HER2 FISH pharmDx
Wednesday 7 December 2011
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.
The correlation between dual-color chromogenic in situ hybridization and fluorescence in situ hybridization in assessing HER2 gene amplification in breast cancer. Pedersen M, Rasmussen BB. Diagn Mol Pathol. 2009 Jun;18(2):96-102. PMID: #19430295#