BOLOGNA, Italy and HUNTINGDON VALLEY, Pa., 7 June, 2021 – Menarini Silicon Biosystems, a pioneer of liquid biopsy and single cell technologies, announced today the results of a pilot study on a new application of its CELLSEARCH Circulating Endothelial Cells (CECs) assay* to analyze vascular dysfunction in patients with systemic sclerosis (SSc). This study was presented during the 2021 EULAR (European League Against Rheumatism) virtual congress poster session available to registered delegates from the 2^nd of June to the 5^th of July. The assay is a standardized, semi-automated, rapid test to detect and count CECs. Used for the first time in this autoimmune disorder, CEC enumeration may have a transformative effect in understanding disease progression in SSc moving forward.

Endothelial cells are present in the inner lining of arteries, veins and capillaries where they are responsible for blood fluidity and regulation of inflammatory reactions. The release of these cells into the blood stream and their enumeration represent a potential biomarker for vascular dysfunction and damage.

According to Francesca Pignataro, MD, Department of Rheumatology (Director Professor Roberto Caporali) of the ASST Gaetano Pini-CTO, Milan, Italy “SSc represents a major challenge for us and indeed the related vascular injury and resulting fibrosis lead to serious complications. In our pilot study to assess the clinical implications of CEC count leveraging the CELLSEARCH System, we were impressed not only by the ten-fold increase in the number of these cells in SSc patients compared to healthy volunteers, but also the significant correlation of CEC number with digital ulcers and active disease.”

This finding opens the door to a whole new approach to managing the vascular involvement associated with SSc, which plays a key role in disease pathogenesis and clinical manifestation. A biomarker to predict clinical outcomes is strongly needed.

Nicoletta Del Papa, MD, Head of the Scleroderma Clinic, Department of Rheumatology of the ASST Gaetano Pini-CTO Milan, Italy added that “Digital ulcers and pulmonary hypertension (PAH) are representative of the vascular damage in SSc. Furthermore, they are relevant clinical manifestations which greatly affect patients’ prognosis and quality of life. There is a clinical need for biomarkers to predict disease occurrence or monitor for signs of progression following diagnosis. The CELLSEARCH, a robust and standardized System, may provide reliable and reproducible CEC count which, in the future, could help to identify patients at greatest risk.”

“We are excited to be able to expand our technology beyond onco-hematology and oncology,” said Fabio Piazzalunga, President and CEO of Menarini Silicon Biosystems. “The robust results obtained with the CELLSEARCH CEC test represent a strong incentive for exploring the use of our technology in other autoimmune diseases where effective and reliable CEC counts can be so useful.”

Blood collected with the CellSave Preservative Tubes can be stored at room temperature for 72 hours. Samples can be shipped to one of the Menarini Silicon Biosystems central labs for rapid turnaround of the information needed.

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^® circulating rare 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.