DEFINE-HT Selected for Late-Breaking Oral Presentation at ISHLT Annual Meeting
Natera (NASDAQ: NTRA) announced upcoming presentation of results from the DEFINE-HT study at the International Society for Heart and Lung Transplantation (ISHLT) 45th Annual Meeting on April 29, 2025. The study is the first prospective, multicenter trial evaluating the association between donor-derived cell-free DNA (dd-cfDNA) and clinical outcomes in heart transplant recipients using Prospera Heart with Donor Quantity Score (DQS).
The trial included over 1,100 dd-cfDNA tests, comparing Prospera testing with traditional rejection surveillance monitoring and endomyocardial biopsies for up to one year post-transplant. The research aims to determine if Prospera outperforms biopsy in predicting graft dysfunction and whether its proprietary two-threshold algorithm shows stronger correlation with clinical outcomes than dd-cfDNA percentage alone.
Natera (NASDAQ: NTRA) ha annunciato la prossima presentazione dei risultati dello studio DEFINE-HT durante il 45° Congresso Annuale della Società Internazionale per il Trapianto di Cuore e Polmoni (ISHLT), previsto per il 29 aprile 2025. Lo studio è il primo trial prospettico e multicentrico che valuta l'associazione tra il DNA libero da cellule derivate da donatore (dd-cfDNA) e gli esiti clinici nei riceventi di trapianto cardiaco utilizzando Prospera Heart con Donor Quantity Score (DQS).
Il trial ha incluso oltre 1.100 test di dd-cfDNA, confrontando il test Prospera con il monitoraggio tradizionale del rigetto e le biopsie endomiocardiche fino a un anno dopo il trapianto. La ricerca mira a determinare se Prospera superi la biopsia nella previsione della disfunzione del trapianto e se il suo algoritmo proprietario a due soglie mostri una correlazione più forte con gli esiti clinici rispetto alla percentuale di dd-cfDNA da sola.
Natera (NASDAQ: NTRA) anunció la próxima presentación de los resultados del estudio DEFINE-HT en la 45ª Reunión Anual de la Sociedad Internacional de Trasplante de Corazón y Pulmón (ISHLT) el 29 de abril de 2025. El estudio es el primer ensayo prospectivo y multicéntrico que evalúa la asociación entre el ADN libre de células derivado de donantes (dd-cfDNA) y los resultados clínicos en receptores de trasplante de corazón utilizando Prospera Heart con Donor Quantity Score (DQS).
El ensayo incluyó más de 1,100 pruebas de dd-cfDNA, comparando la prueba Prospera con la vigilancia tradicional del rechazo y las biopsias endomiocárdicas hasta un año después del trasplante. La investigación tiene como objetivo determinar si Prospera supera a la biopsia en la predicción de la disfunción del injerto y si su algoritmo propietario de dos umbrales muestra una correlación más fuerte con los resultados clínicos que el porcentaje de dd-cfDNA por sí solo.
Natera (NASDAQ: NTRA)는 2025년 4월 29일 국제심장폐이식학회(ISHLT) 제45회 연례 회의에서 DEFINE-HT 연구 결과 발표를 예정하고 있다고 발표했습니다. 이 연구는 기증자 유래 세포 자유 DNA(dd-cfDNA)와 심장 이식 수혜자의 임상 결과 간의 연관성을 평가하는 첫 번째 전향적 다기관 시험입니다. Prospera Heart와 Donor Quantity Score(DQS)를 사용합니다.
이 시험은 1,100건 이상의 dd-cfDNA 테스트를 포함하여 Prospera 테스트와 전통적인 거부 감시 모니터링 및 심근 생검을 이식 후 최대 1년까지 비교했습니다. 연구의 목적은 Prospera가 생검보다 이식 기능 장애를 예측하는 데 더 우수한지, 그리고 그 독점적인 두 개의 임계값 알고리즘이 dd-cfDNA 비율 단독보다 임상 결과와 더 강한 상관관계를 보여주는지를 확인하는 것입니다.
Natera (NASDAQ: NTRA) a annoncé la prochaine présentation des résultats de l'étude DEFINE-HT lors de la 45e Réunion Annuelle de la Société Internationale de Transplantation de Cœur et de Poumon (ISHLT) prévue pour le 29 avril 2025. Cette étude est le premier essai prospectif multicentrique évaluant l'association entre l'ADN libre de cellules dérivé de donneur (dd-cfDNA) et les résultats cliniques chez les receveurs de greffe cardiaque utilisant Prospera Heart avec Donor Quantity Score (DQS).
