CareDx Announces Presentation of Data at 2025 Tandem Meetings Demonstrating Strong Performance of AlloHeme in Early Relapse Detection for Hematologic Malignancies
CareDx (CDNA) presented new data from the ACROBAT study for its AlloHeme™ test at the 2025 Tandem Meetings. The interim analysis, involving 229 patients from 11 U.S. transplant centers, demonstrated AlloHeme's effectiveness in monitoring relapse after allogeneic stem cell transplantation in patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS).
The study showed impressive performance metrics, including a hazard ratio of 40.5 (p<0.001) for relapse detection and a median lead time to relapse of 36 days. AlloHeme, an NGS-based test, proved more sensitive than current standard care methods for monitoring engraftment and relapse post-allogeneic hemopoietic stem cell transplantation.
CareDx (CDNA) ha presentato nuovi dati dallo studio ACROBAT per il suo test AlloHeme™ durante i Tandem Meetings del 2025. L'analisi intermedia, che ha coinvolto 229 pazienti provenienti da 11 centri di trapianto negli Stati Uniti, ha dimostrato l'efficacia di AlloHeme nel monitorare le recidive dopo il trapianto di cellule staminali allogeniche in pazienti con Leucemia Mieloide Acuta (AML) e Sindromi Mielodisplastiche (MDS).
Lo studio ha mostrato metriche di performance impressionanti, tra cui un rapporto di rischio di 40.5 (p<0.001) per la rilevazione delle recidive e un tempo medio di anticipo sulla recidiva di 36 giorni. AlloHeme, un test basato su NGS, si è dimostrato più sensibile rispetto ai metodi standard attuali per il monitoraggio dell'innesto e delle recidive dopo il trapianto allogenico di cellule staminali ematopoietiche.
CareDx (CDNA) presentó nuevos datos del estudio ACROBAT para su prueba AlloHeme™ en las Reuniones Tandem de 2025. El análisis intermedio, que involucró a 229 pacientes de 11 centros de trasplante en EE. UU., demostró la efectividad de AlloHeme en el monitoreo de recaídas después del trasplante de células madre alogénicas en pacientes con Leucemia Mieloide Aguda (LMA) y Síndromes Mielodisplásicos (SMD).
El estudio mostró métricas de rendimiento impresionantes, incluyendo un razón de riesgos de 40.5 (p<0.001) para la detección de recaídas y un tiempo medio de anticipación a la recaída de 36 días. AlloHeme, una prueba basada en NGS, demostró ser más sensible que los métodos estándar actuales para monitorear la injerto y las recaídas después del trasplante de células madre hematopoyéticas alogénicas.
CareDx (CDNA)는 2025년 탠덤 미팅에서 AlloHeme™ 테스트에 대한 ACROBAT 연구의 새로운 데이터를 발표했습니다. 11개의 미국 이식 센터에서 229명의 환자를 포함한 중간 분석 결과, AlloHeme이 급성 골수성 백혈병(AML) 및 골수형성이상증후군(MDS) 환자에서 동종 줄기세포 이식 후 재발 모니터링에 효과적임을 보여주었습니다.
이 연구는 재발 탐지에 대한 위험 비율 40.5 (p<0.001) 및 재발까지의 평균 선행 시간 36일 등 인상적인 성과 지표를 보여주었습니다. NGS 기반의 AlloHeme은 동종 조혈모세포 이식 후 이식 및 재발 모니터링을 위한 현재의 표준 치료 방법보다 더 민감한 것으로 입증되었습니다.
CareDx (CDNA) a présenté de nouvelles données de l'étude ACROBAT pour son test AlloHeme™ lors des réunions Tandem de 2025. L'analyse intermédiaire, impliquant 229 patients provenant de 11 centres de transplantation aux États-Unis, a démontré l'efficacité d'AlloHeme dans le suivi des rechutes après une transplantation de cellules souches hématopoïétiques allogéniques chez des patients atteints de leucémie myéloïde aiguë (LMA) et de syndromes myélodysplasiques (SMD).
L'étude a montré des indicateurs de performance impressionnants, y compris un rapport de risques de 40,5 (p<0.001) pour la détection des rechutes et un délai moyen avant la rechute de 36 jours. AlloHeme, un test basé sur NGS, s'est avéré plus sensible que les méthodes de soin standard actuelles pour surveiller l'engraftment et les rechutes après la transplantation de cellules souches hématopoïétiques allogéniques.
CareDx (CDNA) präsentierte neue Daten aus der ACROBAT-Studie für seinen AlloHeme™ Test auf den Tandem Meetings 2025. Die Zwischenanalyse, die 229 Patienten aus 11 US-Transplantationszentren einbezog, zeigte die Wirksamkeit von AlloHeme bei der Überwachung von Rückfällen nach allogenem Stammzelltransplantation bei Patienten mit akuter myeloischer Leukämie (AML) und myelodysplastischen Syndromen (MDS).
