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Circulating Tumor Cells Testing
INTRODUCTION

At the forefront of oncological diagnostics, circulating tumor cells (CTCs) represent a critical component in the battle against cancer. These elusive cells, which break away from primary tumor sites and traverse the bloodstream, hold pivotal information for the early detection, effective treatment monitoring, and accurate prognosis of various cancer types.

Pioneered by Dunwill Medical, the ChimeraX® CTC Detection System introduces a paradigm shift in CTC enrichment methodologies. Utilizing an innovative negative screening approach, this system excels in isolating a comprehensive range of label-free CTC subpopulations. Our technique strategically omits the reliance on surface molecular markers, setting a new standard in precision and efficiency. The process meticulously excludes both white and red blood cells, ensuring an enriched sample of CTCs. Subsequently, advanced immunofluorescence staining techniques are employed to achieve the accurate detection and identification of these critical cells.

This sophisticated approach underscores our commitment to providing cutting-edge solutions in cancer diagnostics, aiding clinicians in making informed decisions and tailoring patient-specific treatment strategies.

Product Introduction
Technical Features
CTC Enrichment Method by Negative Selection
CTC enrichment by negative selection uses a combination of antibodies specific to red and white blood cells to crosslink them, and utilizes a density gradient centrifugation method to remove most of the red and white blood cells in the blood sample, achieving maximum CTC harvest. Immunofluorescence staining uses multiple specific fluorescent-labeled antibodies to recognize antigen markers of CTCs in the blood, and combines them with white blood cell markers to distinguish CTC cells in the sample. We provide a variety of CTC detection reagents. In addition to epithelial CTC markers, the R&D team has also developed detection reagents that can specifically recognize different types of CTC, meeting various clinical research needs. In addition, comprehensive performance validation is conducted to ensure the stability of the CTC detection process and the reliability of the results.
ChimeraX® Performance Analysis
In terms of performance analysis, in the experiment involving the incorporation of tumor cell lines into blood, Dunwill Medical ChimeraX® CTC detection can achieve a CTC cell recovery rate of 80% -90%, with a linear correlation coefficient (R2) greater than 0.99 and a minimum detection limit of 2 CTCs per 5mL. In the specificity test, the detection rate of CTCs in 30 healthy individuals was 0%. In the anti-interference test, high concentrations of triglycerides, bilirubin, or hemoglobin were mixed into the blood. Compared with normal blood samples, the CTC test result showed a coefficient of variation (CV) of less than 10%, indicating good anti-interference performance.
Prospect of Application
➀ CTC identification and counting: immunofluorescence staining + high-content imaging analysis
Image analysis based on artificial intelligence can accurately identify CTC in the blood. This assists in more accurate tumor staging, predicting the risk of tumor recurrence and metastasis, and helps in developing advanced treatment strategies. It can reflect the genetic background of tumors, achieve dynamic monitoring, and aid in formulating personalized treatment plans. This approach represents one of the potential non-invasive solutions for cancer management in clinical practice.
➁ CTC Morphological Analysis
Establishing a CTC morphological analysis system enable the in-depth exploration of the clinical value of different morphological features of CTCs. This provides crucial insights for studying the biological characteristics of tumor cells, revealing the mechanisms of tumor cell metastasis, and offers powerful tools and information for the discovery of new targets and the development of personalized treatment strategies.
➂ CTC Single-cell Sequencing Analysis: CTC Single-cell Fully Automatic extraction + Whole Genome Amplification and Sequencing Library Preparation
By integrating two major platforms, CTC detection and single-cell sequencing, along with a standardized workflow, we ensure the quality of CTC single-cell sequencing and the reliability of whole genome analysis results. This approach provides insights into the heterogeneity of tumors, genetic variations, clonal dynamics of tumor evolution, and the expression of immune-related genes and immune cell infiltration. These insights are invaluable for understanding the mechanisms of tumor occurrence, development, metastasis, and diffusion, predicting disease progression and outcome, and achieving more accurate disease classification. Additionally, it sheds light on the mechanisms of tumor immune escape and drug resistance, identifies potential drug targets, and further optimizes individualized treatment plans. Furthermore, we offer bioinformatics analysis services to meet clinical and research needs.
➃ CTC Case Study
Patient Information 1
Gender: Male; Age: 56

In July 2018, the patient underwent partial hepatectomy, cholecystectomy, common bile duct incision and thrombectomy, as well as T-tube drainage at Zhongshan Hospital Affiliated with Fudan University.

Pathology: HCC grade II G1S4 MVI: M1

Following the surgery, TACE treatment was administered over a month later. CTC was detected 3 months post-surgery, and multiple CTC tests were conducted within one year on after surgery. T-tube chemotherapy was performed in November 2018, December 2018, and February 2019, respectively. In July 2019, an MRI examination revealed left lateral lobe recurrence (17mm).

In July 2019, the patient was readmitted for surgical treatment.

Conclusion: The dynamic monitoring of CTC suggests the possibility of tumor metastasis, and subsequent imaging examination results confirm this prediction. CTC detection precedes imaging, indicating disease progression.

Regular postoperative peripheral blood CTC testing can aid in evaluating treatment response and efficacy, dynamically monitoring disease progression, and indicating recurrence and metastasis at an early stage.
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