Hematogenix’s MM MRD Assay Underpins FDA Accelerated Approval of Bristol Myers Squibb’s ZENBEXUS™, the First Approved CELMoD Therapy for Multiple Myeloma

Hematogenix's proprietary Multiple Myeloma MRD (MM MRD) assay measured the primary efficacy endpoint cited in the FDA-approval of ZENBEXUS (iberdomide), reinforcing Hematogenix's role as a specialized global leader in registrational oncology trials.

TINLEY PARK, Ill., Aug. 19, 2026 Hematogenix®, a global specialty laboratory and contract research organization focused on oncology and hematopathology, announced that its proprietary Next Generation Flow Cytometry  (NGF) assay for MM MRD served as the analytical method for the pivotal efficacy endpoint supporting the U.S. Food and Drug Administration’s (FDA) accelerated approval of Bristol Myers Squibb’s ZENBEXUS™ (iberdomide).  ZENBEXUS™  is the first CELMoD therapy approved by the FDA for multiple myeloma.

The FDA-approved prescribing information for ZENBEXUS states that minimal residual disease (MRD)-negative complete response, the trial’s major efficacy outcome measure, was assessed “based on a threshold of 10⁻⁵ using a  Hematogenix Next Generation Flow Cytometry assay.” In the Phase 3 EXCALIBER-RRMM trial, patients treated with ZENBEXUS in combination with daratumumab and hyaluronidase-fihj and dexamethasone (ZDd) achieved an MRD-negative complete response rate of 41%, compared with 21% for patients treated with daratumumab, bortezomib, and dexamethasone (DVd) — a statistically significant improvement (p<0.0001) that formed the basis of the FDA’s approval decision.

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