miR-Test: A Blood Test for Lung Cancer Early Detection

• Published in: JNCI : Journal of the National Cancer Institute Vol. 107; no. 6; p. djv063
• Main Authors: Montani, Francesca, Marzi, Matteo Jacopo, Dezi, Fabio, Dama, Elisa, Carletti, Rose Mary, Bonizzi, Giuseppina, Bertolotti, Raffaella, Bellomi, Massimo, Rampinelli, Cristiano, Maisonneuve, Patrick, Spaggiari, Lorenzo, Veronesi, Giulia, Nicassio, Francesco, Di Fiore, Pier Paolo, Bianchi, Fabrizio
• Format: Journal Article
• Language: English
• Published: United States Oxford Publishing Limited (England) 01.06.2015
• Subjects: Adult; Aged; Area Under Curve; Biomarkers, Tumor - blood; Early Detection of Cancer - methods; Female; Humans; Lung cancer; Lung Neoplasms - blood; Lung Neoplasms - diagnosis; Lung Neoplasms - diagnostic imaging; Lung Neoplasms - etiology; Lung Neoplasms - genetics; Male; Medical screening; MicroRNAs - blood; Middle Aged; Mortality; Population Surveillance; Predictive Value of Tests; Ribonucleic acid; RNA; Sensitivity and Specificity; Smoking - adverse effects; Tomography; Tomography, X-Ray Computed
• ISSN: 0027-8874; 1460-2105; 1460-2105
• DOI: 10.1093/jnci/djv063

Lung cancer is the leading cause of cancer death worldwide. Low-dose computed tomography screening (LDCT) was recently shown to anticipate the time of diagnosis, thus reducing lung cancer mortality. However, concerns persist about the feasibility and costs of large-scale LDCT programs. Such concerns may be addressed by clearly defining the target "high-risk" population that needs to be screened by LDCT. We recently identified a serum microRNA signature (the miR-Test) that could identify the optimal target population. Here, we performed a large-scale validation study of the miR-Test in high-risk individuals (n = 1115) enrolled in the Continuous Observation of Smoking Subjects (COSMOS) lung cancer screening program. The overall accuracy, sensitivity, and specificity of the miR-Test are 74.9% (95% confidence interval [CI] = 72.2% to 77.6%), 77.8% (95% CI = 64.2% to 91.4%), and 74.8% (95% CI = 72.1% to 77.5%), respectively; the area under the curve is 0.85 (95% CI = 0.78 to 0.92). These results argue that the miR-Test might represent a useful tool for lung cancer screening in high-risk individuals.