VisionGate Presents at the World Conference on Lung Cancer for 2023 in Singapore: PneuVision® Sputum Test for Lung Cancer Detects True Abnormal Cells in Non-cancer Patients with Near 100% Specificity
True Abnormal Cells in Normal Cases Detected by the PneuVision Test for Early-Stage Lung Cancer
Author Block: M.G. Meyer, A. Nelson
VisionGate, Woodinville/WA/USA
Abstract:
Introduction: The PneuVision test was developed to detect early-stage NSCLC using sputum. The Cell-CT platform analyzes the cells in 3D, with sub-
micron, isometric resolution that eliminates perspective bias inherent in 2D imaging. Highly accurate (aROC=0.991) classifiers were trained through a
machine-learning process to detect cells with features of aytipa+. Cytologists examined this small group of cells. A positive PneuVision test occurs when at
least one detected abnormal cell is confirmed cytologically. Because sputum has a high intra- and inter-patient variability, the analysis is normalized by the
enumeration of normal bronchial epithelial cells (BECs) automatically detected by classifiers in the Cell-CT. Not surprisingly, cancer detection sensitivity
increases with the BEC count and exceeds 90% for early-stage lung cancer. As a corollary, we focus here on the rate of positive tests among two groups of
normal patients.
Methods: A false positive occurs when a normal cell is indicated as abnormal during manual cytology review. Dysplasia is found in approximately 50% of
normal patients with diseases like COPD. Therefore, specificity is best estimated in cases without risk factors for dysplasia. Accordingly, the subjects studied
here are those without (N=34) and with (N=67) diseases such as COPD or emphysema for a total of 101 cases overall. Analyzing these groups supports the
following hypothesis: Low positive rate for the normal group without diseases implies high specificity and, as a correlate, the detection of abnormal cells in
the group with pulmonary diseases is primarily due to the detection of true abnormal cells from pre-cancer lesions.
Results: Abnormal cells were not found in normal cases without diseases, indicating that the Cell-CT classification, and cytology processes are robust and
stable and not prone to overcalling normal cells as abnormal cells. Abnormal cells were detected in normal cases with diseases like COPD and emphysema.
Conclusions: The specificity of the PneuVision test is nearly perfect. Abnormal cell discovery for cases with diseases such as COPD and emphysema are from
pre-cancer lesions.
Conclusions: Sensitivity increases as more cells from the bronchial epithelium are processed, and sensitivity increases more rapidly for squamous cell carcinoma than for adenocarcinoma. In practice, if the sensitivity for adenocarcinoma were set at an acceptible level, then the sensitivity to squamous cell carcinoma would exceed that level.
