Developing a Novel Assay for Circulating Multiple Myeloma Cells Using the CELLSEARCH Platform

Multiple Myeloma is the second most prevalent hematological cancer in the United States, with approximately 30,000 new cases a year. At present, the disease remains incurable with a 5-year survival rate of 51%. To aid in the understanding of the biology of multiple myeloma and monitor clinical progression of the disease, a novel research use only (RUO) assay was developed using the CELLSEARCH^® system to  enumerate circulating multiple myeloma cells (CMMC) from peripheral blood.

A published patient study using the RUO CELLSEARCH^® CMMC assay has shown that CMMC counts correlated with clinical measures of disease burden, including percentage of bone marrow plasma cells, serum M protein, and International Staging System stage. Patients with CMMC counts ≧ than 100 in 4 mL blood during remission had worse progression-free survival compared with patients who had less than 100. A subset of smoldering multiple myeloma (SMM) patients showed that higher patient CMMC counts were associated with higher-risk myeloma states. This demonstrates the power of enumerating circulating MM cells as a potential marker for disease progression and stage in a minimally-invasive assay.

Join us for a discussion by Steve Gross, the creator of this innovative liquid biopsy assay, to learn more about the development process, and Dr. Irene Ghobrial from the Dana-Farber Cancer Institute, on the assay’s clinical application. In addition, Sara Lazaro, Head of Clinical Lab Operations and Services, will discuss the benefits of pharma and biotech utilizing the CMMC assay lab offering to enhance their research into Multiple Myeloma and drug response.

The CELLSEARCH^® CMMC assay is for Research Use Only. Not for use in Diagnostic Procedures.  This CELLSEARCH^® to DEPArray™ workflow described is for Research Use Only.

The integration of CELLSEARCH^® and DEPArray™ technologies provide an end-to-end workflow solution for the enumeration, isolation, and molecular characterization of CTCs in liquid biopsy.

Speakers

Dr. Irene Ghobrial, M.D., DFCI, Director, Clinical Investigator Research Program at Dana-Farber Cancer Institute

Dr. Irene Ghobrial is a Professor of Medicine at Dana-Farber Cancer Institute, Harvard Medical School, and the Lavine Family Chair for Preventative Cancer Therapies. She is also an Associate Member of the Broad Institute of the Massachusetts Institute of Technology (MIT) and Harvard. She is the Director of the Clinical Investigator Research Program at DFCI, Director of Translational Research in the Department of Multiple Myeloma, and Director of the Center for Prevention of Progression diseases (CPOP) and co-leader of the Dana-Farber Harvard Cancer Center Lymphoma and Myeloma Program. Her laboratory and clinical studies thus focus on identifying and developing effective therapeutic interventions for precursor conditions of myeloma (Monoclonal Gammopathy of Undetermined Significance and Smoldering Multiple Myeloma, MGUS and SMM). The focus of her research is to identify novel biomarkers of disease progression and help develop potentially curative therapies in the pre-malignant phase that exploit the immune microenvironment in the bone marrow. Dr. Ghobrial has over 250 publications in many prestigious journals and has presented and led many national and international meetings on myeloma.

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Steven Gross, Head of Assay Development, Menarini Silicon Biosystems

Steven Gross is the Head of Assay Development for Menarini Silicon Biosystems. As a Scientist/Senior Scientist, he has been a part of the CELLSEARCH story from its founding at Immunicon Corporation, then with Johnson & Johnson, and now Menarini Silicon Biosystems. In addition to executing R&D research agreements and assay development, he works closely with both the clinical and commercial teams to supply reagents for clinical lab services and interact with research partners and customers.

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Sara Lazaro, Head of Clinical Lab Operations and Services, Menarini Silicon Biosystems

Sara Lazaro has broad and extensive experience in setting, managing, and coordinating operations in different types of industries. She currently leads the Clinical Laboratories in both Huntingdon Valley, PA (US) and Bologna (Italy) Menarini Silicon Biosystems. Most recently, Lazaro was Director of Operations at Dermpath Diagnostics, a division of Quest Diagnostics, in New York. Over the past decade she has managed laboratories at Myriad Genetics and the Cincinnati Children’s Hospital Medical Center, both with emphasis in genetics and molecular operations. She earned her MBA from the University of Cincinnati and a bachelor’s degree and a Master of Biological Sciences at the Autonomous University of Madrid.

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