Molecular and Diagnostic Classification of Non-Small Cell Lung Cancer From Fine Needle Aspirates

The goal of this study is to demonstrate the feasibility of using a novel, validated panel of
Non-Small Cell Lung Cancer (NSCLC) histology-predictive genes (the "A/S signature) as a
diagnostic tool for use with small-volume Fine Needle Aspirate (FNA) biopsies.

Objectives:

1. To establish FNA biopsy requirements for FNA-based subtype classification of NSCLC.

2. To define a "fixed statistical model" of histologic subtype prediction in NSCLC.

Study methods: To establish FNA biopsy requirements for gene expression-based subtype
classification of NSCLC, patients with presumed newly diagnosed NSCLC, where radiographic
studies and clinical description favor a probable diagnosis of NSCLC, will undergo FNA biopsy
according to current standard techniques . For this part of the study, approximately 40
biopsies of confirmed NSCLC will be collected for analysis.

To define a fixed statistical model of histologic subtype prediction in NSCLC, we will
prospectively collect 50 FNAs. These FNAs will represent Adenocarcinoma (AC) and Squamous
Cell Carcinoma (SCC) cases at a ratio of approximately 1:1. Additional cases of not otherwise
specified (NOS), should they be encountered, may also be collected for later analysis. FNA
samples qualified based on cell number or ribonucleic acid (RNA) yield (depending on the
findings of our primary objective)will be assayed on the QGS platform.