PR93363

BOLOGNA, Italy and HUNTINGDON VALLEY, Pa., Nov. 30, 2021 /PRNewswire=KYODO JBN/ --

As the market leader in cell-based liquid biopsies, Menarini Silicon Biosystems

is offering community hematology-oncologists an opportunity to have patient

blood samples sent to a US centralized laboratory where its CELLSEARCH(R)  

technology can enumerate Circulating Multiple Myeloma Cells (CMMCs) for

non-invasive monitoring of disease

Menarini Silicon Biosystems (MSB), a pioneer of liquid biopsy and single cell

technologies, announced today the commercial launch of its CELLSEARCH(R)

Laboratory Developed Test (LDT) for enumeration of CMMCs from whole blood. This

commercial, CLIA-validated assay meets the certification standards of The

Centers for Medicare and Medicaid Services. MSB's new LDT provides community

physicians with an opportunity to identify at-risk patients and gain early

information on disease progression.  

The CELLSEARCH(R) Circulating Multiple Myeloma Test is non-invasive and an

effective longitudinal monitoring tool with less patient discomfort, compared

to the current standard of care, based on costly and painful bone marrow

biopsies.

Multiple Myeloma (MM) is the second most common hematological cancer in the US

and is often asymptomatic in the initial stages. Data have shown that CMMCs can

represent useful biomarkers of disease status and pathogenesis. Their numbers

are increased in the peripheral blood of MM patients along within the two

precursor diseases: Monoclonal Gammopathy of Undetermined Significance (MGUS)

and Smoldering Multiple Myeloma (SMM)

According to Foulk et al., "CMMC can be used to study disease biology and

monitor clinical disease progression through a blood draw. The non-invasive,

easily standardized nature of the CMMC assay makes it particularly attractive

during earlier stages of MM progression, such as SMM, and at later disease

stages when a bone marrow aspirate is not desirable."  

The CELLSEARCH(R) System has demonstrated consistent, reproducible results over

several decades. Previously, it was available mainly to academic institutions

and pharmaceutical companies. This unique technology is now accessible to

community physicians throughout the US.

Fabio Piazzalunga, President and CEO of Menarini Silicon Biosystems, commented

"This is a major milestone for our company and shows the intrinsic value of our

CELLSEARCH(R) technology, capable of measuring circulating tumor cells in

various cancer settings. We have other CTC biomarker liquid biopsies for

specific malignancies that are already underway as LDTs and we are proud of the

information they will offer to improve patient care."

MSB's expertise in making circulating tumor cells more accessible comes at a

timely moment for the MM community. A high degree of correlation between the

CELLSEARCH(R) Circulating Multiple Myeloma Test and disease burden has been

established, raising the possibility of a metric for minimal residual disease

(MRD) or relapse in a patient population with an unmet clinical need.

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 FDA cleared

CELLSEARCH(R) circulating cell capture, enrichment and enumeration platform.

The US Lab is CLIA Certified and ISO 15189 Accredited for CELLSEARCH(R). This

lab has a strong track record of success in quality, regulatory and

pharmaceutical company audits.

About Menarini Silicon Biosystems

MSB offers unique rare cell technologies and solutions that provide clinicians

and clinical researchers with access to unparalleled data on rare 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.siliconbiosystems.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.

Linda PAVY – lipavy@pavyconsulting.com

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Source: Menarini Silicon Biosystems