LAUSR

Simple Summary Lung cancer is the most common cause of cancer-related deaths globally. Patients diagnosed at early-stage (0–I) have a higher survival rate than the metastasized stages (III–IV). Thus, there is great potential to reduce mortality by diagnosing lung cancer at stage 0~I through community screening. LDCT is a promising method, but it has a high false-positive rate. Therefore, a biomarker test that can be used in combination with LDCT for lung cancer screening to reduce false-positive rates is highly awaited. The present study evaluated the applicability of 9G testTM Cancer/Lung test to detect stage 0~IV lung cancer. 9G testTM Cancer/Lung test detects stage I, stage II, stage III, and stage IV cancers with the sensitivities of 77.5%, 78.1%, 67.4%, and 33.3%, respectively, at the specificity of 97.3%. These results indicate that the 9G testTM Cancer/Lung can be used in conjunction with LDCT to screen lung cancer. Abstract A complimentary biomarker test that can be used in combination with LDCT for lung cancer screening is highly desirable to improve the diagnostic capacity of LDCT and reduce the false-positive rates. Most importantly, the stage I lung cancer detection rate can be dramatically increased by the simultaneous use of a biomarker test with LDCT. The present study was conducted to evaluate 9G testTM Cancer/Lung’s sensitivity and specificity in detecting Stage 0~IV lung cancer. The obtained results indicate that the 9G testTM Cancer/Lung can detect lung cancer with overall sensitivity and specificity of 75.0% (69.1~80.3) and 97.3% (95.0~98.8), respectively. The detection of stage I, stage II, stage III, and stage IV cancers with sensitivities of 77.5%, 78.1%, 67.4%, and 33.3%, respectively, at the specificity of 97.3% have never been reported before. The receiver operating characteristic curve analysis allowed us to determine the population-weighted AUC of 0.93 (95% CI, 0.91–0.95). These results indicate that the 9G testTM Cancer/Lung can be used in conjunction with LDCT to screen lung cancer. Furthermore, obtained results indicate that the use of 9G testTM Cancer/Lung with LDCT for lung cancer screening can increase stage I cancer detection, which is crucial to improve the currently low 5-year survival rates.