This new CELLSEARCH Circulating Tumor Cell (CTC) test is now available as a Research Use Only (RUO) laboratory service in North America and Europe. Currently dedicated to basic and pharmaceutical research, it is the latest example of how Menarini Silicon Biosystems continues its development of personalized assays, from liquid biopsy, that allow biopharmaceutical companies to support the evaluation of the response to treatment of new drugs. targeting specific biomarkers in clinical trials.

BOLOGNA, Italy and HUNTINGDON VALLEY, Pa., July 13, 2023 /PRNewswire/ -- Menarini Silicon Biosystems (MSB), a pioneer in liquid biopsy and single cell technologies, today announced the availability of its new CELLSEARCH CTC laboratory service to detect the expression of the Delta-Like Ligand 3 (DLL3) protein in circulating tumor cells in the bloodstream. This biomarker is manifested mainly in difficult-to-treat cancers. MSB's new laboratory service opens the door to the development of other minimally invasive tests that take advantage of the prognostic and predictive value of biomarkers in medical settings with extensive unmet needs.

According to Ralf Schoenbrunner, Managing Director of R&D at Menarini Silicon Biosystems, "We have the ability to develop tests of this type very quickly. This is important because new biomarkers are helping clinical researchers determine response to treatment in cancer trials." , as well as guide clinicians in their selection of therapies to improve outcomes in cancer patients. Rapid availability of new biomarker assays is essential to making this progress possible."

Lung cancer is the second most common cancer worldwide, with more than 2.2 million cases in 2020. Small cell lung cancer (SCLC) accounts for around 15%[1] of these cancers and is more aggressive than lung cancer. non-small cell (NSCLC), with the highest prevalence and often diagnosed in the advanced phase of the disease. DLL3 is a Notch receptor inhibitory ligand whose overexpression on the surface of neuroendocrine neoplasms (NEN) is associated with the formation of high-grade neuroendocrine tumor types such as SCPC. The DLL3 biomarker is of great interest because it is highly expressed in the tumor tissue of patients with SCLC and other NEN, but minimally in normal tissue. For this reason, scientists around the world are increasingly investigating the DLL3 proteins, as they could represent targets for clinical action.

CTCs in the bloodstream represent a pre-metastatic population implicated in tumor spread. The fact that DLL3 positivity may be associated with more aggressive disease strongly supports the clinical relevance of enumeration and characterization of CTCs expressing this protein.

In addition, the new CELLSEARCH CTC test that detects this biomarker has the great advantage of being minimally invasive, standardized, and allowing real-time dynamic quantification of CTCs. It is supported by the CELLSEARCH CTC platform, the first and only system clinically validated and cleared by the FDA for the identification, isolation, and enumeration of CTCs in patients with metastatic breast cancer, castration-resistant prostate, or colorectal cancer. It is the first time that the CELLSEARCH platform has been made available to biopharmaceutical companies, focused on the development of treatments against lung cancer and other NEN.

According to Fabio Piazzalunga, President and CEO of Menarini Silicon Biosystems (MSB), "Our unique CELLSEARCH technology allows us to use any type of tumor protein marker to characterize CTCs. This expands Menarini Silicon Biosystems' portfolio of commercially available assays and demonstrates the ability of this technology to accommodate other goals that pharmaceutical companies may be interested in."

The phenotypic characterization of CTCs has the potential not only to support biopharmaceutical companies in their clinical development programs, but in the future it will also enable decisions on personalized therapeutic strategies in an increasingly wide range of tumor types. This will help avoid delays in needed therapies, minimize patient exposure to unnecessary medical strategies, and reduce the high costs of inappropriate care.

About Menarini Silicon Biosystems (MSB)

MSB offers unique rare cell technologies and solutions that allow clinical researchers to access unparalleled resolution in the study of cells and their molecular characterization.

Menarini Silicon Biosystems, headquartered in Bologna, Italy, and Huntingdon Valley, Pennsylvania, United States, is a wholly owned subsidiary of the Menarini Group, a multinational pharmaceutical, biotechnology and diagnostics company headquartered in Florence, Italy with 17,000 employees. in 140 countries.

[1] Owen DH, Giffin MJ, Bailis JM, Smit MD, Carbone DP, He K. DLL3: an emerging target in small cell lung cancer. J Hematol Oncol. 18 de junio de 2019;12(1):61.

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