PEDAL Study Successful, Shows Monitoring with Prospera™ Kidney Provides Accurate Prognosis of Long-Term Clinical Outcomes Following Rejection; Now Published in AJT

First prospective, multi-center trial to examine how dd-cfDNA can be used in post-rejection patient management

AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing and precision medicine, today announced that the American Journal of Transplantation published findings from the PEDAL study. PEDAL is the first prospective multi-center trial evaluating longitudinal trends of donor-derived cell-free DNA (dd-cfDNA) to determine the prognostic ability of Prospera in assessing outcomes following kidney transplant rejection.

PEDAL enrolled 488 kidney transplant recipients from 28 participating U.S. and international transplant centers over 4 years. 66 patients with biopsy-proven acute rejection (BPAR) were longitudinally tested with Prospera in the immediate eight-weeks following BPAR and clinical outcomes were recorded at 12-months. Results from the study demonstrated that Prospera dd-cfDNA trends post-rejection are strongly associated with and prognostic of one-year outcomes.

Key findings included:

• The odds of experiencing positive outcomes after 1 year were 60x higher among patients with low/decreasing Prospera trends. These patients were also 13x more likely to have resolving kidney dysfunction.
• Conversely, 97.5% (40/41) of cases with sustained elevated/high Prospera trends experienced negative clinical outcomes.
• Prospera trends were statistically associated with outcomes, suggesting dd-cfDNA may help physicians manage patients post-BPAR.

“Following a rejection episode, understanding the long-term prognosis and risk is critical in making ongoing treatment decisions for the patient,” said Suphamai Bunnapradist, M.D., professor of medicine at UCLA and principal investigator of the PEDAL study. “These findings make it clear that dd-cfDNA is an important non-invasive tool to provide more accurate risk stratification post-rejection that will enable more personalized patient management and improve long-term graft survival.”

“This study, the first prospective, multi-center trial to examine this use case, highlights how dynamic monitoring with Prospera provides critical information following a rejection event,” said Hossein Tabriziani, M.D., senior medical director of organ health and transplantation at Natera. “By leveraging Prospera, we can empower physicians to make more informed treatment decisions during the immediate post-rejection phase in kidney transplant management."

About Prospera

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.

About Natera

Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 300 peer-reviewed publications that demonstrate excellent performance. 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.

Forward-Looking Statements

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, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our 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.