Publications

Landmark Studies

Summary

KOAR is a large real-world registry of kidney transplant outcomes, tracking over 1,700 patients across 56 centers. This pivotal study demonstrated that AlloSure donor-derived cell-free DNA testing enables earlier detection of rejection and was shown to improve biopsy yield.

Citation

Bromberg, Kothari. dd-cfDNA Significantly Improves Rejection Yield in Kidney Transplant Biopsies. American Journal of Transplantation. 2025

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1,743 patients across 56 transplant centers
18,584 AlloSure® Kidney tests performed
Elevated AlloSure® detected rejection risk up to 4 months before biopsy
4x higher likelihood of detecting rejection on for-cause biopsies in patients with elevated AlloSure®
6x higher likelihood of detecting rejection on surveillance biopsies in patients with elevated AlloSure®

Summary

SHORE, a landmark, prospective, observational, multicenter registry in heart transplant. The pivotal study demonstrated the clinical utility and prognostic value of HeartCare.

Citation

Teuteberg, Uriel. Multimodal Molecular Testing Provides Prognostic Value for Heart Transplant Recipients . Journal of Heart and Lung Transplantation. 2025

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Khush, Teuteberg. Surveillance with dual noninvasive testing for acute cellular rejection after heart transplantation: Outcomes from the Surveillance HeartCare Outcomes Registry. Journal of Heart and Lung Transplantation. 2024

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2,732 transplant patients across 67 transplants centers in United States since 2018
97.3% of patients monitored with HeartCare had normal graft function at 2 yrs
Patients monitored with HeartCare had a 94.9% survival rate at 2 years
Patients with AlloMap(+) AlloSure(+) are 6x more likely to have biopsy confirmed ACR compared to -/- result.
Patients with AlloMap(+) AlloSure(+) were ~2X more likely to experience poor outcomes, even in absence of histological rejection.

Summary

This peer-reviewed study in Nature Medicine validated AlloSure® as a powerful, noninvasive tool for early detection of kidney transplant rejection. The findings influenced clinical protocols, payer policies, and widespread adoption of molecular diagnostics in kidney transplant monitoring.

Citation

Aubert, Loupy. Cell-free DNA for the detection of kidney allograft rejection. Nature Medicine. 2024

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Landmark evidence supporting AlloSure® clinical utility
Early detection of active rejection before clinical symptoms
Reinforced confidence in molecular surveillance
Positive coverage decisions from major payers

Organs

Year

Heart
2025
Bravo, Lytrivi
Transition to a non-invasive rejection surveillance protocol with donor-derived cell-free DNA in pediatric heart transplant recipients
Progress in Pediatric Cardiology
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Kidney
2025
Bromberg, Kothari
dd-cfDNA Significantly Improves Rejection Yield in Kidney Transplant Biopsies
American Journal of Transplantation
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Heart
2025
Kim, Hall
Donor-Derived Cell-Free DNA in Antibody-Mediated Rejection: An Analysis of the Surveillance HeartCare Outcomes Registry
JACC Heart Failure
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Heart
2025
Teuteberg, Uriel
Multimodal Molecular Testing Provides Prognostic Value for Heart Transplant Recipients
Journal of Heart and Lung Transplantation
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Kidney
2024
Aubert, Loupy
Cell-free DNA for the detection of kidney allograft rejection
Nature Medicine
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Heart
2024
Khush, Teuteberg
Surveillance with dual noninvasive testing for acute cellular rejection after heart transplantation: Outcomes from the Surveillance HeartCare Outcomes Registry
Journal of Heart and Lung Transplantation
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Heart
2024
Moayedi, Teuteberg
Rejection Surveillance After Heart Transplantation: Is Paired Noninvasive Testing the New Gold Standard?
Transplantation
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Heart
2023
Feingold, Zinn
Short-term clinical outcomes and predicted cost savings of dd-cfDNA-led surveillance after pediatric heart transplantation
Clinical Transplantation
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Heart
2022
Amadio, Moayedi
Sparing the Prod: Providing an Alternative to Endomyocardial Biopsies With Noninvasive Surveillance After Heart Transplantation During COVID-19
CJC Open
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Kidney
2022
Bu, Alhamad
Clinical outcomes from the Assessing Donor-derived cell-free DNA Monitoring Insights of Kidney Allografts with Longitudinal surveillance (ADMIRAL) study
Kidney International
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Kidney
2022
Cheung, Phan
Validation of a Gene Expression Signature to Measure Immune Quiescence in Kidney Transplant Patients in the CLIA setting
Biomarkers in Medicine
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Kidney
2022
Dandamudi, Dharnidharka
Longitudinal Evaluation of Donor-Derived Cellfree DNA in Pediatric Kidney Transplantation
Clinical Journal of the American Society of Nephrology
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Heart
2022
Henricksen, Teuteberg
Combining Donor Derived Cell Free DNA and Gene Expression Profiling for Non-Invasive Surveillance after Heart Transplantation
Clinical Transplantation
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Lung
2022
Keller, Agbor-Enoh
Donor-derived cell-free DNA as a composite marker of acute lung allograft dysfunction in clinical care
Journal of Heart and Lung Transplantation
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Kidney
2022
Obrisca, Leca
Combining donor‑derived cell‑free DNA and donor specific antibody testing as non‑invasive biomarkers for rejection in Kidney transplantation
Scientific Reports
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Kidney
2021
Akalin, Bromberg
Clinical Validation of an Immune Quiescence Gene Expression Signature in Kidney Transplantation
Kidney360
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Kidney
2021
Anand, Srinivas
Longitudinal Variance of Donor-Derived Cell-Free DNA (dd-cfDNA) in Stable Kidney Transplant (KTx) Patients are Influenced by Donor/Recipient Variables
Clinical Transplantation
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Heart
2021
Gondi, Borkon
Single-Center Utilization of Donor-Derived Cell-Free DNA Testing in the Management of Heart Transplant Patients
Clinical Transplantation
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Kidney
2021
Gupta, Halloran
Correlation of Donor-Derived Cell-free DNA with Histology and Molecular Diagnoses of Kidney Transplant Biopsies
Transplantation
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Lung
2021
Khush, Nicolls
Donor-derived, cell-free DNA levels by next-generation targeted sequencing are elevated in allograft rejection after lung transplantation
European Respiratory Journal Open Research
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Kidney
2021
Pai, Kumar
Clinical Rationale for Routine Testing Schedule Using Donor-Derived Cell-Free DNA After Kidney Transplantation
Annals of Transplantation
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Kidney
2020
Huang, Haas
Donor-derived Cell-free DNA Combined With Histology Improves Prediction of Estimated Glomerular Filtration Rate Over Time in Kidney Transplant Recipients Compared With Histology Alone
Transplantation Direct
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Kidney
2020
Puliyanda, Jordan
Donor‐derived cell‐free DNA (dd‐cfDNA) for detection of allograft rejection in pediatric Kidney transplants
Pediatric Transplantation
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Lung
2020
Sayah, Ross
Plasma Donor-derived Cell-free DNA Levels Are Increased During Acute Cellular Rejection After Lung Transplant: Pilot Data
Transplant Direct
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Kidney
2020
Stites, Gupta
High levels of dd-cfDNA identify patients with TCMR 1A and borderline allograft rejection at elevated risk of graft injury
American Journal of Transplantation
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Publications

Landmark Studies

KOAR – Kidney Allograft Outcomes Registry

SHORE – Surveillance Heart Outcomes Registry

AlloSure® – Nature Medicine Publication