Includes new results from the ProActive study, reinforcing the utility of the Prospera™ Kidney test for ongoing surveillance of transplant rejection

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) and genetic testing, today announced that the company will present new data on its Prospera donor-derived cfDNA (dd-cfDNA) test at the American Transplant Congress (ATC) 2024 taking place June 1–5, 2024.

Natera and its collaborators will present 18 abstracts highlighting new Prospera data across heart, lung, kidney, and multi-organ transplantation. This includes an oral presentation highlighting the predictive capabilities of the Prospera Kidney test from the ProActive study, the largest prospective dd-cfDNA study in kidney transplant recipients.

“We look forward to sharing new research at ATC that demonstrates the breadth of clinical evidence supporting Prospera across multiple organ types,” said Sangeeta Bhorade, MD, chief medical officer of organ health at Natera. “This includes new data from the landmark ProActive study, reinforcing the value of the Prospera Kidney test as a highly accurate surveillance tool for detecting ongoing organ rejection and predicting future rejection.”

Highlights from selected abstracts include:

• Oral Presentation | Abstract # 362 | Presenter: Elliot Aguilar, PhD | June 2, 3:00 PM - 4:00 PM ET | Prospera Kidney
  
  Exploring Total and Donor Cell-Free DNA in Kidney Transplants: A Differential Rejection Analysis of Antibody Mediated and T-Cell Mediated Rejections
  
  
  
  Results from 1,022 kidney transplant patients enrolled in the ProActive study showed excellent performance of the Prospera Kidney test for predicting allograft rejection when combining clinical factors and key biomarkers with longitudinal testing, improving performance further (area under the curve range: 92-96%).

• Poster Presentation | Abstract # A172 | Presenter: Milagros Samaniego-Picota, MD | June 1, 5:30 - 7:00 PM ET | Prospera Kidney
  
  Clinically Significant Variation of dd-cfDNA in Kidney Transplant Recipients
  
  
  
  Results from 866 stable kidney transplant patients enrolled in the ProActive study show that a change of dd-cfDNA fraction of more than 72.9% between sequential results may indicate clinical significance and be especially useful for the interpretation of borderline results. Additionally, longitudinal variance within an individual supports the need for surveillance to establish baseline values.

• Poster Presentation | Abstract # C215 | Presenter: Suphamai Bunnapradist, MD, MS | June 3, 9:15 - 10:00 AM ET & 2:30 - 3:15 PM ET | Prospera Kidney
  
  Longitudinal dd-cfDNA trends and clinical outcomes in kidney transplant recipients
  
  
  
  Findings from 370 kidney transplant patients enrolled in the ProActive study suggest that dd-cfDNA trends may allow for the stratification of patients into different risk categories. Notably, dd-cfDNA levels consistently below 0.3% were associated with a low incidence of adverse outcomes. The likelihood of adverse events increased with additional elevations in dd-cfDNA.

• Poster Presentation | Abstract # A178 | Presenter: Hossein Tabriziani, MD, PhD | June 1, 5:30 - 7:00 PM ET | Prospera Kidney
  
  Is dd-cfDNA Prognostic for Future Kidney Allograft Rejection?
  
  
  
  In 452 kidney transplant patients, elevated dd-cfDNA at the time of a non-rejection biopsy was significantly associated with future allograft rejection, suggesting that patients with elevated dd-cfDNA should be considered at high risk for future rejection and monitored closely.

Additionally, Natera will host a lunch symposium on June 2nd from 12:15 - 1:15 PM ET titled, “Monitoring matters: Latest data supporting Prospera™ dd-cfdna for routine kidney transplant care.” It will include participation from Zahraa Hajjiri, MD, assistant professor of medicine, interim UNOS medical director, Transplant Nephrology, AST Transplant Nephrology Fellowship Director, University of Illinois-Chicago, Anil Chandraker, MD, professor of medicine, UMass Chan School of Medicine, chief, division of Renal Medicine, UMass Memorial Health Care, and Ali Zarrinpar, MD, PhD, professor, University of Florida College of Medicine, University of Florida Health.

The data being presented at ATC adds to the growing body of research supporting Natera’s organ health tests, which includes over 40 peer-reviewed publications.

About the Prospera test

The Prospera^TM 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^TM is a global leader in cell-free DNA testing 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 validated by more than 200 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.

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, or our expectations 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240530845740/en/