L'essai a inclus plus de 1 100 tests de dd-cfDNA, comparant le test Prospera avec la surveillance traditionnelle du rejet et les biopsies endomyocardiques pendant jusqu'à un an après la greffe. La recherche vise à déterminer si Prospera surpasse la biopsie dans la prédiction de la dysfonction du greffon et si son algorithme propriétaire à deux seuils montre une corrélation plus forte avec les résultats cliniques que le pourcentage de dd-cfDNA seul.
Natera (NASDAQ: NTRA) kündigte die bevorstehende Präsentation der Ergebnisse der DEFINE-HT-Studie auf dem 45. Jahreskongress der International Society for Heart and Lung Transplantation (ISHLT) am 29. April 2025 an. Die Studie ist die erste prospektive, multizentrische Studie, die den Zusammenhang zwischen donor-abgeleitetem zellfreiem DNA (dd-cfDNA) und klinischen Ergebnissen bei Herztransplantationsempfängern unter Verwendung von Prospera Heart mit Donor Quantity Score (DQS) bewertet.
Die Studie umfasste über 1.100 dd-cfDNA-Tests, die den Prospera-Test mit der traditionellen Überwachung von Abstoßungsreaktionen und endomyokardialen Biopsien bis zu einem Jahr nach der Transplantation verglichen. Die Forschung zielt darauf ab zu bestimmen, ob Prospera bei der Vorhersage von Transplantationsdysfunktion besser abschneidet als Biopsien und ob ihr proprietärer Algorithmus mit zwei Schwellenwerten eine stärkere Korrelation mit klinischen Ergebnissen zeigt als der dd-cfDNA-Anteil allein.
- First-of-its-kind prospective multicenter study that could validate Prospera Heart's clinical utility
- Large-scale trial with over 1,100 dd-cfDNA tests conducted
- Potential to demonstrate superior performance over traditional biopsy methods
- None.
Insights
Natera's DEFINE-HT study selection for a late-breaking presentation at ISHLT represents a potentially important development in heart transplant monitoring. The study investigates whether donor-derived cell-free DNA (dd-cfDNA) levels measured by Prospera Heart with DQS correlate with adverse clinical outcomes - a fundamental question for non-invasive transplant monitoring.
What makes this study noteworthy is its prospective, multicenter design with over
The study also evaluates Natera's proprietary two-threshold algorithm that combines dd-cfDNA percentage with their Donor Quantity Score. If validated, this approach could potentially offer superior risk stratification compared to single-threshold dd-cfDNA monitoring.
Selection as a late-breaking presentation suggests the findings may be significant, as these slots are typically reserved for studies with meaningful clinical implications. However, without actual results disclosed, it's premature to assess the true clinical impact. The transplant community will be watching closely to determine whether this technology could reduce reliance on invasive biopsies while maintaining or improving early detection of rejection events.
This announcement represents a milestone in Natera's strategy to expand its Prospera transplant monitoring portfolio beyond kidneys into the heart transplant space. The DEFINE-HT study directly addresses two critical questions that influence clinical adoption: whether dd-cfDNA testing correlates with actual patient outcomes and whether it can potentially reduce reliance on invasive biopsies.
From a commercial perspective, the selection for a late-breaking presentation at ISHLT is moderately positive as these slots are typically reserved for studies with potentially practice-changing results. However, the actual commercial impact depends entirely on the study findings, which remain undisclosed until April 29.
The heart transplant diagnostic monitoring market represents a smaller but strategic opportunity for Natera compared to kidney transplantation (approximately
Investors should recognize that while positive study results would support clinical adoption, the path to revenue generation still requires favorable reimbursement decisions and clinician acceptance. The proprietary two-threshold algorithm could potentially differentiate Natera's offering if validated, but the true impact on Natera's financial performance remains to be determined pending the actual study findings.
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)
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
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250325331714/en/
Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350, investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com
Source: Natera, Inc.
FAQ
What is the significance of the DEFINE-HT study for NTRA's Prospera Heart test?
How many dd-cfDNA tests were performed in NTRA's DEFINE-HT study?
When will NTRA present the DEFINE-HT study results?
What advantages could Prospera Heart with DQS offer over traditional biopsies?
