PR93728

BOLOGNA, Italy and HUNTINGDON VALLEY, Pa., Dec. 16, 2021 /PRNewswire=KYODO JBN/ --

Tissue biopsies with tumor cell contents that are too low for conventional

testing methods can now be rescued due to the ability of MSB's DEPArray

technology to successfully recover low numbers of tumor cells from these

difficult samples.  The new FFPE Rescue Application will provide pathology labs

with a validated workflow to identify potentially targetable mutations in more

FFPE biopsy samples.

Menarini Silicon Biosystems (MSB), a pioneer of single cell technologies,

announced today its new FFPE Rescue Application, to enable molecular testing on

formalin-fixed, paraffin-embedded (FFPE) samples with low tumor cell contents.  

Thanks to the sorting capabilities of the recently launched DEPArray PLUS

instrument, it is possible to isolate a sufficient number of tumor cells to

generate relevant molecular data, even from FFPE tissues that were previously

discarded from conventional Next Generation Sequencing (NGS) processing. Thus,

the DEPArray PLUS workflow can reduce the failure rates of FFPE molecular

analyses and provide clinical researchers with valuable information about

actionable mutations, potentially improving clinical trial recruitment and

allowing more patients to access new targeted therapies.

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

Formalin fixation and paraffin embedding remains the gold standard preservation

method of human tissue for molecular diagnostics. NGS of FFPE tissue is

becoming increasingly important to identify targetable mutations and has

greatly enhanced the ability of physicians to optimize treatment strategies.

However, not all FFPE samples are suitable for molecular analyses. The failure

rate for molecular testing of FFPE tissues ranges between 5 and 15%, with the

primary driver being low tumor content. The precise digital sorting capability

of DEPArray PLUS allows for the isolation of small pools of only a few hundred

tumor cells that are then suitable for NGS library preparation and sequencing.

According to Dr Javier Hernández Losa, Director of the Molecular Biology

Laboratory within the Pathology Department at the Vall d´Hebron University

Hospital in Barcelona, Spain "the DEPArray platform allows us to conduct

unambiguous genetic analyses on FFPE samples that failed the standard NGS

procedure and identify potentially targetable mutations". MSB and the Vall

d'Hebron University Hospital have recently engaged in a research collaboration

to expand the types of complex samples that can be analyzed by DEPArray, such

as cytologic samples. The Vall d'Hebron University Hospital Pathology lab

provides molecular testing for many hospitals throughout Catalonia. It aims to

establish a NGS testing service across the entire region to provide the

information that will help physicians improve their decision-making and patient

care.

Prof Lorenzo Leoncini, MD, Head of the Department of Medical Biotechnology and

Director of the Pathological Anatomy Division at the University of Siena, Italy

adds that: "the DEPArray technology helped to rescue tissue samples with less

than a 5% tumor cell content to generate robust data on cancer mutations. We

are now planning to use this technology in different new research projects. For

example, we will use DEPArray to study tumor cells in classical Hodgkin

Lymphoma tissue biopsies, a setting in which isolation of these rare cells is

extremely challenging, as they are present in a very low percentage compared to

normal cells".

"We are excited to be able to deliver such a unique technology for the analysis

of FFPE biopsies with low tumor cellularity," said Fabio Piazzalunga, President

and CEO of MSB. "Our DEPArray platform could help pathology labs reduce the

significant burden, caused by FFPE biopsies that are rejected from molecular

analysis and support pharma companies involved in clinical trials to expedite

recruitment".

About Menarini Silicon Biosystems (MSB)

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 proprietary

DEPArray(TM) technology allows for the gentle sorting of single rare cells from

heterogeneous samples including low cellularity FFPE tissues.

Menarini Silicon Biosystems (http://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.

--For research use only. Not for use in diagnostic procedures.

SOURCE: Menarini Silicon Biosystems