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

Biomark Med. 2015;9(9):901-10. doi: 10.2217/bmm.15.46. Epub 2015 Jul 9.

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.

Keywords: FFPE; analytical validation; cell cycle progression; early-stage lung adenocarcinoma; gene expression; quantitative RT-PCR.

Publication types

  • Validation Study

MeSH terms

  • Adenocarcinoma / diagnosis*
  • Adenocarcinoma / genetics*
  • Adenocarcinoma / pathology
  • Adenocarcinoma of Lung
  • Biomarkers, Tumor / genetics*
  • Cell Cycle / genetics
  • Cell Proliferation / genetics
  • Gene Expression Profiling*
  • Genes, Neoplasm / genetics*
  • Humans
  • Linear Models
  • Lung Neoplasms / diagnosis*
  • Lung Neoplasms / genetics*
  • Lung Neoplasms / pathology
  • Neoplasm Staging
  • Prognosis
  • RNA Stability

Substances

  • Biomarkers, Tumor