Analytical validation of a proliferation-based molecular signature used as a prognostic marker in early stage lung adenocarcinoma.

ABSTRACT

AIMS: The aim of these studies was to validate the analytical performance of a cell cycle progression (CCP) gene signature that provides prognostic information for early stage lung adenocarcinomas. MATERIALS & METHODS: Formalin-fixed paraffin-embedded (FFPE) lung resections were evaluated by quantitative RT-PCR for the expression of 31 target and 15 housekeeper genes comprising the CCP score. RESULTS: The signature had a standard deviation (SD) of 0.06 score units and a dynamic range spanning CCP scores between -13 and 14. The average amplicon efficiencies for target and housekeeper genes were 107% and 105%, respectively. All but one amplicon had a SD <0.5 CT. CONCLUSION: These studies demonstrate that the gene signature is robust and reproducible, making it suitable for use in a clinical setting.