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Multiple Myeloma

Multiple Myeloma

The first standardized liquid biopsy assay to monitor multiple myeloma disease status

Multiple Myeloma is the second most common blood cancer. Throughout their clinical journey, patients are subject to repeated bone marrow biopsies, both to diagnose and monitor disease status. An unmet medical need in all multiple myeloma stages is to have a non-invasive modality for diagnosis and monitoring of disease progression, providing the overall actionable information currently available from bone marrow biopsies.

Menarini Silicon Biosystems offers the new CELLSEARCH Circulating Multiple Myeloma Cell (CMMC) Enumeration assay, the first-of-its-kind, which directly measures levels of plasma cells in peripheral blood.

 

CMMCs are increased in the peripheral blood of patients with multiple myeloma and two precursor diseases: monoclonal gammopathy of unknown significance (MGUS) and smoldering multiple myeloma (SMM)1. Moreover, a high degree of correlation between CELLSEARCH CMMC counts and disease burden in myeloma patients has been shown, raising the possibility of using CMMC counts as a metric for minimal residual disease or relapse in clinical trials1.

The CELLSEARCH CMMC enumeration test provides new, complementary information to that of the bone marrow biopsy and other standard-of-care measures. Due to its minimally invasive nature, it can be performed serially to assess plasma cell burden without requiring repeated bone marrow biopsies.

 

In the US, the test is available for physicians as a Laboratory-Developed Test (LDTs)* for patient management or for biopharma and clinical trials research as a CLIA-certified test. 

The test** is available for biopharma research across Europe as a research lab service.

 

The proprietary CellRescue™ blood collection tubes stabilize CMMCs at room temperature for up to 120 hours, allowing samples to be sent to centralized facilities. The broad availability of the test can offer increased data consistency during international multicenter multiple myeloma trials.

*This Circulating Multiple Myeloma Cell assay for CELLSEARCH® has not been cleared or approved by the FDA. In the US only it is available as a commercial, CLIA-approved assay that meet the certification standards of The Centers for Medicare and Medicaid Services.

**For Research use only.

Reference

  1. Foulk B et al. Enumeration and characterization of circulating multiple myeloma cells in patients with plasma cell disorders. Br J Haematol. 2018 Jan;180(1):71-81.