Clinical validation of AlloHeme announced: The first AI-powered NGS surveillance solution for AML and MDS post cell therapy
CareDx, Inc., The Transplant Company, announced pivotal clinical validation results of AlloHeme, a non-invasive, next generation sequencing (NGS)–based, and artificial intelligence (AI)-powered monitoring test designed to predict relapse in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) following allogeneic hematopoietic cell transplant (HCT).
This approach enables the detection of emerging relapse signals earlier than traditional bone marrow-based or marker-specific methods, offering a universal, ultrasensitive, blood-based surveillance solution for post HCT AML and MDS patients. The data was generated as part of the ACROBAT study.
The ACROBAT study is a prospective, multicenter, observational trial conducted across 11 U.S. transplant centers. The 24-month analysis included 198 evaluable subjects and 40 relapse events. AlloHeme demonstrated strong clinical performance, including 85% sensitivity and 92% specificity. This translated to a 95% negative predictive value, 79% positive predictive value, and an area under the curve of 0.89. The assay identified relapse a median of 41 days before clinical detection. At 6 months post-transplant, patients with positive AlloHeme results showed a 12-fold higher relapse risk compared to patients with negative AlloHeme results (p<0.001). AlloHeme also demonstrated greater sensitivity and lead time than traditional standard of care testing, including more invasive bone marrow and multiparameter flow cytometry (MFCMRD), as reported by sites in the clinical trial conducted across 11 U.S. transplant centers.
