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Table 4 Cross tabulation of HER2 gene status for CISH versus PathVysion FISH.

From: Dual color chromogenic in situ hybridization for determination of HER2 status in breast cancer: a large comparative study to current state of the art fluorescence in situ hybridization

  

PathVysion HER-2 FISH

 
  

Non-amplified

Amplified

Total

HER2 CISH pharmDx™

Non-amplified

302

4

306

 

Amplified

4

40

44

 

Total

306

44

350

  1. Two tailed 95% confidence intervals are based on the binomial distribution. Overall agreement: (342/350 × 100) = 97.7% (CI95: 95.7%; 98.9%), Positive agreement: (40/44 × 100) = 90.9% (CI95: 79.8%; 96.9%), Negative agreement: (302/306 × 100) = 98.7% (CI95: 96.9%; 99.6%) and Kappa: 0.90 (SE: 0.04)