CareDx disclosed validation data from the ACROBAT study showing its AlloHeme cell‑free DNA assay for allogeneic hematopoietic cell transplant surveillance achieved 85% sensitivity and 92% specificity in detecting mixed chimerism associated with relapse. The assay demonstrated a median lead time of 41 days ahead of clinical relapse compared with standard monitoring. CareDx said it will publish the ACROBAT data as part of preparations for a commercial rollout next year and will focus on building clinical and payer adoption infrastructure. Investigators noted cases of false negatives correlated with missed testing windows and highlighted the assay’s strong negative predictive value in confirming deep remission. If commercialized as described, AlloHeme could displace or complement invasive bone‑marrow surveillance approaches and enable earlier intervention for relapse in acute leukemia and MDS, altering post‑transplant monitoring standards.
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