Landmark Independent Publication in Nature Medicine Validates CareDx AlloView AI-Enabled Risk Prediction Model and Demonstrates AlloSure Kidney Detects Subclinical Rejection in Stable Patients
Surveillance Monitoring with Both AlloSure Kidney and the AlloView AI-Enabled Risk Prediction Model Improves the Detection of All Types of Allograft Rejection
AlloSure Kidney Detected Subclinical Rejection in Clinically Stable Patients and AlloSure Kidney dd-cfDNA Levels were Elevated Prior to Biopsy Proven Rejection in an Analysis of Patients Receiving Consecutive Biopsies
AlloSure dd-cfDNA Levels Declined in Response to Immunosuppression Treatment Suggesting There May be Utility in Therapy Monitoring for Recovery or Progression
“This landmark study in Nature Medicine further establishes the clinical utility of AlloSure Kidney and the added value of AlloView, our AI-enabled risk prediction model, in detecting the presence, activity and severity of allograft rejection. These findings contribute to a growing body of evidence establishing new standards globally in the routine monitoring of rejection and treatment response in kidney transplant patients," said
The international multicenter study of 2,882 patients with AlloSure Kidney dd-cfDNA levels and matched biopsy results was conducted by the
The study results published in Nature Medicine demonstrated the following1:
- Surveillance monitoring with AlloSure Kidney and AlloView improves the detection of antibody-mediated rejection (ABMR), T-cell mediated rejection (TCMR), and subclinical rejection when compared to standard of care measures.
- AlloSure Kidney detected subclinical rejection in clinically stable patients.
- AlloSure Kidney dd-cfDNA levels were elevated prior to biopsy proven rejection in an analysis of patients receiving consecutive biopsies.
- AlloSure Kidney dd-cfDNA levels were associated with stability in patients with immune quiescence, a significant increase for patients with de novo allograft rejection, a significant decrease for patients with successfully treated rejection, and remained at elevated levels for patients with persistent allograft rejection.
- In patients with acute rejection, AlloSure Kidney dd-cfDNA levels were associated with the severity of acute rejection.
“This study underscores AlloSure dd-cfDNA’s role as a real-time indicator of kidney transplant rejection, enabling clinicians to intervene earlier before rejection occurs and to monitor post-treatment progress without resorting to unnecessary biopsy procedures,” said
CareDx’s AlloSure dd-cfDNA was made commercially available in 2017, the industry’s first dd-cfDNA for use to non-invasively identify the risk of allograft injury and rejection in kidney transplantation. Since then, AlloSure has also become available for clinical use in heart and lung transplant recipients. AlloView, an AI-enabled risk prediction model is now commercially available. AlloView optimizes patient risk prediction by integrating artificial intelligence, AlloSure and standard of care measures.2
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References
- Aubert, O., Ursule-Dufait, C., Brousse, R., et al. Cell-Free DNA for the detection of kidney allograft rejection. Nat Med (2024). https://doi.org/10.1038/s41591-024-03087-3
- AlloView is intended to support the healthcare provider’s independent assessment of the patient’s post-transplant status. AlloView is not intended to diagnose a condition or determine a patient’s course of treatment. An AlloSure dd-cfDNA test result is a required input of AlloView.
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