Hematogenix称其MM MRD检测方法被用于BMS多发性骨髓瘤新药ZENBEXUS获批标签

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.
"Being named directly in the FDA label for the first approved therapy in a novel drug class is a meaningful validation of the precision and scientific rigor our laboratory brings to this new era of innovative therapies," said Dr. Hytham Al-Masri, President and CEO of Hematogenix. "Multiple myeloma treatment is moving toward MRD negativity as a defining measure of treatment success, and we are proud that our MM MRD flow cytometry platform is trusted to generate the data that regulators, physicians, and patients relying upon."
MRD negativity, measured at a sensitivity threshold of one residual tumor cell among 100,000 normal cells, is increasingly recognized by regulatory authorities as a surrogate endpoint capable of supporting accelerated approval pathways in multiple myeloma, a use case for which specialized, standardized assay methodology is essential. Hematogenix's NGF MRD platform for MM, AML and CLL is designed to meet the sensitivity, reproducibility, and regulatory-grade standards required for these registrational endpoints across sponsors' global multicenter trial sites.
This milestone reflects Hematogenix's broader positioning as an agile, specialized reference laboratory and CRO supporting registrational-grade endpoints for major pharmaceutical sponsors, with CAP-accredited and CLIA certified laboratories across the globe, including the United States, United Kingdom, Malaysia, and China.
About ZENBEXUS™ (iberdomide) ZENBEXUS is indicated, in combination with daratumumab and hyaluronidase-fihj and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. This indication is approved under accelerated approval based on MRD-negative complete response at any time; continued approval may be contingent upon verification of clinical benefit in confirmatory trials. ZENBEXUS carries a Boxed Warning for embryo-fetal toxicity and serious venous and arterial thromboembolism and is available only through the ZENBEXUS REMS program. Full prescribing information, including additional warnings and precautions, is available from Bristol Myers Squibb.
About Hematogenix Hematogenix is a global specialty oncology and hematopathology reference laboratory and contract research organization. Hematogenix operates , CAP-accredited and CLIA certified laboratories in the United States, United Kingdom, Malaysia, and China, supporting major pharmaceutical sponsors across Phase 2 and Phase 3 registrational studies with specialized diagnostic and biomarker assay capabilities.
ZENBEXUS™ is a trademark of Bristol Myers Squibb.
This release describes an assay methodology cited in the FDA-approved prescribing information for ZENBEXUS™ (iberdomide). It does not constitute an endorsement by Bristol Myers Squibb, and all clinical data regarding ZENBEXUS, including safety and efficacy information, should be referenced from the official prescribing information.
Media Inquiries: Hematogenix Laboratory Services | [email protected]
SOURCE Hematogenix