Menarini Silicon Biosystems Announces Study Results Presented at American Society of Hematology (ASH) Annual Meeting Highlighting CELLSEARCH® CMMC assay, a Non-Invasive Liquid Biopsy for the Quantification and Molecular Characterization of Circulating Mul

BOLOGNA,Italy andHUNTINGDON VALLEY,Pa.,Dec. 15,2021 -- Menarini Silicon Biosystems (MSB),a pioneer of liquid biopsy and single cell technologies today announced that Dana-Farber Cancer Institute and the Multiple Myeloma Research Foundation presented data in an oral presentation at the 2021 ASH Annual Meeting that showcases the importance of Non-Invasive Liquid Biopsy to Quantify and Molecularly Characterize Circulating Multiple Myeloma Cells (CMMC).

The study analysed185blood samples fromprecursor patients (75MGUS and110SMM) from the Dana-Farber Cancer Institute observational PCROWD study. Blood was collected inCellRescue™ Preservative Tubes and processed on the CellTracks Autoprep™system using the CELLSEARCH® CMMC assay kit.Additional molecular analyses were carried out on 13 patients,whereminipoolsof CMMCs sorted byDEPArray™ NxT underwent whole genome amplification using Ampli1™ WGA.

Results showed that CMMCs were detected in 27% of MGUS patients andin 57% SMM patients.EnumerationofCMMCsillustrated a correlation with the clinical measure of disease including the International Myeloma Working Group 2/20/20 risk stratificationmodel. CMMCscan capture 100% of clinically annotated Bone Marrow FISH copy number variant [CNV] events. Furthermore,CMMC samples identified additional CNVs that were not observed byFISH.

Thisstudy provides a foundation for non-invasive detection,enumeration,and genomic interrogation of rare CMMCs fromthe peripheral blood of MGUS/SMM,illustrating the clinical potential of using liquid biopsies formonitoringthe disease in the precursor setting of MM.

The oral presentation took place at the ASH 2021 Annual Meeting in Atlanta on Saturday December 11th at 10:45am. Further details about the presentation can be found through the link below:

https://ash.confex.com/ash/2021/webprogram/Paper150622.html

"The future use of circulating tumor cells as diagnostic and prognostic biomarkers in myeloma disease progression will likely be paradigm shifting and can improve care for all our patients" said Irene Ghobrial MD,Professor of Medicine at Harvard Medical School,Dana-Faber Cancer Institute.

"The data in this study demonstrate the future viability of liquid biopsy to monitor multiple myeloma in the precursor setting," said Hearn Jay Cho MD,PhD,Chief Medical Officer of the MMRF. "As a patient focused organization,the MMRF is committed to advancing innovative research to improve clinical care and disease management. These findings are an important step forward in liquid biopsy for advanced molecular diagnostics for clinicians and patients alike."

"Research of this nature demonstrates our ongoing commitment to excellence in providing scientific evidence to address unmet clinical needs and rapidly translate this into future clinical care for improved patient management." said Fabio Piazzalunga,President and CEO of Menarini Silicon Biosystems,"We appreciate the opportunity to work with the fabulous research teams at both Dana-Farber Cancer Institute and the Multiple Myeloma Research Foundation as they continue to deliver high quality data highlighting the potential value that a non-invasive liquid biopsy test could bring to improve patient management in Multiple Myeloma."

About the CELLSEARCH® CMMC Assay

The CELLSEARCH® Circulating Multiple Myeloma Cells (CMMC) assay is the first test of its kind to enumerate circulating multiple myeloma cells from peripheral blood.

The Assay is for research use only and not for use in diagnostic procedures.

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.

About Dana-Farber Cancer Institute

Dana-Farber Cancer Instituteis one of the world's leading centers of cancer research and treatment. Dana-Farber's mission is to reduce the burden of cancer through scientific inquiry,clinical care,education,community engagement,and advocacy. Dana-Farber is a federally designated Comprehensive Cancer Center and a teaching affiliate of Harvard Medical School.

We provide the latest treatmentsin cancer for adults throughDana-Farber Brigham Cancer Center and for children throughDana-Farber/Boston Children's Cancer and Blood Disorders Center. Dana-Farber is the only hospital nationwide with a top 10 U.S. News & World Report Best Cancer Hospital ranking in both adult and pediatric care.

As aglobal leader in oncology,Dana-Farber is dedicated to a unique and equal balance between cancer research and care,translating the results of discovery into new treatments for patients locally and around the world,offeringmore than 1,100 clinical trials.

About the Multiple Myeloma Research Foundation (MMRF)

A pioneer in precision medicine,the Multiple Myeloma Research Foundation (MMRF) seeks to find a cure for all multiple myeloma patients by relentlessly pursuing innovations that accelerate the development of precision treatments for cancer. Founded in 1998 by Kathy Giusti,a multiple myeloma patient,and her twin sister Karen Andrews as a 501(c)(3) nonprofit organization,the MMRF has created the business model around cancer—from data to analytics to the clinic. The MMRF identifies barriers and then finds the solutions to overcome them,bringing in the best partners and aligning incentives in the industry to drive better outcomes for patients. Since its inception,the organization has collected thousands of samples and tissues,opened nearly 100 trials,helped bring 14 FDA-approved therapies to market,and built CoMMpass,the single largest genomic dataset for any cancer. Today,the MMRF is building on its legacy in genomics and is expanding into immunotherapy,as the combination of these two fields will be critical to making precision medicine possible for all patients. The MMRF has raised more than $500 million and directs nearly 90% of the total funds to research and related programs. To learn more,visit www.themmrf.org.

Linda PAVY – lipavy@pavyconsulting.com