Le Lézard
Classified in: Health, Science and technology, Business
Subjects: PDT, TRI

New CELLSEARCH® Circulating Multiple Myeloma Test now available to help community physicians optimize patient care

BOLOGNA, Italy and HUNTINGDON VALLEY, Pa., Nov. 30, 2021 /CNW/ -- 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. 

Menarini Logo

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

Logo - https://mma.prnewswire.com/media/1362208/Menarini_Logo.jpg

SOURCE Menarini Silicon Biosystems

These press releases may also interest you

at 03:30
CloudSmartz and LastMileXchange (LMX) today announced a strategic partnership to help Communication Service Providers (CSPs) accelerate digital transformation (DX) and rapidly improve customer experience (CX). CloudSmartz is a provider of one of the...

at 03:30
The GSMA has published an analysis showing how robust 5G growth in the Middle East and North Africa has followed ambitious 5G spectrum assignments. As governments worldwide strive towards realising industry targets of 2GHz of mid-band spectrum for...

at 03:30
AI-powered digital skills assessment platform, iMocha, today announced a $14 million Series A investment round led by Eight Roads Ventures, with participation from existing investors Upekkha and Better Capital. Aditya Systla from Eight Roads Ventures...

at 03:05
Bragg Gaming Group , ("Bragg" or "The Company") has today announced the launch in several European iGaming markets of Egyptian Magic, the debut title from Atomic Slot Lab, the Company's new game development studio with a mission to deliver a superior...

at 03:05
ADVA today announced that Terralpha has deployed its FSP 3000 TeraFlextm terminal to transport data at speeds up to 600Gbit/s between cities across France. The solution enables Terralpha ? the new service provider arm of France's SNCF railway group...

at 03:01
Highspot, the sales enablement platform that increases the performance of sales teams, today announced soaring customer adoption as organisations worldwide turn to sales enablement to drive revenue. Over the last year, Highspot connected more than...

News published on 30 november 2021 at 08:17 and distributed by: