Clinical results of microfluidic antibody-independent peripheral blood circulating tumor cell capture for the diagnosis of lung cancer

Objectives: The ability to capture and characterize peripheral blood circulating tumor cells has the potential for the development of a blood test for cancer. The aim of this study was to evaluate the diagnostic performance of microfluidic technology as a proof-of-concept study. Methods: Blood from patients undergoing surgery for known or suspected lung cancer was obtained and processed using a microfluidic biochip. Diagnostic performance was evaluated against the reference of cancer identified within surgically obtained formalin-fixed paraffin embedded specimens reported by a principal pathologist. Agreement was assessed in a sample reported by a second independent pathologist. Sensitivity- and specificity-weighted analyses were undertaken. Results: From March 2011 to October 2012, 46 patients at our institution donated blood for research. Cancer was the underlying diagnosis in 43 (94%); 34 (79%) of the patients had primary lung cancer. The proportion of patients with cancer in which atypical cells suspicious for cancer were identified on hematoxylin and eosin staining was 16/43 (37%) by the principal pathologist and 10/17 (59%) by the second pathologist. On sensitivity-weighted analysis, the sensitivity of the biochip was 54% (95% confidence interval [CI], 37-72) and the specificity was 33% (95% CI, 2-91). On specificity-weighted analysis, the sensitivity was 43% (95% CI, 21-71) and the specificity was 100% (95% CI, 5-100). Conclusions: This work highlights the potential of microfluidic technology to develop a blood test for the diagnosis of cancer using peripheral blood; conventional clinical criteria can be used as a proof-of-concept of what may be possible with today's technology.