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Hematogenix MRD Assay Used in FDA Approval of ZENBEXUS for Myeloma

Published

31 August 2026

Topic

opportunities

Sectors

Biotech

Geography

United States

Source

Read at clpmag.com

Verified

Fusion42 · 31 August 2026 · Fusion42 review

Hematogenix's next generation flow cytometry assay was the analytical method supporting the FDA accelerated approval of Bristol Myers Squibb's ZENBEXUS for multiple myeloma, marking the first approval of a CELMoD therapy. The assay measured MRD-negative complete response, a primary efficacy endpoint, validating its role in regulatory approval pathways for cancer therapies.

This Wire brief sits within Fusion42's coverage of Biotech.

◆ The Wire takeaway

Your biotech firm faces a new regulatory benchmark with MRD assays now pivotal in FDA approvals. Integrate or partner quickly, or your clinical diagnostics could fall behind in shaping cancer treatment adoption.

Coverage

1 source · 31 Aug 2026

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Biotechmrd-assayfda-approvalmultiple-myelomacelmodflow-cytometry