Menarini Silicon Biosystems launches CELLSEARCH(R) Circulating Multiple Myeloma Cells Assay, a new non-invasive test to monitor disease status
Menarini Silicon Biosystems launches CELLSEARCH(R) Circulating Multiple Myeloma Cells Assay, a new non-invasive test to monitor disease status in clinical research studies
BOLOGNA, Italy and HUNTINGDON VALLEY, Pa., March 31, 2021 /PRNewswire-AsiaNet/ --
-- The new test, available as a Lab Service throughout Europe and US, leverages
the Gold Standard CELLSEARCH platform to enumerate Circulating Multiple Myeloma
Cells from blood and offers real-time standardized monitoring of multiple
myeloma in clinical research studies.
Menarini Silicon Biosystems, a pioneer of liquid biopsy and single cell
technologies, announced today the launch of a new assay to meet the needs of
pharma companies, CROs, clinicians and research scientists working on multiple
myeloma (MM). This new CELLSEARCH(R) Circulating Multiple Myeloma Cells (CMMCs)
Assay* captures and enumerates CMMCs from peripheral blood. It has the
potential to reduce invasive, often painful, and costly bone marrow (BM)
biopsies to monitor in real-time MM evolution and study disease biology. Its
availability across Europe and the US will allow for increased data consistency
during international multicenter MM trials.
Logo - https://mma.prnewswire.com/media/1362208/Menarini_Logo.jpg
MM is the second most common blood cancer. Throughout their clinical journey,
patients are subject to repeat BM biopsies, to diagnose and monitor disease
status. An unmet medical need in all MM stages is to have a non-invasive
modality for diagnosis and monitoring of disease progression, providing the
overall actionable information currently available from BM biopsies.
CMMCs are increased in the peripheral blood of patients with MM and in patients
with two precursor diseases: monoclonal gammopathy of unknown significance
(MGUS) and smoldering multiple myeloma (SMM)(1). Moreover, a high degree of
correlation between CELLSEARCH CMMC counts and disease burden in myeloma
patients has been shown, raising the possibility of using CMMC counts as a
metric for minimal residual disease or relapse in clinical trials(1).
According to Ana Slipicevic, Translational Research Director at Oncopeptides
AB, "the CMMC test, with a non-invasive sampling procedure, for which
peripheral blood drawn can be stored for up to 96 hours at room temperature,
has shown to be a reliable and reproducible assay to monitor disease status. It
has allowed us to save time in gaining rapid access to high quality study
data". The new assay offers significant standardization and sensitivity to
monitor and understand MM disease.
"We are excited to present to industry researchers, academia and organizations,
our new CMMC Assay that is showing great promise to monitor MM disease and
precursor states through a non-invasive liquid biopsy," said Fabio Piazzalunga,
President and CEO of Menarini Silicon Biosystems. "The possibility, to further
isolate these cells with the DEPArray platform and perform molecular analyses,
allows to detect the specific molecular changes that occur throughout the
disease progression, which will likely have therapeutic implications for this
dynamic hematological disorder."
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
CELLSEARCH(R) circulating cell capture, enumeration and enrichment platform and
the DEPArray(TM) cell sorting system, which enables single cell molecular
analysis.
The US Lab is CLIA Certified and ISO 15189 Accredited for CELLSEARCH. The
Mirror Lab in Bologna Italy shares the same Quality Management System with
ISO15189 accreditation expected in 2021. Together these labs account for over
25 partnerships encompassing 60 clinical trials and more than 25,000 samples.
They have a strong track record of success in quality, regulatory and
pharmaceutical company audits.
For more information about MSB Lab Services, please refer to
https://www.cellsearchruo.com/crs-services/cmmc-assay.
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.
* For research use only. Not for use in diagnostic procedures. The performance,
characteristics, safety, and effectiveness have not been established and are
not cleared or approved by the FDA.
Reference
1. Foulk B et al. Enumeration and characterization of circulating multiple
myeloma cells in patients with plasma cell disorders. Br J Haematol. 2018
Jan;180(1):71-81.
Linda Pavy - linda.pavy@bcw-global.com
SOURCE Menarini Silicon Biosystem
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