CareDx has announced strong AlloHeme clinical validation results, introducing the first AI-powered next-generation sequencing (NGS) surveillance test designed to predict relapse in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) after allogeneic hematopoietic cell transplant (HCT). The findings were presented at the 2026 Tandem Meetings and mark a major step forward in post-transplant cancer monitoring.
What AlloHeme Clinical Validation Means for Patients
AlloHeme provides a non-invasive, blood-based method to detect early relapse signals. Unlike traditional bone marrow tests, the solution offers a universal and ultra-sensitive approach. As a result, clinicians can identify risks sooner and potentially intervene earlier.
The test forms a key part of CareDx’s Transplant+ strategy. Moreover, it expands the company’s precision medicine portfolio beyond solid organ transplantation into cell therapy, hematology, and oncology.
Dr. Jeff Teuteberg, Chief Medical Officer at CareDx, noted that cancer relapse remains a leading cause of mortality in AML and MDS patients following transplantation. Therefore, tools that support earlier detection could significantly improve outcomes.
ACROBAT Study Demonstrates Strong Performance
Researchers conducted the prospective, multi-center ACROBAT study across 11 U.S. transplant centers. The 24-month analysis evaluated 198 patients and recorded 40 relapse events.
Key results include:
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85% sensitivity and 92% specificity
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95% negative predictive value and 79% positive predictive value
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Area under the curve of 0.89
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Median detection 41 days earlier than clinical diagnosis
Additionally, patients with positive AlloHeme results showed a 12-fold higher relapse risk within six months compared to those with negative results. The assay also outperformed standard monitoring methods such as bone marrow testing and multi-parameter flow cytometry.
Dr. Ran Reshef of Columbia University emphasized that early identification of high-risk patients could enable preemptive treatments and improve survival rates.
Strategic Expansion into Cell Therapy
The AlloHeme clinical validation supports CareDx’s broader entry into the cell therapy and hematologic malignancy market. Currently, AML and MDS lack a widely applicable molecular monitoring solution, creating a strong opportunity for innovation.
CareDx plans a phased U.S. rollout. The company expects CLIA readiness in 2026, followed by a commercial launch in 2027 and anticipated payer coverage in 2028. Consequently, healthcare providers may soon gain access to a more advanced surveillance tool.
Why This Matters for Oncology Innovation
The successful AlloHeme clinical validation highlights the growing role of AI-driven diagnostics in cancer care. Furthermore, earlier relapse detection can help physicians act faster, reduce complications, and improve long-term survival.
As precision medicine evolves, solutions like AlloHeme demonstrate how technology can transform transplant monitoring and reshape the future of oncology care.
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