Introduction

Despite no radiological evidence of minimal residual disease, up to 25–50% of colorectal cancer (CRC) stage II–III and breast cancer cases experience relapse. Identifying patients at risk of recurrence remains challenging, as approximately 90% of cancer-related deaths are associated with metastasis. The role of circulating tumor cells (CTCs) in extravasation and seeding of distant organs is well established; however, their extracorporeal isolation has not been widely demonstrated in routine practice. Current ex vivo CTC isolation systems often require complex setups and extensive manual handling. In this study, we present an automated device designed to capture and remove CTCs from whole blood using biocompatible cartridges mediated by antibody- and transferrin-conjugated glass bead substrates.

Methods

We developed the OncoMetastat touchscreen-based operational control device, integrating six roller peristaltic pumps and a cartridge containing 680 targeting 2 mm glass beads functionalized with anti-epithelial cell adhesion molecule (EpCAM) antibodies and transferrin protein. The device housing (365 × 200 × 30 mm) contains a bi-spiral channel (95 × 95 × 10 mm) with 680 beads and eight cross-section channels (3.50 × 3.55 mm). A 3D-printed spring-loaded quick-release mechanism ensures secure tube attachment and rapid cartridge exchange.

Flow performance, hemolysis, protein adsorption, and leukocyte interaction were evaluated using blood samples from healthy individuals and cancer patients across multiple cancer types, including breast, CRC, lung, and head and neck cancers. Pyrogenicity was assessed in rabbits according to ISO 10993-11 guidelines.

Results

The device maintained stable blood circulation at 0.5 mL/min for 5–10 mL whole blood samples using a dual snap-fit holder with a 2° angled offset. The peristaltic pump ensured consistent flow without compromising sample integrity. The bead-filled spiral channel effectively retained CTCs, while the integrated design reduced manual handling and improved reproducibility. Low hemolysis (1%), along with reduced serum protein and leukocyte interactions, was observed in both healthy and cancer patient samples. Selective CTC capture was demonstrated in 24 clinical samples across cancer types. All materials passed pyrogenicity testing, with no temperature elevation observed in accordance with guidelines.

Conclusions

The OncoMetastat device successfully depleted CTCs from cancer patient whole blood without adversely affecting blood components. The automated system provides stable blood flow and demonstrates proof of performance for extracorporeal CTC removal, with potential to enhance cancer therapy outcomes.