CISH pharmDx Kit is a dual color chromogenic assay designed to quantitatively determine HER2
gene amplifications in formalin-fixed, paraffin-embedded breast cancer tissue specimens using bright field microscopy. Gene amplification is determined from the ratio between the number of signals from the visualization of the HER2
gene probe (red signals) and the number of signals from the reference chromosome 17 probe (blue signals).HER2
CISH pharmDx Kit is indicated as an aid in the assessment of patients for whom Herceptin® treatment is being considered. Results from the HER2
CISH pharmDx are intended for use as an adjunct to the information currently used for estimating prognosis in stage II, node-positive breast cancer patients.HER2
CISH pharmDx Kit is a complete system providing all reagents required to perform 20 CISH assays. This includes pre-treatment reagents, HER2
and reference chromosome 17 probe mix, peroxidase mix, CISH antibody mix, red and blue chromogens, substrate buffers and mounting media. A standard validated procedure and validated interpretation manual are also provided.HER2
CISH pharmDx Kit, Code SK109, is CE marked and FDA approved.