Natera Announces Data from the ProActive Study that Supports Prospera™ Kidney as an Early Indicator of Transplant Rejection

AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced new data on its Prospera test being presented at the American Transplant Congress (ATC) 2023 taking place June 3-7, 2023. The presentations include several interim analyses from ProActive, a prospective donor-derived cell-free DNA (dd-cfDNA) study evaluating Natera’s Prospera test for the detection of rejection in kidney transplant patients, as well as additional presentations that showcase the utility of Prospera in kidney and heart transplantation. The Company’s presence at ATC includes three oral presentations, several posters, and a symposium led by medical experts in kidney transplantation.

“We’re excited to unveil new data at ATC that reinforces dd-cfDNA as a leading indicator of transplant rejection,” said Suphamai Bunnapradist, MD, MS, professor of medicine, David Geffen School of Medicine at UCLA. “The ProActive study demonstrates that Prospera Kidney provides highly accurate and early insight into allograft health using a non-invasive tool. I’m optimistic that this study will help transform the current standard of care for patients with kidney transplants by optimizing the management of these patients to improve long-term outcomes.”

Key highlights from the ProActive Study interim analyses presented at ATC included:

• Prospera Kidney dd-cfDNA predicted ABMR up to four months, and TCMR up to two months, in advance of biopsy-proven rejection, underscoring the value of Prospera.
• 86.9% of stable kidney transplant recipients had dd-cfDNA persistently below 1%, further supporting Prospera as a reliable indicator of allograft stability.
• Patients with biopsy-proven rejection showed a 60X median elevation in dd-cfDNA% vs baseline, compared to just 1.3X median elevation in the non-rejection group, indicating that Prospera may allow for real-time prediction of rejection risk through continuous monitoring of dd-cfDNA level changes.

“We’re proud to be leading such impactful studies in kidney transplantation and to be presenting findings from these studies with our esteemed partners at ATC this year,” said Sangeeta Bhorade, MD, chief medical officer of organ health at Natera. “Our data presentations further support the use of the Prospera test as a reliable, non-invasive tool that outperforms other standard clinical markers. We look forward to publishing data from the ProActive study and sharing additional readouts from our studies in the future.”

The complete list of Natera’s presentations at ATC is as follows:

• Industry Symposium | Prospera Kidney | ProActive Study
  • How New Data Supports dd-cfDNA as a Prognostic Biomarker for Earlier Kidney Rejection Assessment

Participation from Daniel C. Brennan, MD, FACP, professor of medicine, medical director, Comprehensive Transplant Center of The Johns Hopkins University School of Medicine; Jonathan Bromberg, MD, PhD, vice chair for research, Department of Surgery at the University of Maryland; and Matthew Cooper, MD, FACS, FAST, chief, Transplant Surgery and director of Solid Organ Transplantation at Medical College of Wisconsin.

• Oral Presentation | Prospera Kidney | ProActive Study
  • P84: Increases In Donor-Derived Cell-Free DNA Prior to Biopsy-Proven Rejection In Kidney Transplant
• Poster Presentation | Prospera Kidney | ProActive Study
  • C143: Donor Derived cfDNA Fraction Levels in Stable Kidney Transplant Recipients in the First Year After Transplant
• Poster Presentation | Prospera Kidney | ProActive Study
  • C165: Increases from Baseline dd-cfDNA Fraction are Associated with Acute Allograft Rejection in Kidney Transplant Recipients
• Poster Presentation | Prospera Kidney | ProActive Study
  • C139: Performance of Donor-Derived Cell-Free DNA in Repeat Kidney Transplant Recipients
• Oral Presentation | Prospera Kidney
  • P87: Three-way Comparison of Central DSA, % dd-cfDNA, and Molecular Biopsy Findings in Trifecta-Kidney: New Analyses in an Expanded Population of 605 Biopsies
• Oral Presentation | Prospera Heart
  • P29: Correlation of Plasma Cell-free DNA with Molecular Rejection in Heart Transplant Biopsies
• Poster Presentation | Prospera Heart
  • B294: Association between Donor-Derived Cell-Free DNA and Donor-Specific Antibodies and Impact on Graft Management: A Clinical Experience Study
• Poster Presentation | Prospera Kidney
  • D168: Multiple Processes Determine Donor-derived Cell-Free DNA Release from Kidney Transplants in ABMR, TCMR, and Injury
• Poster Presentation | Prospera Kidney
  • C163: Clinical Utility of dd-cfDNA in Assessing Incomplete Recovery of Kidney Function After Transplantation

All abstracts can be found on the ATC website here.

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. It 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.

About Natera

Natera™ is a global leader in cell-free DNA 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 100 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.

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