CareDx, Inc. (Nasdaq: CDNA), a precision medicine company focused on transplant care, presented extensive clinical evidence supporting its transplant monitoring solutions at the International Society for Heart and Lung Transplantation (ISHLT) 45th Annual Meeting held April 27-30 in Boston, Massachusetts.
The company, along with collaborators from leading transplant centers, showcased data from 60 abstracts, including 19 oral presentations and two symposia, highlighting the clinical utility of their heart and lung transplant monitoring solutions.
HeartCare Shows Promise for Long-Term Graft Monitoring
New findings from the SHORE (Surveillance HeartCare Outcomes Registry) study demonstrated that HeartCare, which combines AlloSure Heart donor-derived cell-free DNA (dd-cfDNA) and AlloMap Heart gene expression profiling (GEP), provides significant clinical value in heart transplant management.
Key findings revealed that dual-positive HeartCare results were prognostic of worse outcomes even when biopsy results were normal. This suggests the molecular test may detect subclinical rejection or injury that traditional biopsies might miss.
"The latest evidence from our multi-center SHORE study suggests HeartCare is prognostic of long-term graft outcomes independent of biopsy results, and that HeartCare is utilized in a real-world setting to manage immunosuppression dosing," said John W. Hanna, CareDx President and CEO.
Real-world data presented at the meeting showed that clinicians are using HeartCare results not only to determine which patients require a biopsy but also to identify candidates for prednisone dose reduction, potentially minimizing immunosuppression-related complications.
The SHORE study, one of the largest heart transplant studies of its kind, includes over 2,700 heart transplant patients from 67 centers across the United States. A recent landmark study published in the Journal of Heart and Lung Transplantation showed that HeartCare outperforms dd-cfDNA alone in identifying rejection, with patients experiencing excellent outcomes despite undergoing fewer biopsies.
AlloSure Lung Shows Promise for CLAD Prediction
For lung transplant patients, new data from the ALAMO (AlloSure Lung Assessment and Metagenomics Outcomes) study indicated that AlloSure Lung may help predict the development of Chronic Lung Allograft Dysfunction (CLAD), a leading cause of death after lung transplantation.
The interim analysis presented during a CareDx-sponsored symposium showed that elevated levels of AlloSure dd-cfDNA early post-transplant were associated with future occurrence of restrictive allograft syndrome (RAS), a severe form of CLAD.
"The early findings from the ALAMO study are promising as it indicates that increased levels of AlloSure Lung dd-cfDNA may identify patients at higher risk of developing CLAD," said Dr. Ciara Shaver, Principal Investigator for ALAMO at Vanderbilt University Medical Center. "Furthermore, the ALAMO data show that AlloSure Lung may identify subclinical lung injury during CMV viremia. In these ways, AlloSure Lung may help clinicians to identify the patients with the greatest chance to respond to therapy to enhance long-term outcomes."
Additional findings showed that surveillance monitoring with AlloSure Lung effectively identified rising dd-cfDNA levels signaling the onset of acute cellular rejection and documented declining levels after treatment, suggesting its utility in monitoring treatment response.
Expanding Evidence Across Diverse Patient Populations
The breadth of data presented at ISHLT also highlighted the effectiveness of CareDx's monitoring solutions across diverse patient populations. Studies showed that HeartCare effectively monitored rejection in clinically relevant populations including women, Black Americans, and patients with chronic kidney disease.
In one study, early surveillance with HeartCare led to similar 5-year survival and rejection-free survival compared to using AlloMap and biopsy but required significantly fewer biopsies, potentially reducing procedural risks and patient discomfort.
Remote Monitoring Enhances Transplant Care
CareDx's AlloHome remote patient monitoring system was also featured in the presentations. Data showed that AlloHome enables real-time treatment adjustments and improved triage for lung transplant patients, potentially easing the workload on transplant center staff.
The system allows for continuous monitoring of vital parameters, helping to detect early signs of complications and facilitating timely interventions.
Expert Perspectives at CareDx Symposia
Two CareDx-sponsored symposia brought together experts from leading transplant centers to discuss the latest evidence in molecular management of heart and lung transplant patients.
The heart transplant symposium, "HeartCare in 2025: Is Molecular Multimodality the Secret to Liquid Biopsy?" featured panelists from NY Presbyterian/Columbia, Penn Medicine, UC San Diego Health, and Tampa General Hospital.
The lung transplant symposium, "From Bench to Bedside: Is Lung Transplant Ready for the dd-cfDNA Revolution?" included experts from Vanderbilt University, UCLA, and Miami Transplant Institute-Jackson Memorial Hospital.
"We are very pleased with the new data presented at ISHLT indicating that surveillance monitoring using AlloSure effectively detected rejection and could be used to monitor patient treatment responses," said Robert Woodward, CareDx Chief Scientific Officer.
The growing body of evidence presented at ISHLT 2025 underscores the expanding role of molecular diagnostic tools in transplant care, potentially improving long-term outcomes while reducing the need for invasive procedures.
