Raising the Bar in the Diagnosis of Non-Small Cell Lung Cancer (NSCLC): The Impact of Automated FISH Technology

Purpose: The MET gene, which encodes a receptor tyrosine kinase, is crucial in cancer cell proliferation and survival. Fluorescence in situ hybridization (FISH) is vital for assessing MET-gene amplification in non-small cell lung cancer (NSCLC). Manual FISH assays are time-consuming, and results are critical for treatment decisions; automation could reduce turnaround time. This study evaluates the potential benefits of the automated FISH-system, Oncore Pro X (Biocare Medical USA), by assessing factors including results, turnaround time, and cost.
Materials and Methods: A method comparison was conducted using 20 NSCLC formalin fixed paraffin embedded (FFPE) specimens. Manual FISH-assays (ZytoLight® FISH-Tissue Implementation Kit with ZytoLight® SPEC MET/CEN 7 Dual Color Probe) were compared to automated assays (Oncore Pro X with MET (7q31) Orange + Copy Control 7 Green Probe). Concordance of MET-parameters was evaluated for both categorical and numerical data.
Results: Categorical data showed 80% concordance with a Cohen’s Kappa coefficient (k=0.86), indicating near-perfect agreement. A Bland-Altman plot for numerical data revealed no noteworthy bias. A radar chart based on scoring (0-5) of relevant categories rated the manual assay at 15 and the automated at 21 out of 25.
Discussion/Conclusion: The automated assay reduced turnaround time, allowing for faster treatment initiation. Despite minor discrepancies, the high concordance indicates that the Oncore Pro X system has strong potential to replace manual FISH in clinical settings, significantly reducing turnaround time. Future research should focus on expanding probe availability and further cost optimization.