Menarini Silicon Biosystems new CELLSEARCH® data presented at AACR 2023 annual meeting highlights trailblazing contributions of liquid biopsies for cancer research

Menarini Silicon Biosystems continues to support advances in cancer research by developing new tools and solutions to automate the identification of CELLSEARCH® CTCs (Circulating Tumor Cells) through AI (Artificial Intelligence) and expand the use of liquid biopsies through the analysis of multiple cancer-derived analytes from the same blood draw.

BOLOGNA,Italy and HUNTINGDON VALLEY,Pa.,April 13,2023 -- Menarini Silicon Biosystems (MSB),a pioneer of liquid biopsy and single cell technologies,announced today the data from two posters to be presented at the April 14-19,2023 annual meetingof the American Association for Cancer Research (AACR). Among them,one demonstrated the benefit of an AI algorithm for automated,reliable,and reproducible CELLSEARCH® CTC identification,while the other focused on the additional information available through the parallel immunomagnetic enrichment of tumor derived extracellular vesicles and CTCs from a single blood sample.

According to Ralf Schoenbrunner,Ph.D.,Chief Global R&D Officer at MSB "these two posters underline the multiple opportunities that our technologies can provide for the retrieval of enhanced qualitative and quantitative information in liquid biopsies." Findings were made possible thanks to the use of the company's gold standard CELLSEARCH technology for CTC capture and enumeration,and the use of CellMag for manual immunomagnetic enrichment of CTCs and tumor derived extracellular vesicles (tdEVs).

The posters are scheduled for Monday the 17th of April between 1:30 and 5:00 PM in Session PO.CL01.16 - Liquid Biopsies: Circulating Nucleic Acids and Circulating Tumor Cells 3.

● 3373 /16- Deep learning for circulating tumor cell (CTC) identification with the CELLSEARCH system: achieving top human-level performance

● 3364 / 7- Combined enrichment of plasma EpCAM-positive extracellular vesicles (EVs) and circulating tumor cells (CTCs) from a single tube of cancer patient blood samples,for subsequent molecular analysis

The first poster shows the benefit of an AI-based tool (for research use)that removes human subjectivity and automates the process of CTC identification with CELLSEARCH®. The AI was trainedto identify CTCs using anonymized CELLTRACKS ANALYZER II® images acquired over several years,for a total of 13.469 CTCs and 35.792 non-CTC examplesfrom cancer patients' samples. The performance of the AI-based tool on a separate set of 55 patient samples was compared to that of experienced human reviewers. Theresults overwhelmingly support the use of AI for which performance surpassed 4 out of 5 expert reviewers.

The second poster opens the door to the clinical utility of a simultaneous assessment of multiple analytes from the same blood sample. The parallel enrichment of tumor-derived Extracellular Vesicles (tdEVs) and CTCs from the same blood sample,by means of CellMag EpCAM-based immunomagnetic capture,enabled additional molecular analyses and led to the identification of oncogenic miRNAs (microRNAs) in cancer patients' blood samples resulting in additional insight into the molecular mechanism of cancer.

Additional posters will be presented during the AACR 2023 annual meeting using the CellSearch® and DEPArray™ technologies.

3385 / 28- A pipeline for mRNA analysis on circulating tumor cells (CTCs) collected and stored in preservative tubes

2463 / 3- Protein folding chaperonin as biological indicator for cancer progression and metastasis

1031 / 8 - Specific gene alterations of HER2 positive single circulating tumor cell (CTC) compared to autologous leukocytes in metastatic breast cancer (MBC)

5595 / 19 - Serial monitoring of circulating tumor cells and circulating tumor DNA in metastatic lobular breast cancer identifies intra-tumor heterogeneity and precision and immuno-oncology biomarkers of therapeutic importance

3370/ 13 - Liquid Biopsy approaches to determine tumor cell heterogeneity in advanced prostate cancer

For Fabio Piazzalunga President and CEO of MSB "both our posters and those presented by our partners highlight our never-ending efforts to gather clinically relevant information from blood to develop needed assays for both clinical research as well as improved patient prognosis and care". Indeed,over time,MSB'sliquid biopsy assaysaim to improve cancer care with respect to early detection,identification of residual disease,assessment of treatment response and monitoring of tumor evolution with the ultimate goal to support clinicians in treatment decisions.

More information on the unique and comprehensive MSB offering is available at the company's commercial booth,#100,within the AACR exhibit center. During your visit,you will be able to discover new tests available,and those under development,for user defined biomarker assays for CTCs through the MSB biopharma global laboratory service. Most importantly,two new biomarkers,ARV7 and DLL3,coupled to CTC enumeration,will be available,for research use,in May 2023.

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