PR99198

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=KYODO JBN/--

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

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(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

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(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

[https://c212.net/c/link/?t=0&l=en&o=2974193-1&h=2883067015&u=http%3A%2F%2Fwww.s

iliconbiosystems.com%2F&a=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.

References

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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Media Contact

Linda PAVY

lipavy@pavyconsulting.com

Source: Menarini Silicon Biosystems