Menarini Silicon Biosystems announces the launch of its new CELLSEARCH® CTC test with the DLL3 biomarker for small cell lung cancer

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This new CELLSEARCH Circulating Tumor Cell (CTC) test is now available as a Research Use Only (RUO) lab service in North America and Europe. It is currently intended for basic and pharmaceutical research and it is the latest example of how Menarini Silicon Biosystems continues its development of customized liquid biopsy-based assays enabling Biopharma companies to support the assessment of treatment response to new drug candidates 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, announced today the availability of its new CELLSEARCH CTC lab service to detect expression of the Delta-Like Ligand 3 (DLL3) protein in tumor cells circulating in the bloodstream. This biomarker is mainly expressed in difficult-to-treat cancers. The new MSB lab service opens the door to the development of further minimally invasive tests that leverage the prognostic and predictive value of biomarkers in medical settings with high unmet needs.

According to Ralf Schoenbrunner, Chief Global R&D Officer of Menarini Silicon Biosystems, "We have the capability to develop such tests very quickly. This is important because new biomarkers are helping clinical researchers to determine treatment response in oncology trials, as well as guide physicians in their selection of therapies to improve outcomes in cancer patients. Making new biomarker assays quickly available is key to enable this progress."

Lung cancer is the second most common cancer worldwide with over 2.2 million cases in 2020. Small cell lung cancer (SCLC) represents about 15%^[1] of these cancers and is more aggressive than the more prevalent Non-Small Cell Lung Cancer (NSCLC) and often diagnosed in the late stage of the disease. DLL3 is an inhibitory ligand of the Notch receptor whose overexpression on the surface of neuroendocrine neoplasms (NENs) is associated with the formation of high-grade neuroendocrine tumor types such as SCLC. The DLL3 biomarker is of great interest because it is highly expressed in the tumor tissue of patients with SCLC and other NENs but minimally in normal tissue. For this reason, scientists worldwide are increasingly investigating DLL3 proteins as they could represent clinically actionable targets.

CTCs in the bloodstream represent a premetastatic population involved in tumor dissemination. The fact that DLL3 positivity may be associated with more aggressive disease, strongly supports the clinical relevance of enumeration and characterization of CTCs that express this protein.

In addition, the new CELLSEARCH CTC test that detects this biomarker has the great advantage of being minimally invasive, standardized and allows for the dynamic real-time quantification of CTCs. It is based on the CELLSEARCH CTC platform, first and only clinically validated, FDA-cleared system for identification, isolation, and enumeration of CTCs in patients with metastatic breast, castration-resistant prostate or colorectal cancer. This is the first time that the CELLSEARCH platform is being made available for biopharma companies, who are focusing on developing treatments for lung cancer and other NENs.

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

CTC phenotypic characterization has the potential to not only support biopharma companies in their clinical development programs but in the future will also allow for decision making on personalized therapeutic strategies in an increasingly larger range of tumor types. This will help to 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 provide clinical researchers with access to unparalleled resolution in the study of cells and their molecular characterization.

Menarini Silicon Biosystems, 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.

^[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. 2019 Jun 18;12(1):61.

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