Abstract 1994: Performance evaluation of the Smart biopsy™ CTC isolator for circulating tumor cells’ isolation in liquid biopsy

Abstract Introduction: Current cancer diagnostic methods primarily involve tissue biopsies, which are invasive and may not fully reflect tumor heterogeneity. Liquid biopsy, a minimally invasive alternative, has emerged as a promising solution to overcome the limitations of tissue biopsies, offering advantages such as real-time monitoring and reduced patient discomfort for cancer diagnosis. Therefore, the development of reliable, non-invasive diagnostic platforms is crucial for effective cancer management. CytoGen has developed the Smart biopsy™ CTC isolator, a liquid biopsy system designed to isolate circulating tumor cells (CTCs) in blood.. However, since CTCs are present in very low quantities in the blood, it is essential to consider key metrics such as the limit of detection (LoD) and cell recovery rates when developing liquid biopsy-based cancer diagnostic platforms. This study aims to evaluate the performance of the Smart biopsy™ CTC isolator in the isolation of CTCs by assessing LOD and cell recovery rates. Method: To evaluate the performance of CytoGen's Smart Biopsy™ CTC Isolator, recovery rate and limit of detection (LOD) tests were performed using GFP-tagged cancer cell lines. MCF-7, H358, H1975, and RPMI8226 cells (each 200 cells) were spiked into a 5 mL blood sample from a healthy donor to simulate CTCs in patient blood. CTCs were isolated from these spiked samples using CytoGen’s Smart Biopsy™ CTC Isolator. For the LOD test, H358 GFP-tagged cells (spiked at quantities of 20, 10, 5, 3, and 1 cell) were introduced into 5 mL of blood, and the recovery rate was assessed using CytoGen’s Smart Biopsy™ CTC Isolator. Recovery rate and detection precision were analyzed across multiple trials to ensure reproducibility. Results: The recovery rate of Cytogen’s Smart Biopsy TM CTC isolator device demonstrated an average cell recovery rate of over 90% across the four cell lines tested. As a result of LoD test, H358-GFP cells were clearly isolated even in the small number of cells (3 cells in 5mL blood) were spiked into blood. These results suggest that the Cytogen’s Smart Biopsy TM CTC isolator can isolate very small number of CTCs in a blood with high recovery rate, supporting its reliable application in liquid biopsy. Conclusions: Cytogen’s Smart Biopsy TM CTC isolator demonstrated high recovery rates and detection precision, establishing it as a promising tool for CTC isolation in liquid biopsy applications. Its consistent performance in CTC isolation highlights its potential as a non-invasive diagnostic platform, effectively addressing the limitations of traditional tissue biopsies. This study emphasizes the capability of Smart Biopsy TM CTC isolator to facilitate early cancer diagnosis and monitoring through liquid biopsy, contributing to significant advancements in non-invasive cancer diagnostics. Citation Format: Soee Kim, Jihyun Lee, Hoin Kang, Ju Bi Lee, Minseon Hwang, Keoung Sun Son, Jung Won Kim. Performance evaluation of the Smart biopsy™ CTC isolator for circulating tumor cells’ isolation in liquid biopsy [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 1994.