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Menarini Silicon Biosystems Develops New Assay Workflow for Circulating Multiple Myeloma Cells

Technology to Be Introduced at the Molecular Medicine Tri-Conference May Offer Alternative to Invasive Bone Marrow Biopsy for Monitoring Disease Progression

Bologna, Italy and Huntingdon Valley, Pa., March 5, 2019 -- Menarini Silicon Biosystems, the pioneer of liquid biopsy technology, announced today that it will introduce a new semi-automated assay workflow utilizing the CELLSEARCH® and DEPArrayTM platforms to enumerate and characterize circulating multiple myeloma cells (CMMC) from peripheral blood samples.** 

Preliminary data to be presented at the Molecular Medicine Tri-Conference suggests that the ability to obtain CMMCs via liquid biopsy may enable clinical researchers to better understand tumor biology, particularly in early stage disease. In addition, this workflow could potentially offer a less invasive alternative to more expensive and painful bone marrow biopsy.

“The combined capabilities of CELLSEARCH together with our DEPArray system enhance our ability to enable meaningful advances in the field of personalized medicine,” said Bob Roda, President and CEO of Menarini Silicon Biosystems Inc. “We are advancing our technologies in order to help clinicians and researchers deepen their understanding of tumor progression.”

Menarini Silicon Biosystems offers the CELLSEARCH Circulating Multiple Myeloma Cell assay as a laboratory service.

A second presentation will examine the importance of obtaining pure cell populations for comprehensive molecular analysis and will introduce attendees to the DEPArrayTM FFPE SamplePrep Kit, which can be used for the disaggregation and staining of FFPE (formalin-fixed, paraffin-embedded) tissue sections down to a single-cell suspension.
The kit streamlines FFPE analysis by assembling all necessary reagents and providing a standardized protocol that is optimized for the DEPArray system. This offers a reduction in total sample prep time while also reducing user variability in obtaining 100% pure tumor cell populations - which can improve downstream molecular analysis.

“We’re committed to working in partnership with those in the personalized medicine field and give them the solutions that will help quicken the pace of discovery,” said Roda.

CELLSEARCH is the first and only clinically validated blood test cleared by the FDA for detecting and enumerating circulating tumor cells (CTCs) as an aid for physicians to manage patients with metastatic breast, prostate and colorectal cancers.* The DEPArray System is the first technology to combine microfluidics with microelectronics and microscopy to isolate and manipulate individual cells for research use. It is the only image-based sorting and isolation platform that enables clinical researchers to facilitate molecular analyses on live or fixed cells with single-cell precision.

Presentation Details:

Tuesday, March 12 - Circulating Tumor Cells and Liquid Biopsy Program
Session: CTCs and Liquid Biopsy – New Window into Selecting Best Treatment for Patients

Title: Exploring the Molecular Heterogeneity of Individual Circulating Cells Using CELLSEARCH and DEPArray Technologies in Multiple Myeloma and Other Cancers
Presented by: Steven Gross, MSc, head of CELLSEARCH Assay Development for Menarini Silicon Biosystems
Time: 11:55 am, Location: Room 8, Moscone South Convention Center

Tuesday, March 12 - Precision Medicine Program
Session: Personalized Strategies for Immunotherapy

Title: Precision Analysis of FFPE Samples using DEPArray Technology
Presented by: Arielle Ginsberg, MSc, Scientific Affairs Liaison for Menarini Silicon Biosystems
Time: 3:40 pm. Location: Room 105, Moscone South Convention Center

To learn more about the CELLSEARCH and DEPArray Systems, MMTC attendees can visit Menarini Silicon Biosystems at Booth #501.
The 26th International Molecular Medicine Tri-Conference will be held March 10-15, 2019 in San Francisco.

About Menarini Silicon Biosystems
Menarini Silicon Biosystems, based in Bologna, Italy, and Huntingdon Valley (PA), USA, develops innovative technologies and products that help researchers understand the biological complexity of disease through the study of single cells. The company manufactures and markets the DEPArrayTM NxT, the only image-based digital cell-sorting and isolation platform that enables clinical researchers to conduct molecular analyses on live or fixed cells with single-cell precision. In 2017 Menarini Silicon Biosystems purchased all the assets and relevant business related to the CELLSEARCH® Circulating Tumor Cell (CTC) System. The integration of CELLSEARCH® and DEPArray provides an end-to-end workflow solution** for the enumeration, isolation, and molecular characterization of CTCs from a simple blood test in the clinical research setting. This will help drive the clinical utility and correlation of CTCs with the effectiveness of specific therapies. Menarini Silicon Biosystems is a wholly owned subsidiary of the Menarini Group, a multinational pharmaceutical, biotechnology and diagnostics company headquartered in Florence, Italy, with a heritage of over 130 years and over 17,000 employees in more than 100 countries.

*For more information on the full intended use and limitations of CELLSEARCH system, please refer to the Instructions for Use on http://documents.cellsearchctc.com/.
**The workflow described is for research use only. Not for use in diagnostic procedures. The performance characteristics, safety, and effectiveness of the workflow have not been established and are not cleared or approved by the FDA.