Interlaboratory Comparison of HER-2 Oncogene Amplification as Detected by Chromogenic and Fluorescence in situ Hybridization

摘要: Purpose: Chromogenic in situ hybridization (CISH) is a new modification of the fluorescence (FISH) technique for detection oncogene amplification archival tumor samples. In CISH, probe detected using peroxidase reaction, allowing use transmitted light microscopy. We compared HER-2 / neu by CISH with Food and Drug Administration-approved two-color FISH test an interlaboratory setting. Experimental Design: Formalin-fixed paraffin-embedded samples from 197 breast cancers were analyzed CISH. Two-color (PathVysion) 17 centromere was done if observer considered it necessary to ascertain status tumors borderline copy numbers. Results: Paired CISH/FISH results available 192 (97%) cases, no clear difference success rates either method observed. Centromere seven tumors. concordant 180 cases (93.8%). There 92 88 found amplified nonamplified, respectively, both methods. Eight but not FISH, four exhibited opposite condition (kappa coefficient 0.875). 7 12 differences between two methods could have related lack chromosome information. The remaining explained difficult histology (ductal carcinoma , poor representativity, dense lymphocytic infiltration, or intratumoral heterogeneity). Conclusions: These indicate that provide accurate practical alternative clinical diagnosis HER-2/neu formalin-fixed cancer