Represents largest dd-cfDNA retransplant study to date and demonstrates clinical value of proprietary background cfDNA technology
SAN CARLOS, Calif., Oct. 21, 2020 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced it will present new data at the 2020 American Society of Nephrology (ASN) Kidney Week virtual meeting taking place October 22-25, 2020. The presentations will showcase the performance of the Prospera test in patients with a second kidney transplant and will highlight the differentiated clinical value in patients with COVID-19 or other viral infections.
Natera will share new data on the largest study performed in patients who have received a second kidney transplant. The results show a significant difference in the donor-derived cell-free DNA (dd-cfDNA) between active rejection and non-active rejection patients, demonstrating performance consistent with published performance in first transplant patients.
Additionally, Natera will present new clinical results on its novel technique to quantify background cfDNA which could provide significant clinical value for patients who may have COVID-19 or other viral infections, further differentiating the Prospera test from first-generation dd-cfDNA tests.
"These studies can help us gain a deeper understanding of how dd-cfDNA-based kidney transplant rejection tests perform in different patient populations — particularly those infected by viral pathogens, including COVID-19 — and are critical to their adoption in clinical practice," said Suphamai Bunnapradist, MD, MS, nephrologist at Ronald Reagan Medical Center at UCLA and co-author of two of the studies to be presented.
Details about the abstracts are as follows:
Abstract #PO2394 | Poster Presentation
Presenter: Phil Gauthier, MD
Development and clinical experience with a cfDNA monitoring algorithm for kidney retransplants
This study evaluates the clinical performance of the algorithm used by the Prospera test in patients who have received a second kidney transplant. Significantly elevated dd-cfDNA levels in patients with active rejection suggest that the Prospera test can be used to detect injury/rejection of a second transplanted organ.
Abstract #PO0792 | Poster Presentation
Presenter: Suphamai Bunnapradist, MD, MS
Case Study: Kidney transplant patient with COVID-19: Impact of viral infection on background cell-free DNA in a donor-derived cell-free DNA rejection assay
A case study of a kidney transplant recipient with severe COVID-19 infection that resulted in septic shock. The patient’s background cfDNA levels were extremely elevated (as high as ~57X the median value), possibly due to cell death/apoptosis due to immunological responses and/or tissue ischemia. The relationship between dd-cfDNA and background cfDNA demonstrates the importance of accurately measuring both of these metrics when testing patients with viral infection to accurately determine allograft health.
Abstract #PO2398 | Poster Presentation
Presenter: Suphamai Bunnapradist, MD, MS
Case Series: Systemic infection alters background cell-free DNA and influences results of donor-derived cell-free DNA transplant rejection assays
A study of three kidney transplant cases with elevated background cfDNA levels that are associated with viral infection. The findings from this study suggest dd-cfDNA levels may be confounded by elevated background cfDNA and that variability in background cfDNA levels should be considered when assessing allograft rejection. These cases highlight the value of serial monitoring of dd-cfDNA in kidney transplant recipients, during and after viral infection.
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 women’s health, oncology, and organ health. 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.
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. 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 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.
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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SOURCE Natera, Inc.