HER2 IQFISH pharmDx™ is a direct fluorescence in situ hybridization (FISH) assay based on Dako's new fast IQISH hybridization buffer chemistry. The new IQISH hybridization buffer is non-toxic and allows genomic DNA probe hybridization to be performed in just 60-120 minutes. The short hybridization time results in a turnaround time of about 3½ hours for a complete FISH staining from deparaffinization to mounting.

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 adenocarcinoma of the stomach, including gastroesophageal junction. HER2 IQFISH pharmDx™ with the indication adenocarcinoma of the stomach, including the gastroesophageal 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 IQFISH pharmDx™ is indicated as an aid in the assessment of patients for whom Herceptin™ treatment is being considered. Results from the HER2 IQFISH 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 IQFISH pharmDx™ 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 in IQISH hybridization buffer, buffers and mounting medium. A standard validated procedure and validated interpretation guidelines are also provided.