HER2 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 FDA approved.