation
Presenter: Prince Mohan, MD
Anti-rejection therapies in renal transplant patients may influence background cell-free DNA, impacting the quantification of donor-derived cell-free DNA
This is a case study of a kidney transplant recipient who was serially monitored with the Prospera test while on anti-rejection therapy. The patient had a sudden decrease in dd-cfDNA levels, with a simultaneous increase in host-derived background cfDNA, which coincided with administration of anti-rejection therapy. These data suggest the patient’s immunosuppressive therapy may influence the dd-cfDNA fraction and potentially impact dd-cfDNA results, thus highlighting the importance of longitudinal monitoring with independent assessment of dd-cfDNA and background cfDNA.
In addition to the poster presentations, Natera will be sponsoring a number of virtual sessions with several key transplant leaders. For more information, visit: natera.com/organ-health/asts-2021.
About the Prospera 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 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. The Prospera test 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.
Natera is a pioneer and global leader in cell-free DNA testing from a simple blood draw. The mission of the company is to change the management of disease worldwide with a focus on women’s health, oncology, and organ health. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, California and Austin, Texas. 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.
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