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Detection of rare tumor cells circulating in the blood ( CTC s) presents technical challenges. CellSearch, the only approved system for clinical use, fails to capture epithelial cell adhesion molecule‐negative  CTC s such as malignant pleural mesothelioma ( MPM ). We have developed a novel microfluidic device ( CTC ‐chip) in which any Ab to capture  CTC s is conjugated. The  CTC ‐chip was coated with an Ab against podoplanin that is abundantly expressed on  MPM .  Circulating tumor cell ‐detection performance was evaluated in experimental models in which  MPM  cells were spiked in blood sampled from a healthy volunteer and in clinical samples drawn from  MPM  patients. The  CTC ‐chip showed superior  CTC ‐detection performance over CellSearch in experimental models (sensitivity, 63.3%‐64.5% vs 0%‐1.1%;  P  <   .001) and in clinical samples ( CTC ‐positivity, 68.8% vs 6.3%;  P  <   .001). A receiver operating characteristic ( ROC ) analysis showed that the  CTC  test provided a significant diagnostic performance in discrimination of unresectable disease from resectable disease (area under the  ROC  curve, 0.851;  P  =   .003). The higher  CTC  count (≥2 cells/mL) was significantly associated with a poor prognosis ( P  =   .030). The novel  CTC ‐chip enabled sensitive detection of  CTC s, which provided significant diagnostic and prognostic information in  MPM .

Detection of circulating tumor cells with a novel microfluidic system in malignant pleural mesothelioma