Menarini Silicon Biosystems To Announce New Solutions for Advancing Liquid Biopsy in Clinical Research

BOLOGNA, ITALY AND HUNTINGDON VALLEY, PA - Feb 27, 2020 - Menarini Silicon Biosystems, the pioneer of liquid biopsy and rare cell technologies, announced today that it is developing several new products that could help advance precision medicine research by expanding the capabilities and applications of its CELLSEARCH and DEPArray technologies, for rare cells isolation and single cell analysis.

The new solutions include an assay for the enumeration and molecular characterization of circulating multiple myeloma cells (CMMC) from peripheral blood samples, the DEPArray™system upgraded to 9 colors and artificial intelligence software.

The company’s technological developments will be highlighted during a presentation by Mark Connelly, PhD, Chief Research and Development Officer at Menarini Silicon Biosystems Inc, as part of the Molecular Medicine Tri-Conference’s Circulating Tumor Cells & Liquid Biopsy track.

“We are continually working to develop additional tools that will facilitate the exploration of new areas of inquiry,” said Connelly. “Providing researchers with more information from a wider variety of cell populations and the ability to examine tumor heterogeneity in real-time could help address some critical questions in pharmaceutical and clinical research.”

The CMMC assay based on the capabilities of CELLSEARCH® to enrich and enumerate rare cells allow researchers to monitor the number of CMMCs in peripheral blood; furthermore when combined with the DEPArray™ system, will allow to perform molecular analysis at single cell level**. Research suggests that the ability to obtain CMMCs via liquid biopsy may help clinical researchers to better monitor disease state and treatment response, though, not only the cell enumeration but also the real time cell molecular profiling.  Menarini Silicon Biosystems currently offers a CMMC assay (Research Use Only) as a service through its Global Laboratory Services. The company plans to release the assay for Research Use Only in the summer of 2020.

The 9-Color DEPArray will offer more fluorescence channels to examine the heterogeneity of markers expression on various rare cells, enabling researchers to simultaneously identify and characterize multiple cell populations. The artificial intelligence software will reduce operator variability by automating cell identification and selection and will help researchers move beyond enumeration to unravel hidden information in the cell image data.

Connelly’s presentation will also feature new research supporting the potential use of CTCs as a response biomarker for prostate cancer treatment. A 2018 study published in the Journal of Clinical Oncology indicates that using CTC counts obtained from liquid biopsy after 13 weeks of treatment can provide an accurate assessment of response to treatment. PSA (prostate-specific antigen) is one of the only markers currently available for the disease but is not considered to be a sufficient indicator of treatment response.

Menarini Silicon Biosystems is working with the FDA to get this application qualified as a response biomarker. This would enable researchers to incorporate CTCs as a response biomarker into clinical trials to expedite the drug development process.

Jennifer Davids, PhD, Director of Field Scientific Support at Menarini Silicon Biosystems Inc, will also be presenting on how the DEPArray technology can overcome the challenges of sample heterogeneity by enabling rare cell sorting with single cell precision.

Presentation Details

Location: Moscone South Convention Center

Monday, March 2 at 1:05 pm

Title:Advancing Liquid Biopsy - presented by Mark Connelly, PhD

Program:Circulating Tumor Cells and Liquid Biopsy

Track:Companion Diagnostics with Liquid Biopsy

Tuesday, March 3 at 11:40 am

Title:  Utilizing the Next Generation Single Cell Sorter, DEPArray - presented by Jennifer Davids, PhD

Program:Immuno-Oncology Biomarkers and Companion Diagnostics

Track:Neoantigen Approaches

“These exciting developments demonstrate our continued commitment in advancing the applications of liquid biopsy,” said Fabio Piazzalunga, President of Menarini Silicon Biosystems. “Our goal at MSB is to contribute to the advancement of precision medicine through innovative rare cell technologies, and we are actively working with our partners in the research community to provide advanced integrated and automated solutions”.

To learn more about the CELLSEARCH and DEPArray Systems, MMTC attendees can visit Menarini Silicon Biosystems at Booth #601.

The 27th International Molecular Medicine Tri-Conference will be held March 1-4, 2020 in San Francisco.

About Menarini Silicon Biosystems

Menarini Silicon Biosystems 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. The company’s CELLSEARCH and DEPArray technologies together provide an end-to-end solution** for enumeration and sorting of rare cells with single-cell precision.

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 17,640 employees in 136 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.