CareDx reported that the ACROBAT study, a prospective, multi‑center trial of 198 evaluable patients, achieved 85% sensitivity, 92% specificity, 95% negative predictive value, 79% positive predictive value, and an area under the curve of 0.89 for detecting relapse in acute myeloid leukemia and myelodysplastic syndrome patients after allogeneic hematopoietic cell transplantation.
The test identified relapse a median of 41 days before clinical detection, and patients with a positive AlloHeme™ result faced a 12‑fold higher relapse risk at six months, underscoring the clinical value of earlier, blood‑based surveillance.
AlloHeme™ is positioned as CareDx’s first‑in‑class, AI‑powered next‑generation sequencing surveillance solution and represents a strategic expansion of the company’s Transplant+ strategy into the AML/MDS post‑cell‑therapy market, a rapidly growing segment that has historically lacked sensitive, non‑invasive monitoring tools.
The ACROBAT study’s 24‑month analysis supersedes earlier interim results presented at the 2025 Tandem Meetings, which reported different performance metrics; the current data confirm the test’s robustness across a larger cohort and longer follow‑up.
CareDx plans to achieve CLIA readiness in 2026, launch the test commercially in the United States in 2027, and expects payer coverage to begin in 2028, positioning the product for early market entry and reimbursement.
"Cancer relapse remains a leading cause of mortality in patients with AML and MDS post allogeneic hematopoietic cell transplantation. 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," said Dr. Jeff Teuteberg, Chief Medical Officer. "These data represent an important step forward in relapse surveillance for AML and MDS. 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," added Dr. Ran Reshef, Professor of Medicine at Columbia University.
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