This document addresses gene expression classification for the diagnostic evaluation of lung cancer in individuals with suspected lung cancer following identification of pulmonary lesions on computed tomography (CT) scans. One commercially available test, the Percepta^® Bronchial Genomic Classifier, evaluates the expression of 23 genes in bronchial brushing samples taken during bronchoscopy. The intention of the test is to improve the diagnostic performance of bronchoscopy and reduce the need for invasive diagnostic procedures.

Please refer to the documents indicated below for information regarding screening for lung cancer and managing pulmonary nodules:

• ADMIN.00002 Preventive Health Guidelines
• LAB.00011 Selected Protein Biomarker Algorithmic Assays

Position Statement

Investigational and Not Medically Necessary:

The use of bronchial gene expression classification for the diagnostic evaluation of lung cancer in individuals with pulmonary lesions is considered investigational and not medically necessary.