HER2 FISH pharmDx™ Kit is a direct fluorescence in situ hybridization (FISH) assay designed to quantitatively determine HER2 gene amplification in formalin-fixed, paraffin-embedded (FFPE) breast cancer tissue specimens and FFPE specimens from patients with adenocarcinoma of the stomach, including gastro-esophageal junction. HER2 FISH pharmDx™ Kit with the indication adenocarcinoma of the stomach, including the gastro-esophageal junction, is not available in selected markets. Gene amplification is determined from the ratio between the number of signals from the hybridization of the HER2 gene probe (red signals) and the number of signals from the hybridization of the CEN-17 reference chromosome 17 probe (green signals).

HER2 FISH pharmDx™ Kit is indicated as an aid in the assessment of patients for whom Herceptin™ treatment is being considered. Results from the HER2 FISH pharmDx™ Kit are intended for use as an adjunct to the information currently used for estimating prognosis in stage II, node-positive breast cancer patients.

HER2 FISH pharmDx™ Kit is a complete system providing all reagents required to perform 20 FISH assays. This includes pre-treatment reagents, HER2 and CEN-17 reference chromosome 17 probe mix, buffers and mounting medium. A standard validated procedure and validated interpretation guidelines are also provided.

HER2 FISH pharmDx™ Kit, Code K5331, is FDA approved.