Table 1 Overview about HER2 fluorescence in situ hybridization thresholds for dual-color assays assessing HER2 and CEP17 gene copy number
PathVysion package insert | ASCO/CAP 2007 (ref. 9) | ASCO/CAP 2013 (ref. 10) | |
|---|---|---|---|
HER2 gene amplification | HER2/CEP17 ratio ≥2.0 | HER2/CEP17 ratio >2.2 | HER2/CEP17≥2.0 or HER2/CEP17<2.0 and mean HER2 gene copy number ≥6.0 |
Equivocal | Not applicable | HER2/CEP17 ratio of 1.8–2.2 | HER2/CEP17<2.0 and mean HER2 gene copy number ≥4.0 and<6.0 |
No HER2 gene amplification | HER2/CEP17<2.0 | HER2/CEP17 ratio <1.8 | HER2/CEP17<2.0 and mean HER2 gene copy number <4.0 |
