CareDx Launches Two Expanded Indications for AlloSure Testing Services
CareDx (CDNA) has announced two major expansions for its AlloSure® testing services. The first expansion extends AlloSure Heart testing to pediatric heart transplant patients under 15 years old, including infants. Studies show the test can detect rejection types ACR and AMR in pediatric patients, with one study demonstrating an 81% reduction in surveillance biopsies.
The second expansion validates AlloSure Kidney for simultaneous pancreas-kidney (SPK) transplant patients. Both expansions have received approval from the New York State Clinical Laboratory Evaluation Program. The kidney test helps differentiate patients at increased rejection risk from those with low rejection likelihood.
These expansions address significant market opportunities, considering that over 4,500 heart transplants were performed in the U.S. in 2024 (10% under age 18) and more than 700 patients received SPK transplants in the same year.
CareDx (CDNA) ha annunciato due importanti espansioni per i suoi servizi di test AlloSure®. La prima espansione estende il test AlloSure Heart ai pazienti pediatrici sottoposti a trapianto di cuore con meno di 15 anni, compresi i neonati. Gli studi dimostrano che il test può rilevare i tipi di rigetto ACR e AMR nei pazienti pediatrici, con uno studio che ha mostrato una riduzione dell'81% nelle biopsie di sorveglianza.
La seconda espansione convalida AlloSure Kidney per i pazienti sottoposti a trapianto simultaneo di pancreas e rene (SPK). Entrambe le espansioni hanno ricevuto l'approvazione dal Programma di Valutazione dei Laboratori Clinici dello Stato di New York. Il test renale aiuta a differenziare i pazienti a rischio elevato di rigetto da quelli con bassa probabilità di rigetto.
Queste espansioni affrontano significative opportunità di mercato, considerando che nel 2024 sono stati eseguiti oltre 4.500 trapianti di cuore negli Stati Uniti (il 10% sotto i 18 anni) e più di 700 pazienti hanno ricevuto trapianti SPK nello stesso anno.
CareDx (CDNA) ha anunciado dos importantes expansiones para sus servicios de pruebas AlloSure®. La primera expansión amplía las pruebas de AlloSure Heart a pacientes pediátricos de trasplante de corazón menores de 15 años, incluidos los bebés. Los estudios muestran que la prueba puede detectar los tipos de rechazo ACR y AMR en pacientes pediátricos, con un estudio que demuestra una reducción del 81% en las biopsias de vigilancia.
La segunda expansión valida AlloSure Kidney para pacientes de trasplante simultáneo de páncreas y riñón (SPK). Ambas expansiones han recibido aprobación del Programa de Evaluación de Laboratorios Clínicos del Estado de Nueva York. La prueba renal ayuda a diferenciar a los pacientes con mayor riesgo de rechazo de aquellos con baja probabilidad de rechazo.
Estas expansiones abordan oportunidades de mercado significativas, considerando que en 2024 se realizaron más de 4,500 trasplantes de corazón en EE. UU. (el 10% menores de 18 años) y más de 700 pacientes recibieron trasplantes de SPK en el mismo año.
CareDx (CDNA)는 AlloSure® 테스트 서비스의 두 가지 주요 확장을 발표했습니다. 첫 번째 확장은 15세 미만의 소아 심장 이식 환자, 즉 영아를 포함한 환자에게 AlloSure Heart 테스트를 확대하는 것입니다. 연구에 따르면 이 테스트는 소아 환자에서 ACR 및 AMR 유형의 거부 반응을 감지할 수 있으며, 한 연구에서는 감시 생검을 81% 줄일 수 있음을 보여주었습니다.
두 번째 확장은 동시 췌장-신장(SPK) 이식 환자에 대해 AlloSure Kidney의 유효성을 검증합니다. 두 가지 확장 모두 뉴욕주 임상 실험실 평가 프로그램의 승인을 받았습니다. 신장 테스트는 거부 위험이 높은 환자와 낮은 환자를 구분하는 데 도움을 줍니다.
이러한 확장은 2024년에 미국에서 4,500건 이상의 심장 이식이 수행되었고 (10%가 18세 미만) 700명 이상의 환자가 같은 해에 SPK 이식을 받았다는 점을 고려할 때, 중요한 시장 기회를 다루고 있습니다.
CareDx (CDNA) a annoncé deux grandes expansions pour ses services de test AlloSure®. La première expansion étend le test AlloSure Heart aux patients pédiatriques transplantés cardiaques de moins de 15 ans, y compris les nourrissons. Des études montrent que le test peut détecter les types de rejet ACR et AMR chez les patients pédiatriques, une étude démontrant une réduction de 81% des biopsies de surveillance.
La deuxième expansion valide AlloSure Kidney pour les patients ayant subi une transplantation simultanée de pancréas et de rein (SPK). Les deux expansions ont reçu l'approbation du Programme d'Évaluation des Laboratoires Cliniques de l'État de New York. Le test rénal aide à différencier les patients à risque accru de rejet de ceux ayant une faible probabilité de rejet.
Ces expansions répondent à d'importantes opportunités de marché, considérant qu'en 2024, plus de 4 500 transplantations cardiaques ont été réalisées aux États-Unis (10 % de moins de 18 ans) et plus de 700 patients ont reçu des transplantations SPK la même année.
CareDx (CDNA) hat zwei wichtige Erweiterungen seiner AlloSure® Testdienste angekündigt. Die erste Erweiterung erweitert den AlloSure Heart Test auf pädiatrische Herztransplantationspatienten unter 15 Jahren, einschließlich Säuglingen. Studien zeigen, dass der Test die Ablehnungsarten ACR und AMR bei pädiatrischen Patienten erkennen kann, wobei eine Studie eine Reduktion der Überwachungsbiopsien um 81% demonstriert.
Die zweite Erweiterung validiert AlloSure Kidney für Patienten mit gleichzeitigen Pankreas-Nieren-Transplantationen (SPK). Beide Erweiterungen haben die Genehmigung des Clinical Laboratory Evaluation Program des Bundesstaates New York erhalten. Der Nierentest hilft, Patienten mit erhöhtem Ablehnungsrisiko von solchen mit geringer Ablehnungslikelihood zu unterscheiden.
Diese Erweiterungen sprechen bedeutende Marktchancen an, da im Jahr 2024 in den USA über 4.500 Herztransplantationen durchgeführt wurden (10% unter 18 Jahren) und mehr als 700 Patienten im selben Jahr SPK-Transplantationen erhielten.
- Expansion into pediatric heart transplant market increases addressable patient population
- Clinical validation showing 81% reduction in invasive biopsies demonstrates strong product efficacy
- Entry into SPK transplant segment opens new revenue stream
- Regulatory approval from NY State validates test reliability
- None.
Insights
CareDx's expansion of AlloSure testing services represents a strategic market extension into two valuable specialized segments. The validation for pediatric heart transplant patients under 15 years old and for simultaneous pancreas-kidney (SPK) transplant recipients strengthens the company's comprehensive transplant diagnostics portfolio.
The clinical validation by the New York State Clinical Laboratory Evaluation Program carries significant regulatory weight, suggesting strong scientific evidence supports these expanded indications. The 81% reduction in surveillance endomyocardial biopsies demonstrated in pediatric populations represents meaningful clinical value and cost savings for healthcare systems.
Quantitatively, this expansion addresses approximately 450 additional pediatric heart transplant patients annually (10% of 4,500 U.S. heart transplants) and 700 SPK transplant patients. While these populations are relatively small, they represent high-value diagnostic opportunities with minimal additional development costs since they leverage existing technology.
The physician testimonials indicate strong clinical adoption potential, particularly the statement that surveillance biopsies are now considered "outdated" compared to AlloSure monitoring. This positions CareDx to potentially capture significant market share in these niches while strengthening its leadership in transplant diagnostics.
The revenue impact, while not immediately transformative given the patient population size, should contribute to incremental growth while reinforcing CareDx's positioning as "The Transplant Company™" with the most comprehensive diagnostic solutions across the transplant spectrum.
AlloSure Heart is Now Validated and Commercially Available for Pediatric Heart Transplant Patients Under 15
AlloSure Kidney is Now Validated and Commercially Available for Simultaneous Pancreas-Kidney Transplant Patients
Both indications are approved by the
AlloSure Heart, available for patients aged 15 years and older since 2020, is now clinically validated and commercially available for use in pediatric patients under 15, including infants. Studies have shown that AlloSure Heart can detect biopsy proven Acute Cellular Rejection (ACR) and AMR (Antibody Mediated Rejection) in all ages of pediatric heart transplant patients, consistent with its performance in adults.1-4 In a prospective study, the use of AlloSure dd-cfDNA for surveillance monitoring in pediatrics demonstrated an
"The availability of AlloSure dd-cfDNA for all pediatric heart transplant patients is a major development. Our goal is for every one of our patients, including our youngest heart transplant recipients, to thrive with their transplanted heart. With molecular surveillance we can monitor organ health while avoiding the inconvenience and discomfort of unnecessary biopsies,” said Dr. Brian Feingold, Medical Director, Pediatric Heart Transplantation, UPMC Children’s Hospital of
Simultaneous pancreas-kidney (SPK) transplants are known to improve the quality of life and long-term survival of patients with insulin dependent diabetes and advanced renal disease.5 As with other organ transplants, the organs are at risk of rejection. AlloSure Kidney has been clinically validated to identify rejection and graft injury in SPK patients.6-7 AlloSure Kidney can improve the management of SPK patients by differentiating those at increased risk of rejection, who are otherwise stable, from patients at low likelihood of rejection.
