Analytical Performance of a 15-Gene Prognostic Assay for Early-Stage Non-Small-Cell Lung Carcinoma Using...

Area of Science:

• Oncology
• Molecular Diagnostics
• Genomics

Background:

• A 15-gene prognostic signature for early-stage non-small-cell lung carcinoma (NSCLC) has been clinically validated.
• The original assay used fresh-frozen tissue, necessitating evaluation of alternative formats for operational efficiency.

Purpose of the Study:

• To assess the performance and analytical validity of the 15-gene prognostic signature assay using RNA-stabilized tissue.
• To determine the concordance between RNA-stabilized and fresh-frozen tissue formats for NSCLC prognosis.

Main Methods:

• Comparative analysis of the 15-gene signature assay using matched fresh-frozen and RNA-stabilized NSCLC tissue samples.
• Analytical validation including concordance with a reference laboratory, lower limit of quantitation, assay reportable range, and precision studies.
• Assessment of assay robustness against potential contaminants like genomic DNA.

Main Results:

• The percent concordance between RNA-stabilized and fresh-frozen tissue formats was 84%, comparable to the assay's inherent reproducibility.
• The clinical laboratory achieved 94% concordance with a reference laboratory, with no evidence of bias.
• The assay demonstrated high reproducibility, repeatability, and robustness, with a confirmed lower limit of quantitation and defined reportable range.

Conclusions:

• The 15-gene prognostic signature assay is suitable for use with RNA-stabilized tissue.
• RNA-stabilized tissue provides a viable alternative format, enabling operational efficiencies without compromising assay reliability for NSCLC prognostication.