Liquid biopsy has emerged as a revolutionary tool for clinical trials, offering cellular and cell-free methods that provide valuable insights into disease progression and treatment response. Circulating tumor cells (CTCs) and cell-free DNA and cell-free RNA (cfDNA/cfRNA) allow for detecting cancer-specific genetic alterations and monitoring tumor heterogeneity over time and upon treatment. Despite their strengths, the current challenge lies in integrating these diverse cellular and non-cellular methods into a cohesive workflow for truly comprehensive patient monitoring.
The power of integration
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 dynamism. In addition, combining CTCs cfRNA and cfDNA can improve the sensitivity and specificity of cancer detection, especially in the early diagnosis and monitoring of minimal residual disease.
Menarini Silicon Biosystems (MSB) has developed a unique integrated workflow that distinguishes them from the rest of the liquid biopsy providers. Their liquid biopsy workflow solutions enable maximum insights from a single blood draw. The workflow delivers consistent cellular phenotypic and molecular data from CTCs, cfRNA, and cfDNA. MSB’s combination of established leadership in CTC analysis (CellSearch®) since 2004, cutting-edge combined cfRNA/cfDNA profiling (MenariniSearch®) introduced in 2023, and its proprietary CellSave® and CellRescue® blood collection tubes make its biopharma and clinical service a genuine “Liquid Biopsy Hub.”
Agility & resource optimization
MSB`s assay development and clinical services are a perfect solution for small to mid-sized companies, which often benefit from outsourcing specialized liquid biopsy work. MSB offers a cost-effective and time-saving alternative to developing in-house capabilities, allowing biopharma companies to focus on their core drug development work.
“Sometimes, we see mutations or aberrations in DNA, but they might not be expressed in the protein or have a phenotype. By looking at RNA, we can understand how DNA is transcribed and that it is one step closer to expression. We can also understand the aberrant or mutated DNA phenotype by looking at RNA. That’s one of the advantages of analyzing RNA versus just DNA,” explains Frank Kuhr, Vice President of Medical Affairs at MSB.
Below are some ways you could benefit from Menarini Silicon Biosystem’s Liquid Biopsy Hub –
Enhancing biomarker discovery
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Comprehensive genetic and molecular profiling
CTCs, cfRNA, and cfDNA provide complementary information about the tumor’s genetic makeup, gene expression profiles, and epigenetic modifications. By analyzing different analytes together, researchers can uncover a broader spectrum of biomarkers, including mutations, gene expression patterns, and non-coding RNA species that could serve as targets for new drugs or indicators of disease prognosis.
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Real-time monitoring of tumor evolution
The tumor microenvironment and genetic composition can evolve under therapeutic pressure. Continuous monitoring of the liquid biopsies allows for identifying dynamic changes in biomarker profiles over time, revealing mechanisms of resistance or sensitivity to treatments that can be crucial for developing next-generation therapies.
Advancing clinical trials
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Precise patient stratification
Integrating CTC, cfRNA, and cfDNA analyses enables the identification of specific biomarkers that can precisely stratify patients into subgroups more likely to benefit from the therapy under investigation. This precision in patient selection can increase the likelihood of clinical trial success by ensuring the inclusion of participants whose tumors harbor genetic or molecular features targeted by the study drug.
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Early response indicators and safety monitoring
Changes in the quantity of CTCs or the genetic and expression profiles derived from cfDNA and cfRNA can be early indicators of treatment response or toxicity. This real-time monitoring allows quicker adjustments in trial protocols, such as dose modifications or early termination of trials for ineffective or harmful drugs.
Accelerating drug development through biomarker-driven trials
Integrating liquid biopsy data from different analytes can facilitate the design of biomarker-driven clinical trials, where therapies are tested more specifically based on specific biomarkers. This approach can speed up the development process by focusing on candidates with a higher probability of success. It can lead to the approval of therapies with clear, biomarker-defined indications. “MSB uses AI to confidently report actionable genomic alterations and match those up with clinical trials or the drugs indicated for those specific mutations,” explains Kuhr.
Sample preservation expertise
Once drawn, blood samples start to degrade immediately. Cells die, DNA and RNA fragments change, and protein expression can change. This natural degradation compromises the accuracy and reliability of any downstream analysis, including liquid biopsies.
MSB’s proprietary tubes contain specialized preservatives designed to combat these degradation processes. Preserve the morphology and cell surface antigen expression for circulating tumor cell analysis or downstream molecular characterization. Stabilize cells for up to 96 hours with CellSave™ tubes or up to 120 hours with CellRescue® tubes. CellSave Preservative tubes are registered IVD products.
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 many LDTs. CellSearch’s reputation in CTC analysis, FDA clearance, and extensive publications offer substantial validation as your Trusted Partner.
Download to understand various workflow options under MSB’s Liquid Biopsy Hub!
