BOLOGNA, Italy and HUNTINGDON VALLEY, Pa., Nov. 30, 2021 /PRNewswire/ -- Menarini Silicon
Biosystems (MSB), a pioneer of liquid biopsy and single cell
technologies, announced today the commercial launch of its
CELLSEARCH® 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® 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® 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®
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®
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®
circulating cell capture, enrichment and enumeration platform.
The US Lab is CLIA Certified and ISO 15189 Accredited for
CELLSEARCH®. 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, 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