Biomoda, Inc.

Primary Objective:
* To determine the clinical sensitivity and specificity of the Biomoda CyPath™ Early Lung Cancer Detection Assay using sputum specimens from two cohorts of participants and estimate the required sample size to finalize a protocol for a pivotal study.
Secondary Objectives:
* To assess the capability of the Biomoda CyPath™ Early Lung Cancer Detection Assay in a clinical setting to identify cancer cells, as assessed by TCPP labeled cancer cells demonstrating red fluorescence under a microscope with ultraviolet (UV) light being observed with a FITC (Fluorescein isothiocyanate) Filter.
* To assess the capability of the Biomoda CyPath™ Early Lung Cancer Detection Assay to detect pre-invasive cancer in comparison with PAP sputum cytology and routine CT scan.