For oncologists and researchers dedicated to unraveling the complexities of solid tumors, circulating tumor cells (CTCs) offer a window into the inner workings of the disease. While identifying and counting these rare cells is informative, gaining deeper insights requires delving into their secrets and thoroughly examining them, revealing the information they hold regarding heterogeneity, treatment response, progression, and, ultimately, each patient's individual path.

The CELLSEARCH® platform, renowned as the gold standard for CTC enumeration, is taking a groundbreaking leap. Expanding beyond the established accuracy and reliability of CTC counts, the company introduced an innovative workflow for rapid User-Defined Assay development coupled with Clinical Service for sample processing. This advancement empowers partnering companies to move beyond the standard EpCAM capture and CTC count, providing them with a versatile set of customizable tools to detect specific markers on CTCs or even other rare cell types present in the blood.

Biomarker Specific Assays

In clinical trials, marker customization can be used in various ways, for instance tracking the effectiveness of immunotherapies. A recent assay developed at Menarini Silicon Biosystems (MSB) targeting Delta-like Ligand 3 (DLL3), a protein frequently overexpressed in aggressive tumors, exemplifies the potential behind this customizable workflow. DLL3 has emerged as a crucial player in Small Cell Lung Cancer treatment. Its limited presence in healthy tissues makes it a beacon for tracking the efficacy of T-Cell Engager therapies against DLL3-expressing tumors. Responding to the growing demand for a minimally invasive readout in DLL3-targeting clinical trials, the R&D group at MSB developed a RUO CTC assay in under four months, specifically for Clinical service. This assay is designed to detect the presence of DLL3 expressed cells among the CTCs found in blood samples submitted to their Clinical team in Huntingdon Valley, PA or in Bologna, Italy. For institutions actively developing treatment strategies based on DLL3 expression, this is a game-changer. By assessing DLL3 levels on CTCs over time, they can gain real-time insights into treatment efficacy of the drugs under development.

The story of DLL3 is just the beginning. With the CellSearch® User-Defined Assay platform, a vast library of potential markers awaits exploration. Each marker holds the promise of unlocking a deeper understanding of a patient's unique cancer and guiding us toward more precise and effective therapies. In the battle against solid tumors, every personalized insight becomes a weapon, and every victory paves the way towards a healthier future for our patients.

The Power of Integration: CTCs + cfDNA/cfRNA

Integrating the analysis of CTCs, cfRNA, and cfDNA into a framework for biomarker discovery and clinical trials represents a powerful strategy to enhance the development and evaluation of new cancer therapies. This approach offers unique advantages in identifying biomarkers, stratifying patients, and assessing treatment efficacy and safety with greater precision and success. In addition, combining CTCs, cfRNA and cfDNA can improve the sensitivity and specificity of cancer detection and characterization in both the early diagnosis and monitoring of minimal residual disease.

Menarini Silicon Biosystems has developed integrated liquid biopsy workflows that are unique in the liquid biopsy space. It is the only CLIA laboratory that offers CTCs and comprehensive genomic profiling in most cancers.

Single-source Solution “The Liquid Biopsy Hub”

From early biomarker discovery through the rigors of clinical trials, MSB's expertise and integrated solutions support pharma companies every step of the way, from developing unique biomarker assays to advanced genetic tests.  Imagine the possibilities of enhancing your research or clinical trials by understanding the disease burden and molecular characteristics of CTCs, cfRNA, and cfDNA from a single blood draw.

With CellSearch® technology, MSB is the undisputed leader in circulating tumor cells, with over 850 publications, 3 FDA-cleared CTC tests, and an extensive RUO and LDT assay menu. CellSearch's reputation in CTC analysis, FDA clearance, and extensive publications offer substantial validation - and value - as your Trusted Partner.

Get in touch with our scientists if you are interested in learning more about Menarini Silicon Biosystems’ User-Defined Assay development workflow or specifically about the DLL3 CTC assay. Learn how we can help you enhance your clinical trials or research through creativity, innovation and experimentation.

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The CELLSEARCH DLL3 Biomarker with CTC Enumeration test is a validated Laboratory Developed Tests offered within a CLIA certified laboratory, and is not cleared or approved by the FDA. The CELLSEARCH User-Defined Assay platform is for research use only. MenariniSearch is a laboratory developed test and is offered in the U.S. only.