Hematogenix Assay Fuels FDA Approval for First CELMoD Therapy

In the Phase 3 EXCALIBER-RRMM trial, the Hematogenix Next Generation Flow Cytometry (NGF) assay provided the analytical foundation for evaluating patient responses. The data revealed that patients treated with ZENBEXUS in combination with daratumumab, hyaluronidase-fihj, and dexamethasone achieved an MRD-negative complete response rate of 41%. This outperformed the 21% rate observed in the control group—a statistically significant improvement that persuaded regulators to greenlight the new treatment.

Dr. Hytham Al-Masri, President and CEO of Hematogenix, noted that the inclusion of the laboratory’s specific methodology in the FDA’s official prescribing information validates the rigor required for registrational oncology trials. As the medical community increasingly adopts MRD negativity as a primary indicator of treatment success, the demand for standardized, high-sensitivity diagnostic platforms has grown. Hematogenix’s platform, designed to detect a single residual tumor cell among 100,000 healthy cells, is currently deployed across the company’s CAP-accredited and CLIA-certified facilities in the United States, the United Kingdom, Malaysia, and China.