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Landmark ADMIRAL Study Publication with CareDx’s AlloSure Kidney is the First Long-Term Multicenter Prospective Clinical Validation for Routine Organ Transplant Surveillance
ADMIRAL Study Shows AlloSure Detects Clinical and Subclinical ABMR and TCMR, and Predicts Long-Term Outcomes for Kidney Transplant Patients AlloSure Showed
About this update from Caredx, Inc.
[{"type":"text","content":"ADMIRAL Study Shows AlloSure Detects Clinical and Subclinical ABMR and TCMR, and Predicts Long-Term Outcomes for Kidney Transplant Patients AlloSure Showed 62% Improvement Over Standard of Care Serum Creatinine SOUTH SAN FRANCISCO, Calif., Jan. 12, 2022 (GLOBE NEWSWIRE) -- CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients – today announced the publication1 of results from a large, multicenter prospective study showing that AlloSure® Kidney is an early and accurate measure of allograft injury in routine organ transplant surveillance, and is able to predict long-term graft survival outcomes. The ADMIRAL study, Assessing AlloSure Dd-cfDNA Monitoring Insights of Renal Allografts With Longitudinal Surveillance (NCT04566055), monitored 1,092 kidney transplant patients, in a real-world setting, from seven transplant centers for up to three years using the AlloSure Kidney donor-derived cell-free DNA (dd-cfDNA) as part of the standard of care. The demographic characteristics of the study participants included a diverse population that is consistent with the U.S. adult population reported to the United Network of Organ Sharing (UNOS) registry, including 28% African American and 17% Hispanic patients. The study results published in Kidney International1 showed that AlloSure Kidney can be: Used in both subclinical and clinical rejection: Elevated AlloSure dd-cfDNA (>0.5%) strongly correlated with clinical and subclinical allograft rejection (p 0.5% associated with a 271% increased risk of dnDSA development (p=0.001).Leading indicator of donor-specific antibodies: AlloSure dd-cfDNA was elevated 91 days (median) ahead of DSA identification.Superior to serum creatinine: AlloSure showed a 62% relative improvement over serum creatinine in identifying subclinical and clinical rejection (area under the curve [AUC] of 80% vs. 49% respectively).Used to identify estimated glomerular filtration rate(eGFR) decline: Persistently elevated AlloSure (>1 result above 0.5%) predicted a > 25% decline in eGFR over 3 years (HR 1.97, p = 0.041), while persistently low levels identify allograft quiescence. “We are proud to continue to bring transplant innovation for patients, where AlloSure is now the first donor-d...