The brand new take a look at, obtainable as a Lab Service all through Europe and US, leverages the Gold Normal CELLSEARCH platform to enumerate Circulating A number of Myeloma Cells from blood and provides real-time standardized monitoring of a number of myeloma in medical analysis research.
BOLOGNA, Italy and HUNTINGDON VALLEY, Pa., March 31, 2021 /PRNewswire/ — Menarini Silicon Biosystems, a pioneer of liquid biopsy and single cell applied sciences, introduced at this time the launch of a brand new assay to fulfill the wants of pharma corporations, CROs, clinicians and analysis scientists engaged on a number of myeloma (MM). This new CELLSEARCH® Circulating A number of Myeloma Cells (CMMCs) Assay* captures and enumerates CMMCs from peripheral blood. It has the potential to scale back invasive, usually painful, and expensive bone marrow (BM) biopsies to watch in real-time MM evolution and research illness biology. Its availability throughout Europe and the US will permit for elevated information consistency throughout worldwide multicenter MM trials.
MM is the second most typical blood most cancers. All through their medical journey, sufferers are topic to repeat BM biopsies, to diagnose and monitor illness standing. An unmet medical want in all MM levels is to have a non-invasive modality for prognosis and monitoring of illness development, offering the general actionable data presently obtainable from BM biopsies.
CMMCs are elevated within the peripheral blood of sufferers with MM and in sufferers with two precursor illnesses: monoclonal gammopathy of unknown significance (MGUS) and smoldering a number of myeloma (SMM)1. Furthermore, a excessive diploma of correlation between CELLSEARCH CMMC counts and illness burden in myeloma sufferers has been proven, elevating the potential of utilizing CMMC counts as a metric for minimal residual illness or relapse in medical trials1.
In line with Ana Slipicevic, Translational Analysis Director at Oncopeptides AB, “the CMMC take a look at, with a non-invasive sampling process, for which peripheral blood drawn may be saved for as much as 96 hours at room temperature, has proven to be a dependable and reproducible assay to watch illness standing. It has allowed us to avoid wasting time in gaining fast entry to top quality research information”. The brand new assay provides vital standardization and sensitivity to watch and perceive MM illness.
“We’re excited to current to trade researchers, academia and organizations, our new CMMC Assay that’s displaying nice promise to watch MM illness and precursor states by way of a non-invasive liquid biopsy,” stated Fabio Piazzalunga, President and CEO of Menarini Silicon Biosystems. “The chance, to additional isolate these cells with the DEPArray platform and carry out molecular analyses, permits to detect the precise molecular modifications that happen all through the illness development, which is able to doubtless have therapeutic implications for this dynamic hematological dysfunction.”
About Menarini Silicon Biosystems Lab Providers
The Menarini Silicon Biosystems (MSB) Lab Providers characterize a world, complete and built-in laboratory service involving state-of-the-art applied sciences. It builds on MSB’s built-in workflow together with the CELLSEARCH® circulating cell seize, enumeration and enrichment platform and the DEPArrayTM cell sorting system, which allows single cell molecular evaluation.
The US Lab is CLIA Licensed and ISO 15189 Accredited for CELLSEARCH. The Mirror Lab in Bologna Italy shares the identical High quality Administration System with ISO15189 accreditation anticipated in 2021. Collectively these labs account for over 25 partnerships encompassing 60 medical trials and greater than 25,000 samples. They’ve a robust observe document of success in high quality, regulatory and pharmaceutical firm audits.
For extra details about MSB Lab Providers, please consult with https://www.cellsearchruo.com/crs-services/cmmc-assay.
About Menarini Silicon Biosystems (MSB)
MSB provides distinctive uncommon cell applied sciences and options that present medical researchers with entry to unparalleled decision within the research of cells and their molecular characterization.
Menarini Silicon Biosystems, based mostly in Bologna, Italy, and Huntingdon Valley, Pa., U.S., is a completely owned subsidiary of the Menarini Group, a multinational pharmaceutical, biotechnology and diagnostics firm headquartered in Florence, Italy, with greater than 17,000 staff in 140 international locations.
* For analysis use solely. Not to be used in diagnostic procedures. The efficiency, traits, security, and effectiveness haven’t been established and will not be cleared or authorized by the FDA.
- Foulk B et al. Enumeration and characterization of circulating a number of myeloma cells in sufferers with plasma cell problems. Br J Haematol. 2018 Jan;180(1):71-81.
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SOURCE Menarini Silicon Biosystems