AI-Powered Blood Test Flags Relapse Risk Earlier After Transplant

Clinicians need a universal, ultra-sensitive blood-based method capable of detecting emerging disease earlier than bone marrow or marker-specific approaches. A newly validated test now demonstrates earlier relapse detection using tumor-naive next-generation sequencing surveillance in these patients.

CareDx (Brisbane, CA, USA) has reported pivotal clinical validation results for AlloHeme, described as the first AI–powered, next‑generation sequencing (NGS) surveillance solution for AML and MDS after cell therapy. AlloHeme is a non‑invasive, blood‑based monitoring test designed to predict relapse following allogeneic hematopoietic cell transplant. The approach detects emerging relapse signals earlier than bone marrow–based or marker‑specific methods and is part of the company’s Transplant+ precision medicine portfolio.

Clinical validation data came from the prospective, multicenter ACROBAT study (NCT04635384) conducted across 11 U.S. transplant centers. In a 24‑month analysis of 198 evaluable subjects with 40 relapse events, AlloHeme demonstrated 85% sensitivity and 92% specificity, with a 95% negative predictive value and 79% positive predictive value; the area under the curve was 0.89. The assay identified relapse a median of 41 days before clinical detection and showed greater sensitivity and lead time than standard‑of‑care testing, including bone marrow and multiparameter flow cytometry for measurable residual disease, as reported by sites in the trial.

At six months post‑transplant, patients with positive AlloHeme results had a 12‑fold higher relapse risk compared with those testing negative (p<0.001). The data were presented at the 2026 Tandem Meetings. CareDx anticipates a sequenced U.S. rollout beginning with CLIA readiness in 2026, followed by commercial introduction in 2027 and anticipated payer coverage in 2028.

“Cancer relapse remains a leading cause of mortality in patients with AML and MDS post allogeneic hematopoietic cell transplantation,” said Dr. Jeff Teuteberg, MD, CareDx Chief Medical Officer. “AlloHeme represents the next wave of innovation within CareDx’s Transplant+ strategy as we expand from solid organ transplantation into cell therapy, by providing clinicians with a highly sensitive, blood‑based tool that can help identify relapse earlier. The ACROBAT data highlight the potential clinical value this test offers physicians, patients, and cell therapy centers. We are excited to bring this innovative technology to market in a capacity that only CareDx offers – alongside a full suite of patient and digital solutions for the cell therapy community.”

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