“It is an honor to have led some of the early studies and to see that AlloSure Kidney is now clinically validated and commercially available for use in patients who have undergone simultaneous pancreas-kidney transplantation,” said Dr. Dolamu Olaitan, MBBS, Transplant Surgeon, Rush University Medical Center. “I have witnessed firsthand the significant benefits for patients with diabetes and kidney failure of receiving a pancreas and kidney transplant. Now, we have a well-validated, non-invasive tool to monitor organ rejection and injury, which has the potential to improve their quality of life and long-term outcomes.”
"We are thrilled to introduce two new expanded indications of AlloSure, addressing critical needs in transplant patient care. Until now, children under 15 who received a heart transplant could only be tested by exception, but now they can receive routine AlloSure Heart testing. Additionally, for patients who have undergone a simultaneous pancreas-kidney transplant, we have a solution to meet their needs,” said Robert N. Woodward, CareDx Chief Scientific Officer.
In 2024, over 4,500 heart transplants were performed in the
About CareDx – The Transplant Company
CareDx, Inc., headquartered in
Forward Looking Statements
This press release includes forward-looking statements related to CareDx, Inc., including statements regarding the potential benefits and results that may be achieved with AlloSure Heart and AlloSure Kidney. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, all of which are difficult to predict and many of which are beyond CareDx’s control, that could cause actual results to differ materially from those projected, including risks that CareDx does not realize the expected benefits of AlloSure Heart and AlloSure Kidney. These statements are also subject to general economic and market factors, and global economic and marketplace uncertainties, among other risks discussed in CareDx’s filings with the Securities and Exchange Commission (the “SEC”), including, but not limited to, the Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed by CareDx with the SEC on February 28, 2025, and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
References:
- Feingold B, Rose-Felker K, West SC, et al. Early findings after integration of donor-derived cell-free DNA into clinical care following pediatric heart transplantation. Pediatr Transplant. 2022 Feb;26(1):e14124. doi: 10.1111/petr.14124.
- O'Halloran CP, Tannous P, Arva NC, et al. Histopathology, mRNA expression profile, and donor-derived cell-free DNA for assessment of rejection in pediatric heart transplantation. Pediatr Transplant. 2024 May;28(3):e14705. doi: 10.1111/petr.14705.
- Akabas L, Bravo SA, Zhang Y, et al. Progress in Noninvasive Surveillance for Acute Rejection in Pediatric Heart Transplant Recipients: A Real-World Analysis of Donor-Derived Cell-Free DNA-Based Surveillance Protocol. Clin Transplant. 2024 Oct;38(10):e15481. doi: 10.1111/ctr.15481.
- Feingold B, Rose-Felker K, West SC, et al. Short-term clinical outcomes and predicted cost savings of dd-cfDNA-led surveillance after pediatric heart transplantation. Clin Transplant. 2023 May;37(5):e14933. doi: 10.1111/ctr.14933.
- Boggi U, Vistoli F, Andres A, Arbogast, et al. First World Consensus Conference on pancreas transplantation: Part II - recommendations. Am J Transplant. 2021 Sep;21 Suppl 3(Suppl 3):17-59. doi: 10.1111/ajt.16750.
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Yoo A, Riedel A, Qian I, et al. An Initial Analysis of the Baseline Levels of Dd-cfDNA After Pancreas Transplantation: A Prospective Study From High-volume Centers in
the United States . Transplant Direct. 2023 Mar 15;9(4):e1459. doi: 10.1097/TXD.0000000000001459. - Williams MD, Fei M, Schadde E, et al. Early Experience Using Donor-derived Cell-free DNA for Surveillance of Rejection Following Simultaneous Pancreas and Kidney Transplantation. Transplant Direct. 2022 Apr 7;8(5):e1321. doi: 10.1097/TXD.0000000000001321.
- OPTN HRSA national database https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/, Accessed online March 6, 2025.
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Source: CareDx, Inc.
FAQ
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