HER2 IQFISH pharmDx (Dako Omnis)
HER2 IQFISH pharmDx (Dako Omnis) is, together with accessory reagent devices, 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.
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 (Dako Omnis) is indicated in adjunction to HercepTest in the assessment of patients for whom Herceptin™ (trastuzumab) treatment is being considered.
For breast cancer patients, results from HER2 IQFISH pharmDx (Dako Omnis) are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients.
HER2 IQFISH pharmDx (Dako Omnis), Code GM333, is CE marked.