Noninvasive 3d Analysis of Sputum Cells for Lung Cancer Early Detection with High Specificity: A Blinded Study.

e18527 Background: The LuCED test for lung cancer early detection analyzes non-invasive sputum using the Cell-CT system that images cells in true 3D to measure the biosignatures of cancer. Morphometric classifiers process the 3D cell biosignatures to distinguish normal cells from abnormal cell candidates. A pathologist using the CellGazer workstation views images of these abnormal cell candidates to determine the diagnosis. Prior work demonstrated LuCED case sensitivity to early stage lung cancer of 95% with 99.8% cell specificity. This study offers a blinded assessment of LuCED’s clinical performance. Methods: 19 cases were studied: 7 normal cases and 12 biopsy-confirmed non-small cell and small cell lung cancer cases. 9 cancer cases were stage I or II. The remaining 3 late stage cancer cases had tumor sizes that were less than three 3cm. When an abnormal case is detected, typically more than one abnormal cell is involved so only cases with 2 or more abnormal cells were included as LuCED positives. Cases were randomized and all cell review was done in a blinded fashion so that the pathologist did not have access to the case diagnosis. Results: Normal cases: Cell –CT analysis identified 0.3% of 77,148 cells (or 99.7% cell specificity) as abnormal cell candidates. The 95% confidence interval for cell specificity is 99.66 to 99.74%. Pathologist review using CellGazer of the abnormal cell candidates produced zero false positive cells. The case specificity is 100%. Abnormal cells were detected by LuCED and confirmed by the pathologist in 11 of the 12 biopsy confirmed cancer cases. The case sensitivity is 91.7%. The missed case was a stage IB adenocarcinoma with a 4.5cm tumor occurring in the left upper lobe. Conclusions: This initial, blinded study of LuCED confirms earlier projections that LuCED sensitivity to early lung cancer exceeds 90% while maintaining exceedingly high specificity. This performance suggests an important role for the non-invasive LuCED test as an adjunct to Low dose CT screening, to dramatically reduce the inherent false positives and confirm positive diagnoses.