PR93687

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

BOLOGNA, Italy and HUNTINGDON VALLEY, Pa., Dec. 14, 2021 /PRNewswire=KYODO JBN/ --

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 analysed 185 blood samples from precursor patients (75 MGUS and 110

SMM) from the Dana-Farber Cancer Institute observational PCROWD study. Blood

was collected in CellRescu(TM) Preservative Tubes and processed on the

CellTracks Autoprep(TM) system using the CELLSEARCH(R) CMMC assay kit.

Additional molecular analyses were carried out on 13 patients, where minipools

of CMMCs sorted by DEPArray(TM) NxT underwent whole genome amplification using

Ampli1(TM) WGA.

Results showed that CMMCs were detected in 27% of MGUS patients and in 57% SMM

patients. Enumeration of CMMCs illustrated a correlation with the clinical

measure of disease including the International Myeloma Working Group 2/20/20

risk stratification model. CMMCs can capture 100% of clinically annotated Bone

Marrow FISH copy number variant [CNV] events. Furthermore, CMMC samples

identified additional CNVs that were not observed by FISH.

This study provides a foundation for non-invasive detection, enumeration, and

genomic interrogation of rare CMMCs from the peripheral blood of MGUS/SMM,

illustrating the clinical potential of using liquid biopsies for monitoring the

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(R) CMMC Assay

The CELLSEARCH(R) 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(R) circulating cell capture, enrichment and enumeration platform.

The US Lab is CLIA Certified and ISO 15189 Accredited for CELLSEARCH(R). 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 [ www.siliconbiosystems.com ], 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.

About Dana-Farber Cancer Institute

Dana-Farber Cancer Institute [ http://www.dana-farber.org/ ]is 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 treatments in cancer for adults through Dana-Farber

Brigham Cancer Center [ https://www.youhaveus.org/ ]  and for children through

Dana-Farber/Boston Children's Cancer and Blood Disorders Center [

http://www.danafarberbostonchildrens.org/ ]. 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 a global 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, offering more

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

Logo - https://mma.prnewswire.com/media/1362208/Menarini_Logo.jpg  

Source:  Menarini Silicon Biosystems