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  P3.04 - Poster Session/ Biology, Pathology, and Molecular Testing (ID 235)

  • Event: WCLC 2015
  • Type: Poster
  • Track: Biology, Pathology, and Molecular Testing
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)

  • 15466

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    P3.04-084 - Analytical Validation of a Proliferation-Based Molecular Signature Used as a Prognostic Marker in Early Stage Lung Adenocarcinoma (ID 1716)

    09:30 - 09:30  |  Author(s): S. Wagner
    • Abstract
    • Slides

    Background:
    We have developed a gene expression signature that provides prognostic information for patients with early stage lung adenocarcinoma that would benefit from adjuvant chemotherapy. This signature uses quantitative reverse transcription PCR to measure RNA expression of 31 cell-cycle progression (CCP) genes normalized to 15 housekeeping genes to provide a quantitative CCP score. The signature can identify aggressive early stage tumors that might be suitable for post-surgical therapy. The aim of these studies was to validate the analytical performance of the CCP gene signature.
    
    Methods:
    The analytical performance of the CCP gene signature was evaluated using formalin-fixed, paraffin-embedded lung resections by assessing parameters such as precision, dynamic range, and RNA input requirements.
    
    Results:
    The signature had a standard deviation (SD) of 0.06 score units, which is 1% of the clinical range of scores. The dynamic range of CCP scores in this signature was from -13 and 14 score units. The average amplicon efficiencies for target and housekeeper genes were comparable at 107% and 105%, respectively. All but one amplicon had a SD <0.5 CT. The gene signature reproducibly generated a consistent CCP score with RNA input concentrations between 0.12 and 62.5 ng/μL, which is considerably larger than the concentration ranges used for clinical testing (2–40 ng/μL).
    
    Conclusion:
    These studies demonstrate that the gene signature is robust and reproducible, making it suitable for use in a clinical setting.
    
    

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