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MINI 12 - Biomarkers and Lung Nodule Management (ID 109)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Screening and Early Detection
- Presentations: 1
MINI12.04 - Blinded Evaluation of the LuCED test to Detect Early Stage Lung Cancer (ID 869)
16:45 - 18:15 | Author(s): J. Hayenga
A previous, non-blinded study presented at the American Society of Cytopathology demonstrated performance of the LuCED[®] test for early detection of lung cancer and showed a sensitivity to cancer of 93.6% with 100% specificity based on 94 patients. Sensitivity was consistent across tumor histology, stage, size and location. Here, LuCED performance is presented where the pathologist was blinded to the case diagnosis. Data for this evaluation was produced as part of the CLIA validation of LuCED for use in the VisionGate Biosignatures Laboratory.
Sputum from 42 patients was processed by LuCED: 23 patients had biopsy-confirmed lung cancer and 19 patients were normal. Sputum was collected from three spontaneous morning coughs, fixed and stained with hematoxylin, and enriched for epithelial cells using fluorescence activated cell sorting. Each enriched specimen was analyzed using the Cell-CT® platform that computes 3D digital images of single cells through tomographic reconstruction with isometric, sub-micron resolution. 3D morphometric biosignatures were automatically measured to produce a probabilistic score that identified abnormal cell candidates while a second score identified normal bronchial epithelial cells to determine specimen adequacy. Specimen adequacy was achieved when either abnormal cells were detected or 800 normal bronchial epithelial cells were enumerated by the classifier, whichever came first. Data was randomized by case and cell images of abnormal candidates were viewed using a CellGazer® workstation for blinded, cytopathologist confirmation. Cases were run until one of the following conditions was met: an abnormal cell was discovered, the specimen was exhausted, the criterion for specimen adequacy was reached. Example images of positive cells are shown in Figure 1. Figure 1
For cancer cases, lung cancer histology included adenocarcinoma (10 cases), squamous cancer (7), small cell lung cancer (3) and undifferentiated cancer (3); representing TNM stages I (5), II (10), IV (5), and unknown (3). Abnormal cells were found in all 23 cancer cases for 100% case sensitivity (lower 95% CI bound: 85.1%). Non-cancer lung diseases may produce reparative changes whose morphology can mimic cancer cell features. To stress test LuCED, patients with COPD, bronchitis, etc., were included in the normal group. 100,645 cells were processed from the 19 normal cases with 0.47% identified by the classifier for review using CellGazer. No abnormal cells were found. Case specificity is 100% (lower 95% CI bound: 82.4%).
This interim blinded study of LuCED performance demonstrates highly sensitive (100%) and specific (100%) early lung cancer detection suggesting utility as a non-invasive screening test.
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