Die Studie zeigte beeindruckende Leistungskennzahlen, darunter ein Hazard Ratio von 40,5 (p<0.001) zur Rückfalldetektion und eine mittlere Vorlaufzeit bis zum Rückfall von 36 Tagen. AlloHeme, ein NGS-basierter Test, erwies sich als empfindlicher als die derzeitigen Standardmethoden zur Überwachung der Engraftment und Rückfälle nach allogenem hämatopoetischem Stammzelltransplantation.
- Strong clinical performance with hazard ratio of 40.5 (p<0.001) for relapse detection
- 36-day median lead time advantage in detecting relapse compared to conventional methods
- Successfully completed interim analysis of large-scale study across 11 transplant centers
- None.
Insights
The ACROBAT study interim results reveal a groundbreaking advancement in post-transplant monitoring technology. The reported hazard ratio of 40.5 (p<0.001) is remarkably high, indicating AlloHeme is a powerful predictor of relapse risk. To put this in perspective, most diagnostic tests in oncology typically show hazard ratios between 2 and 10, making this result particularly impressive.
The 36-day median lead time for relapse detection is clinically significant. This window allows physicians to initiate intervention strategies such as immunosuppression adjustment or donor lymphocyte infusion before overt relapse occurs, potentially improving survival outcomes. The study's scope, involving 229 patients across multiple centers, provides robust validation of the technology's reliability.
AlloHeme's NGS-based platform offers superior sensitivity in detecting minimal residual disease compared to traditional chimerism analysis methods. This technological advantage addresses a critical unmet need in post-transplant care, where early intervention is important for improving outcomes. The test's ability to detect small changes in mixed chimerism represents a significant advancement over current standard-of-care methods.
From a market perspective, this development positions CareDx to expand its footprint in the hematology-oncology space, complementing its existing transplant diagnostics portfolio. The potential market is substantial, considering there are approximately 24,000 allogeneic stem cell transplants performed annually in the U.S., with AML and MDS being primary indications.
New Data from the ACROBAT Study Shows AlloHeme Detects Cancer Relapse with Clinically Meaningful Lead Time
In an oral presentation, a one-year interim analysis of the ACROBAT prospective, multi-center study showed that AlloHeme™ is an accurate and sensitive test for monitoring relapse after allogeneic stem cell transplantation in Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS). By measuring small changes in mixed chimerism, AlloHeme demonstrated excellent performance characteristics with a hazard ratio (HR) of 40.5 (p<0.001) for relapse, and a clinically meaningful median lead time to relapse of 36 days. The analysis included one-year interim follow-up data from a cohort of 229 patients with AML and MDS from 11 stem cell transplant centers across the
“We are extremely pleased with the results of the ACROBAT study which demonstrates that AlloHeme is highly accurate in predicting risk of relapse in patients who have undergone a hematopoietic cell transplant,” said Dr. Monzr M. Al Malki, Associate Professor, and Director of Unrelated Donor Bone Marrow Transplant Program at City of Hope National Medical Center. “This study gets us one step closer to having a highly reliable molecular biomarker that enables us to assess the status of the stem cell engraftment and predict risk of relapse.”
CareDx's AlloHeme is an NGS-based test that has been shown to be more sensitive than the current standard of care methods for monitoring engraftment and relapse post-allogeneic hemopoietic stem cell transplantation for hematologic malignancies.
“The interim results of the ACROBAT study build upon our growth strategy to expand into hematology oncology. With AlloHeme, we can detect relapse after allogeneic stem cell transplantation prior to conventional methods, giving clinicians the significant lead time they need to intervene sooner,” said Marica Grskovic, PhD, CareDx Chief Strategy Officer. “We are very pleased with these results demonstrating the high sensitivity of the AlloHeme assay and its selection for an oral presentation at the Tandem Meetings given the significant impact it may have on patient outcomes through earlier detection of malignancy recurrence.”
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 AlloHeme. 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 AlloHeme. These statements are also subject to general economic and market factors, and 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, 2023 filed by CareDx with the SEC on February 28, 2024, the Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 filed by CareDx with the SEC on May 9, 2024, the Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2024 filed by CareDx with the SEC on July 31, 2024, the Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 filed by CareDx with the SEC on November 4, 2024, 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250213449450/en/
Media Contacts
Anna Czene
818-731-2203
aczene@caredx.com
Investor Relations
Caroline Corner
investor@caredx.com
Source: CareDx, Inc.
FAQ
What are the key findings of CareDx's ACROBAT study for AlloHeme (CDNA)?
How many patients and centers were involved in CareDx's AlloHeme ACROBAT study?
What advantages does AlloHeme offer over current standard of care methods for CDNA?
What types of cancer does CareDx's AlloHeme test monitor (CDNA)?
