First-of-its-kind prospective trial evaluates the association between dd-cfDNA and clinical outcomes in heart transplantation using Prospera™ Heart with Donor Quantity Score (DQS)

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, announced that it will share results from the DEFINE-HT study in a late-breaking oral presentation at the International Society for Heart and Lung Transplantation (ISHLT) 45th Annual Meeting on April 29, 2025.

DEFINE-HT is the first prospective, multicenter study in heart transplant recipients designed to assess whether elevated levels of donor-derived cell-free DNA (dd-cfDNA), as measured by Prospera Heart with DQS, are associated with adverse clinical outcomes. Following heart transplant, Prospera testing was performed concurrently with rejection surveillance monitoring, including endomyocardial biopsies (EMB), for up to one year. The trial included over 1,100 dd-cfDNA tests.

The analysis also explores whether Prospera outperforms biopsy in predicting graft dysfunction. In addition, the study evaluates whether Prospera’s proprietary two-threshold algorithm, which combines dd-cfDNA % and DQS, demonstrates stronger correlation with clinical outcomes than dd-cfDNA % alone.

“The DEFINE-HT study is the first of its kind to address whether dd-cfDNA is predictive of clinical outcomes and can help risk-stratify patients for personalized management after heart transplantation,” said Palak Shah, M.D., M.S., national principal investigator for DEFINE-HT, director of the Inova Cardiovascular Genomics Center, and medical director of mechanical circulatory support at Inova Fairfax Medical Campus. “This study establishes a foundation for further investigation into how dd-cfDNA surveillance compares with biopsy post-transplant.”

“DEFINE-HT has the potential to offer valuable context for interpreting dd-cfDNA results in clinical practice,” said Sangeeta Bhorade, M.D., chief medical officer of organ health at Natera. “Understanding how Prospera Heart with DQS aligns with outcomes could enhance clinical decision-making and support more individualized care for transplant patients.”

In total, Natera and its research collaborators will present 10 datasets in heart and lung transplantation at ISHLT, including oral and poster presentations.

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 validated by more than 250 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, 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.

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