MedPath

CareDx's AlloSeq cfDNA Test Shows Strong Performance in Large European Kidney Transplant Study

• A multicenter study of 580 kidney transplant patients demonstrates AlloSeq cfDNA's high accuracy in detecting allograft rejection, achieving an AUC of 0.758.

• The study validates AlloSeq cfDNA's performance consistency with CareDx's established AlloSure Kidney test across various clinical scenarios and timepoints.

• Results published in Transplant International confirm the test's reliability in monitoring post-transplant outcomes, supporting its clinical utility in transplant care.

A large-scale European study has validated the effectiveness of CareDx's AlloSeq cfDNA test in detecting kidney transplant rejection, marking a significant advancement in transplant monitoring technology. The findings, published in Transplant International, demonstrate the test's robust performance in identifying allograft rejection among kidney transplant recipients.
The multicenter prospective study, conducted across three major European transplant centers, enrolled 580 kidney transplant patients. Researchers found that AlloSeq cfDNA exhibited high accuracy in detecting allograft rejection, with data showing a significant differentiation between rejection and non-rejection cases. The test achieved an Area Under the Curve (AUC) of 0.758, indicating strong diagnostic capability.

Clinical Performance and Validation

The study's results confirmed the consistency between AlloSeq cfDNA and CareDx's laboratory-developed AlloSure Kidney test. This equivalence was demonstrated across multiple clinical scenarios, including:
  • Various post-transplant timepoints
  • States of allograft stability
  • Different allograft rejection subcategories
Each scenario was validated against biopsy-proven rejection cases, providing robust evidence for the test's reliability.

Implications for Transplant Care

The validation of AlloSeq cfDNA represents a significant step forward in transplant monitoring. Cell-free DNA testing offers a less invasive alternative to traditional biopsy methods, potentially allowing for more frequent and convenient monitoring of transplant recipients. This technology could enable earlier detection of rejection episodes, potentially leading to more timely interventions and improved patient outcomes.

Technical Innovation

The study's findings underscore the advancement in molecular diagnostic capabilities for transplant care. By demonstrating comparable performance to the established AlloSure test, AlloSeq cfDNA provides clinicians with an additional validated tool for monitoring transplant patients. This expanded testing option could enhance the accessibility of advanced transplant monitoring across different healthcare settings.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

CareDx's AlloHeme Test Shows 93% Sensitivity in Early Detection of AML and MDS Relapse Post-Transplant

Interim results from the ACROBAT study demonstrate AlloHeme's superior accuracy in detecting post-transplant relapse in AML and MDS patients, with 93% sensitivity and 88% specificity.
The NGS-based assay provides a median 36-day early warning before clinical relapse, potentially offering a crucial window for therapeutic intervention.

ctDNA Status Predicts Celecoxib Benefit in Stage III Colon Cancer

A subgroup analysis of the CALGB/SWOG 80702 trial reveals that positive circulating tumor DNA (ctDNA) status is associated with poorer disease-free survival (DFS) in stage III colon cancer.
Celecoxib significantly improved DFS outcomes in ctDNA-positive patients compared to placebo, suggesting a potential targeted treatment approach.

Exact Sciences' Oncodetect Shows Promising Results in MRD Detection

Exact Sciences' Oncodetect test demonstrated 78% sensitivity in post-surgical checks and 91% sensitivity during surveillance monitoring for molecular residual disease (MRD).
The diagnostic test achieved 80% and 94% specificity in post-surgical checks and surveillance monitoring, respectively, indicating reliable performance.

Ultrasensitive ctDNA Test Predicts Relapse Risk and Survival in Early-Stage Lung Cancer

A new ultrasensitive ctDNA test, NeXT Personal, shows promise in predicting lung cancer relapse risk and overall survival in early-stage patients.
The test, which detects circulating tumor DNA in blood, identified patients with low ctDNA levels who were less likely to relapse after surgery.

DiaCarta's Blood Test Reduces Colonoscopy Needs in CRC Screening

DiaCarta's QuantiDNA™ blood test reduces the need for colonoscopies by 33% in FIT-positive colorectal cancer (CRC) screening patients.
The clinical trial, involving 711 participants, demonstrated the test's non-inferiority to standard of care in detecting significant colorectal lesions.

CareDx and TC BioPharm Partner to Enhance AlloCell Monitoring in AML Trial

CareDx partners with TC BioPharm to perform pharmacokinetic analysis in the ACHIEVE clinical trial using its AlloCell solution.
The ACHIEVE trial is a Phase II study evaluating TCB008, an allogeneic gamma-delta T-cell therapy, for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS).

clonoSEQ Data Show MRD Assessment Impacts Blood Cancer Treatment Decisions

Data from the ECOG-ACRIN EA4151 trial suggests auto-HCT may not benefit MCL patients in first complete remission with undetectable MRD.
FELIX study data indicates deep molecular remission correlates with improved outcomes in relapsed/refractory B-ALL patients treated with obecabtagene autoleucel.

ANGLE and Illumina's Dual DNA Analysis Improves Lung Cancer Biomarker Detection

ANGLE plc and Illumina have successfully combined technologies for dual analysis of circulating tumor DNA (ctDNA) and circulating tumor cell DNA (CTC-DNA).
In a study of 27 lung cancer patients, combined analysis identified twice as many mutations compared to ctDNA analysis alone, enhancing biomarker detection.

Devyser and Thermo Fisher Collaborate to Secure FDA Approval for Kidney Transplant Monitoring Test

Devyser and Thermo Fisher Scientific are partnering to gain FDA approval for One Lambda Devyser Accept cfDNA, an NGS test for kidney transplant monitoring.
The test detects donor-derived cell-free DNA (ddcfDNA) in kidney transplant patients' blood samples, aiding in post-transplant monitoring.

Imlifidase Demonstrates Superior Efficacy Over Plasmapheresis in Kidney Transplant Recipients with Antibody-Mediated Rejection

A Phase 2 trial reveals imlifidase significantly reduces donor-specific antibodies (DSAs) in kidney transplant recipients experiencing antibody-mediated rejection, surpassing the effectiveness of plasmapheresis (PLEX).
Imlifidase achieved a median DSA reduction of 97% by day 5, compared to 42% with PLEX, showcasing a more rapid and efficient antibody depletion.

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy