Comparison of GP and PathVysion FISH assays in measuring HER2 gene status in breast cancer

Abstract

：Objective To evaluateclinical application of Jin Pujia GP HER2 probe kit in testing HER2 gene status of breastcancer through comparing it with PathVysion HER2 probe kit. Methods HER2 gene status weredetected from 108 cases with invasive ductal breast cancer using GP and PathVysion HER2probe kits by FISH. HER2 gene expression levels were measured by GP and PathVysion HER2probe kits, and the sensitivity, the specificity and the accuracy of GP HER2 probe kitwere evaluated. Results HER2 gene amplification positive rates detected by GP HER2 probekit and PathVysion HER2 probe kit were 25.0%(27/108) and 26.9% (29/108), respectively. Ascompared with PathVysion HER2 probe kit, the sensitivity, the specificity and the accuracyof the GP HER2 kit were 89. 7% (26/29), 98.7% (78/79)and 96. 3% ( 104/108), respectively,whereas the PPV and NPV were 96. 3% (26/27) and 96. 3% (78/81), respectively. The GP HER2probe kit had a sensitivity of 93.3% ( 14/15), a specificity of 100%(93/93) and anaccuracy of 99. 1% (107/108) for detecting polysomy 17. Conclusion GP HER2 probe kit hashigh sensitivity and specificity for detecting HER2 gene status in breast cancer patients,and it has clinical application value.