NGS Blood Test Detects AML and MDS Relapse Earlier Posttransplant

A non-invasive monitoring test using artificial intelligence and next-generation sequencing was able to identify cancer relapse significantly earlier than conventional methods in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) post-allogeneic hematopoietic cell transplant, according to clinical validation data presented at the 2026 Tandem Meetings.¹

The ACROBAT study (NCT04635384), a prospective multicenter observational trial conducted across 11 US transplant centers, included 198 evaluable subjects and 40 relapse events over 24 months. The test, called AlloHeme, demonstrated 85% sensitivity and 92% specificity for detecting relapse, with a 95% negative predictive value and 79% positive predictive value.¹

The area under the curve was 0.89. Most notably, the assay identified relapse a median of 41 days before clinical detection. At 6 months posttransplant, patients with positive results showed a 12-fold higher relapse risk compared with patients with negative results, a finding that was statistically significant at P <.001.

“These data represent an important step forward in relapse surveillance for AML and MDS,” Ran Reshef, MD, MSc, professor of medicine, Columbia University, and director, Translational Research for the Blood and Marrow Transplantation Program, said in a release.² “AlloHeme offers a simple, effective strategy to identify high-risk patients early, potentially opening the door for preemptive interventions to prevent relapse and improve survival.”

According to the test manufacturer, AlloHeme showed greater sensitivity and earlier detection capability than traditional standard of care methods including invasive bone marrow biopsy and multi-parameter flow cytometry for measurable residual disease, as reported by sites in the clinical trial.²

The approach is designed to be universally applicable, unlike marker-specific methods that require identifiable genetic targets. By using a tumor-naive strategy, AlloHeme enables surveillance for patients who lack conventional molecular markers, addressing a significant gap in posttransplant monitoring for AML and MDS.

“Cancer relapse remains a leading cause of mortality in patients with AML and MDS post allogeneic hematopoietic cell transplantation,” Jeff Teuteberg, MD, chief medical officer, CareDx, said in a release. The ACROBAT data highlight the potential clinical value this test offers physicians, patients, and cell therapy centers.”

CareDx plans to achieve CLIA laboratory readiness for AlloHeme in 2026, with commercial introduction in the United States expected in 2027. Payer coverage is anticipated in 2028.

REFERENCES

1. Reshef R, Ciurea S, Sobecks RM, et al. peripheral blood-based alloheme test enables robust relapse surveillance in post-HCT AML and MDS patients. Transplantation and Cellular Therapy. 2026;62;32(2):S53-S53. doi: 10.1016/j.jtct.2025.12.082

2. CareDx announces clinical validation results for alloheme™, the first ai‑powered ngs surveillance solution for AML and MDS post‑cell therapy. News release. February 12, 2026. Accessed February 12, 2026. https://investors.caredx.com/news/news-details/2026/CareDx-Announces-Clinical-Validation-Results-for-AlloHeme-the-First-AIPowered-NGS-Surveillance-Solution-for-AML-and-MDS-PostCell-Therapy/default.aspx