Tinley Park, Illinois, August 19, 2026
Hematogenix has announced that its proprietary Multiple Myeloma Minimal Residual Disease (MM MRD) Next Generation Flow Cytometry assay supported the pivotal efficacy endpoint cited in the U.S. Food and Drug Administration’s accelerated approval of ZENBEXUS™ (iberdomide) from Bristol Myers Squibb. The approval marks ZENBEXUS as the first approved CELMoD therapy for multiple myeloma, while highlighting the growing importance of highly sensitive and standardized MRD testing in oncology clinical development. Hematogenix, a global specialty laboratory and contract research organization focused on oncology and hematopathology, said its assay was used to assess MRD-negative complete response in the Phase 3 EXCALIBER-RRMM study.
MRD Testing Provides Key Efficacy Evidence
The FDA-approved prescribing information for ZENBEXUS identifies MRD-negative complete response as the major efficacy outcome measure, assessed at a sensitivity threshold of 10⁻⁵ using a Hematogenix Next Generation Flow Cytometry assay. In the Phase 3 EXCALIBER-RRMM trial, patients receiving ZENBEXUS in combination with daratumumab and hyaluronidase-fihj and dexamethasone achieved an MRD-negative complete response rate of 41%, compared with 21% among patients receiving daratumumab, bortezomib and dexamethasone. The difference was statistically significant, with a reported p-value of less than 0.0001, and the MRD findings formed the basis of the accelerated approval decision. MRD negativity at the stated threshold represents detection of as few as one residual tumor cell among 100,000 normal cells, making sensitive laboratory methods particularly important for evaluating treatment response in multiple myeloma.
Hematogenix Expands Registrational Oncology Testing
The milestone reinforces Hematogenix’s role in providing registrational-grade oncology biomarkers and diagnostic testing for pharmaceutical sponsors. Its MM MRD platform is designed to support sensitive and reproducible assessment across multicenter clinical trials, while the company also offers MRD testing capabilities for diseases including acute myeloid leukemia (AML) and chronic lymphocytic leukemia (CLL). Hematogenix operates CAP-accredited and CLIA-certified laboratories in the United States, United Kingdom, Malaysia and China, supporting Phase 2 and Phase 3 development programs. The company said its specialized laboratory and CRO capabilities are intended to help sponsors generate reliable data for regulatory submissions and clinical decision-making. The use of its assay in the ZENBEXUS approval process illustrates how specialized flow cytometry technologies can contribute to modern precision oncology development, particularly as treatment programs increasingly evaluate deeper levels of response rather than relying solely on conventional disease measurements.
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ZENBEXUS Highlights Shift Toward Deeper Responses
ZENBEXUS is approved in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy that included a proteasome inhibitor and an immunomodulatory agent. The indication received accelerated approval based on MRD-negative complete response, meaning continued approval may depend on verification of clinical benefit in confirmatory trials. The development also demonstrates the increasing role of minimal residual disease assessment as an important endpoint in multiple myeloma research. For laboratories and clinical research organizations, standardized, sensitive and reproducible MRD methodologies can help provide the analytical foundation needed for evaluating investigational therapies and supporting regulatory-grade evidence. Hematogenix described the inclusion of its assay methodology in the FDA-approved prescribing information as an important validation of its laboratory capabilities. However, the company emphasized that its announcement concerns the assay methodology and does not constitute an endorsement by Bristol Myers Squibb. The approval and clinical use of ZENBEXUS remain subject to the product’s prescribing information, including its safety warnings and regulatory requirements.
Source: Hematogenix press relese
