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

As the market leader in cell-based liquid biopsies,Menarini Silicon Biosystems is offering community hematology-oncologists an opportunity to have patient blood samples sent to a US centralized laboratory where its CELLSEARCH®technology can enumerate Circulating Multiple Myeloma Cells (CMMCs)for non-invasive monitoring of disease

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

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 Testand 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,andHuntingdon Valley,PA.,U.S.,is a wholly owned subsidiary of the Menarini Group,a multinational pharmaceutical,biotechnology and diagnostics company headquartered inFlorence,with more than 17,000 employees in 140 countries.

Linda PAVY – lipavy@pavyconsulting.com