TEST:

HER2 IQFISH pharmDx

HER2 IQFISH pharmDx is a direct fluorescence in situ hybridization (FISH) assay based on Dako's new fast IQISH hybridization buffer chemistry. The IQISH hybridization buffer is non-toxic and allows genomic DNA probe hybridization to be performed in just 60-120 minutes. HER2 IQFISH pharmDx is designed to quantitatively determine HER2 gene amplification in formalin-fixed, paraffin-embedded (FFPE) breast cancer tissue specimens and FFPE specimens from patients with metastatic gastric or gastroesophageal junction adenocarcinoma. 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). It is is indicated as an aid in the assessment of breast and gastric patients for whom Herceptin® treatment is being considered and for breast cancer patients for whom PERJETA™ or KADCYLA™ treatment is being considered (see Herceptin®, PERJETA™, and KADCYLA™ package inserts).