Abstract
Background: Early detection of lung cancer (LC) is important opportunity for decreasing mortality. A target-FISH Lung Cancer Detection (LCD) test developed by BioView Ltd, under a license from MD Anderson Cancer Center, as a non-invasive diagnostic assay based on combine analysis of cytology and cytogenetic biomarkers of bronchial epithelial cells in sputum
Objective: Evaluate the performance of the LCD test for detection of numeric alterations at the 3p22.1 and 10q22.3 loci via fluorescence in situ hybridization (FISH) in induced sputum as an aid for initial diagnosis of subjects suspected of having lung cancer.
Methods: Induced sputum samples collected from subjects with 0.8-3 cm pulmonary nodule who were scheduled for a lung biopsy. The LCD Test integrates the expression of specific cytogenetic alteration within a selected population cells from induced sputum in conjugation with the imaging capabilities of the BioView Duet™ System.
Results: Samples from 47 patients in Sheba Medical were analyzed. Positive-concordance is 96.67% (29/30) for LC patients. The negative-concordance is 71% (12/17) including 8 patients which don't have a definitive diagnosis and are still under follow up. In one case a negative biopsy was reevaluated and was classified as positive after a positive LCD test.
Conclusions: Malignant lung cancer nodules can be detected non-invasively by a new technology by induced sputum via combination of morphology detection and FISH analysis. This approach has the potential to be utilized for high-risk cohorts especially with small nodules (8-20 mm) where the probability for LC is relatively low (18%).
- Copyright ©ERS 2015