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Circulating tumor cells ( CTC s) are a tumor‐derived material utilized for liquid‐based biopsy; however, capturing rare  CTC s for further molecular analysis remains technically challenging, especially in non‐small‐cell lung cancer. Here, we report the results of a clinical evaluation of On‐chip Sort, a disposable microfluidic chip‐based cell sorter, for capture and molecular analysis of  CTC s from patients with lung adenocarcinoma. Peripheral blood was collected from 30 metastatic lung adenocarcinoma patients to enumerate  CTC s using both On‐chip Sort and CellSearch in a blind manner. Captured cells by On‐chip Sort were subjected to further molecular analysis. Peripheral blood samples were also used for detection of   EGFR   mutations in plasma using droplet digital  PCR . Significantly more  CTC s were detected by On‐chip Sort (22/30; median 5; range, 0–18 cells/5  mL  blood) than by CellSearch (9/30; median, 0; range, 0–12 cells/7.5 mL) ( P  < 0.01). Thirteen of 30 patients who had a negative  CTC  count by CellSearch had a positive  CTC  count by On‐chip Sort.   EGFR   mutations in  CTC s captured by On‐chip Sort were observed in 40.0% (8/20) of patients with   EGFR  ‐mutated primary tumor.   EGFR   mutations were often observed in 53.3% (8/15) of patients detected in plasma  DNA . Expressions of  EGFR  and vimentin protein on  CTC s were also successfully assessed using On‐chip Sort. These results suggest that On‐chip Sort is an efficient method to detect and capture rare  CTC s from patients with lung adenocarcinoma that are undetectable with CellSearch. Mutation detection using isolated  CTC s remains to be further tackled ( UMIN 000012488).

Isolation and molecular analysis of circulating tumor cells from lung cancer patients using a microfluidic chip type cell sorter