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

Access the publication

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

Access the publication

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

Access the publication

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

Access the publication

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

Kidney
2020
Sureshlkumar, Chopra
Impact of Kidney transplant type and previous transplant on baseline donor-derived cell-free DNA
Transplant International
Access the publication
Heart
2019
Khush, Kobashigawa
Noninvasive detection of graft injury after heart transplant using donor‐derived cell‐free DNA: A prospective multicenter study
American Journal of Transplantation
Access the publication
Kidney
2018
Jordan, Matas
Donor-derived Cell-free DNA Identifies Antibody-mediated Rejection in Donor Specific Antibody Positive Kidney Transplant Recipients
Transplantation Direct
Access the publication
Kidney
2017
Bloom, Brennan
Cell-Free DNA and Active Rejection in Kidney Allografts
American Journal of Transplantation
Access the publication
Kidney
2017
Bromberg, Bloom
Biological Variation of Donor-Derived Cell-Free DNA in Renal Transplant Recipients: Clinical Implications
Journal of Applied Laboratory Medicine
Access the publication
Heart
2016
Grskovic, Woodward
Validation of a Clinical-Grade Assay to Measure Donor-Derived Cell-Free DNA in Solid Organ Transplant Recipients
Journal of Molecular Diagnostics
Access the publication
Heart
2015
Crespo-Leiro, Vanhaecke
Performance of Gene-Expression Profiling Test Score Variability to Predict Future Clinical Events in Heart Transplant Recipients
BMC Cardiovascular Disorders
Access the publication
Heart
2015
Kobashigawa, Esmailian
Randomized Pilot Trial of Gene Expression Profiling Versus Heart Biopsy in the First Year After Heart Transplant Early Invasive Monitoring Attenuation Through Gene Expression Trial
Circulation: Heart Failure
Access the publication
Lung
2011
Aracasoy, Keshavjee
Pathologic Interpretation of Transbronchial Biopsy for Acute Rejection of Lung Allograft Is Highly Variable
American Journal of Transplantation
Access the publication
Heart
2010
Pham, Valantine
Gene-Expression Profiling for Rejection Surveillance after Cardiac Transplantation
New England Journal of Medicine
Access the publication
Heart
2006
Deng, Hunt
Noninvasive Discrimination of Rejection in Cardiac Allograft Recipients Using Gene Expression Profiling
American Journal of Transplantation
Access the publication

Publications

Landmark Studies

KOAR – Kidney Allograft Outcomes Registry

SHORE – Surveillance Heart Outcomes Registry

AlloSure® – Nature Medicine Publication