Menarini Silicon Biosystems launches CELLSEARCH® Circulating Multiple Myeloma Cells Assay, a new non-invasive test to monitor disease status in clinical research studies

BOLOGNA,Italy and HUNTINGDON VALLEY,Pa.,March 31,2021 --Menarini Silicon Biosystems,a pioneer of liquid biopsy and single cell technologies,announced today the launch of a new assay to meet the needs of pharma companies,CROs,clinicians and research scientists working on multiple myeloma (MM). This new CELLSEARCH® Circulating Multiple Myeloma Cells (CMMCs) Assay* captures and enumerates CMMCs from peripheral blood. It has the potential to reduce invasive,often painful,and costly bone marrow (BM) biopsies to monitor in real-time MM evolution and study disease biology. Its availability across Europe and the US will allow for increased data consistency during international multicenter MM trials.

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

CMMCs are increased in the peripheral blood of patients with MM and in patients with 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.

According to Ana Slipicevic,Translational Research Director at Oncopeptides AB,"the CMMC test,with a non-invasive sampling procedure,for which peripheral blood drawn can be stored for up to 96 hours at room temperature,has shown to be a reliable and reproducible assay to monitor disease status. It has allowed us to save time in gaining rapid access to high quality study data". The new assay offers significant standardization and sensitivity to monitor and understand MM disease.

"We are excited to present to industry researchers,academia and organizations,our new CMMC Assay that is showing great promise to monitor MM disease and precursor states through a non-invasive liquid biopsy," said Fabio Piazzalunga,President and CEO of Menarini Silicon Biosystems. "The possibility,to further isolate these cells with the DEPArray platform and perform molecular analyses,allows to detect the specific molecular changes that occur throughout the disease progression,which will likely have therapeutic implications for this dynamic hematological disorder."

About Menarini Silicon Biosystems Lab Services

The Menarini Silicon Biosystems (MSB) Lab Services represent a global,comprehensive and integrated laboratory service involving state-of-the-art technologies. It builds on MSB's integrated workflow including the CELLSEARCH® circulating cell capture,enumeration and enrichment platform and the DEPArrayTM cell sorting system,which enables single cell molecular analysis.

The US Lab is CLIA Certified and ISO 15189 Accredited for CELLSEARCH. The Mirror Lab in Bologna Italy shares the same Quality Management System with ISO15189 accreditation expected in 2021. Together these labs account for over 25 partnerships encompassing 60 clinical trials and more than 25,000 samples. They have a strong track record of success in quality,regulatory and pharmaceutical company audits.

For more information about MSB Lab Services,please refer to https://www.cellsearchruo.com/crs-services/cmmc-assay.

About Menarini Silicon Biosystems (MSB)

MSB offers unique rare cell technologies and solutions that provide clinical researchers with access to unparalleled resolution in the study of cells and their molecular characterization.

Menarini Silicon Biosystems,based in Bologna,Italy,andHuntingdon Valley,U.S.,is a wholly owned subsidiary of the Menarini Group,a multinational pharmaceutical,biotechnology and diagnostics company headquartered inFlorence,with more than 17,000 employees in 140 countries.

* For research use only. Not for use in diagnostic procedures. The performance,characteristics,safety,and effectiveness have not been established and are not cleared or approved by the FDA.

Reference

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.

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Linda Pavy - linda.pavy@bcw-global.com