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. 2015 Mar 18;17(1):41. doi: 10.1186/s13058-015-0543-x

Table 2.

Concordance of HERmark with local HER2 IHC, central HER2 IHC, local HER2 FISH, and local clinical HER2 status

Local HER2 IHC Central HER2 IHC Local HER2 FISH Local clinical HER2 status
Negative Equivocal Positive Total IHC Negative Equivocal Positive Total IHC Non-amplified Amplified Total FISH Negative Equivocal Positive Total HER2
N % N % N % N % N % N % N % N % N % N % N % N % N % N % N %
HERmark Negative 69 71% 14 14% 14 14% 97 51% 86 86% 13 13% 1 1% 100 52% 27 90% 3 10% 30 45% 83 83% 1 1% 16 16% 100 52%
HERmark Equivocal 10 38% 9 35% 7 27% 26 14% 17 71% 5 21% 2 8% 24 13% 11 92% 1 8% 12 18% 17 65% 0 0% 9 35% 26 13%
HERmark Positive 9 13% 7 10% 52 76% 68 36% 4 6% 23 34% 41 60% 68 35% 5 20% 20 80% 25 37% 10 15% 0 0% 58 85% 68 35%
Total 88 46% 30 16% 73 38% 191 100% 107 56% 41 21% 44 23% 192 100% 43 64% 24 36% 67 100% 110 57% 1 1% 83 43% 194 100%
Overall concordance 68%, (69 + 9 + 52)/191 69%, (86 + 5 + 41)/192 NA# 73%, (83 + 0 + 58)/194
Kappa (CI 95%), overall 0.475 (0.373 to 0.578); weighted Kappa = 0.545 0.481 (0.386 to 0.576); weighted Kappa = 0.631 0.510 (0.409 to 0.610); weighted Kappa = 0.583
Concordance, excluding Eqv.* 84%, (69 + 52)/(69 + 9 + 14 + 52) 96%, (86 + 41)/(86 + 4 + 1 + 41) 85%, (27 + 20)/(27 + 5 + 3 + 20) 84%, (83 + 58)/(83 + 10 + 16 + 58)
Kappa (CI 95%), excluding Eqv. 0.676 (0.550 to 0.797) 0.914 (0.841 to 0.988) 0.705 (0.516 to 0.893) 0.682 (0.570 to 0.794)

*Equivocal (Eqv.) cases from both tests were excluded; #NA, overall concordance was not calculated for 2 x 3 table. Central HER2 IHC retesting was performed retrospectively and central HER2 status was defined per ASCO/CAP guidelines for HER2 testing [7]. The results of local HER2 testing were reported by participating study sites based on local IHC and/or local FISH. Percentages may not add up to 100% due to rounding. CI, confidence interval; FISH, fluorescence in situ hybridization; HER2, human epidermal growth factor receptor 2; IHC, immunohistochemistry.