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Thursday, December 15 2022 - 00:00
Circulating Tumor Cell detection by Menarini Group's CELLSEARCH(R) System leading to genomic profiling of myeloma cells shows potential for non-invasive management of Multiple Myeloma patients at early stages of disease
Huntingdon Valley, PA, December 13, 2022, /PRNewswire-AsiaNet/--

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

/PRNewswire/ -- 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 

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(R) 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(R) platform and the CMMC test to stratify 

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(R) System coupled with the CELLSEARCH(R) 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(R) 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(R) 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, and Huntingdon Valley, Pa., U.S., is a wholly owned subsidiary 
of the Menarini Group, a multinational pharmaceutical, biotechnology and 
diagnostics company headquartered in Florence, Italy, with more than 17,000 
employees in 140 countries.


1 Dutta 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.

2 Ludwig 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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Source: Menarini Silicon Biosystems