Circulating Tumor Cell detection by Menarini Group's CELLSEARCH® System leading to genomic profiling of myeloma cells shows potential for non-invasive management of Multiple Myeloma patients at early stages of disease

Researchers at Dana-Farber Cancer Instituteshowed that enumeration of circulating tumor cells (CTCs) with Menarini Silicon Biosystems' CELLSEARCH® System and the CELLSERCH® Circulating Multiple Myeloma Cell (CMMC) Test* can be usedto monitor and manage patients with Multiple Myeloma (MM) even at asymptomatic precursor stages

HUNTINGDON VALLEY,Pa.,Dec. 14,2022 -- Menarini Silicon Biosystems,a pioneer of liquid biopsy and single cell technologies,announced today the results of a study in which enumeration and genomic characterization of CTCs at varying stages of MM represents an invaluable tool to predict disease aggressiveness and pathology. This study was conducted in collaboration with Dana-Farber Cancer Institute researchers and published on December 7,2022 in Cancer Discovery1.

According to Irene Ghobrial,MD,Director of the Clinical Investigator Research Program at Dana-Farber Cancer Institute,Boston,and senior author of the study "this new data represents another great milestone,both for our understanding of MM and abilities to prevent disease progression". Dr Ghobrial was recently awarded the William Dameshek Prize,an award that is given annually by the American Society of Hematology (ASH) for outstanding contributions in hematology.

MM accounts for 10% of hematological malignancies and has a current worldwide incidence level of 160,0002. This type of blood cancer forms in plasma cells (PCs) located in the bone marrow (BM). Asymptomatic precursor stages such as monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM) can be highly heterogeneous in terms of their risk of progression and the lack of tools to monitor this population represents a critical unmet medical need. Current standard of care involves invasive BM biopsies to understand disease pathology and decide on treatment strategies. The CELLSEARCH® platform's ability to enrich,capture and isolate MM CTCs within a 4ml blood sample,enables clinicians to leverage a minimally invasive diagnostic procedure for regular monitoring of patients.

Findings from this novel and robust proof-of-concept study were based on CTCs from 261 patients (84 MGUS,155 SMM and 22 MM). The majority of precursor patients analyzed in the study showed evidence of CTCs,with one or more CTCs detected in 82% of the overall enrolled population-. In addition,the data showed an increase in the number of CTCs from MGUS to SMM,confirming the correlation between a higher disease burden and greater trafficking of CTCs. The Kaplan Meier analysis over a median follow-up time of 27 months,showed that SMM patients with CTCs (≥ 1 per 4mL of blood) had a higher probability of progression to MM (P=0.03). These data underline the value of CTC enumeration using the CELLSEARCH® platform and the CMMC test to stratify risk.

The study also demonstrated that a comprehensive genomic characterization of CTCs based on the Minimally Invasive Multiple Myeloma sequencing (MinimuMM-seq)** process enabled the detection of translocations and copy number abnormalities through whole-genome sequencing of highly pure CTCs. These analyses showed that the myeloma cells captured in the blood compartment showed an identical genomic architecture to those located in the BM,thus enabling disease monitoring over time without having to extract serial bone aspirates. The CELLSEARCH® System coupled with the CELLSEARCH® CMMC test* provides a simple approach to capturing myeloma cells,enumerate them and apply MinimuMM-seq to extract the maximum genetic information from each cell**.

"We reached yet another milestone on our quest to provide an alternative method to invasive and painful BM biopsies for MM which can have a transformative effect on how patients even with asymptomatic forms of disease can be managed moving forward" said Elcin Barker Ergun,CEO of Menarini Group.

"We are thrilled to offer the CELLSEARCH® CMMC test* as a laboratory developed test (LDT) in the US and help professionals in the field of hematology,by providing a tool to monitor disease progression in real time," said Fabio Piazzalunga,President and CEO of Menarini Silicon Biosystems. "This minimally invasive approach to capturing myeloma cells in blood,is not only important to identify patients at higher risk of progression but reduces the need for bone marrow biopsies."

Menarini Silicon Biosystems CELLSEARCH® CMMC test* is available as a laboratory developed test (LDT) in MSB's CLIA/CAP/ ISO 15189 accredited laboratory in Huntingdon Valley,Pa.

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.

References

1Dutta A,Alberge J-B,et al,MinimuMM-seq: Genome sequencing of circulating tumor cells for minimally invasive molecular characterization of multiple myeloma pathology,Cancer Discov CD-22-0482.

2Ludwig H,Novis Durie S,Meckl A,Hinke A,Durie B. Multiple Myeloma Incidence and Mortality Around the Globe; Interrelations Between Health Access and Quality,Economic Resources,and Patient Empowerment. Oncologist. 2020 Sep;25(9): e1406-e1413. doi: 10.1634/theoncologist.2020-0141. Epub 2020 May 7. PMID: 32335971; PMCID: PMC7485361.

* The Circulating Multiple Myeloma Cell (CMMC) test is a CLIA-accredited laboratory developed test from Menarini Silicon Biosystems in USA. The performance characteristics and safety and effectiveness have not been established and are not cleared or approved by the FDA.

**For Research use only. Not to be used in diagnostic procedures.The performance characteristics and safety and effectiveness have not been established and are not cleared or approved by the FDA.

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