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HER2 IQFISH pharmDx (Dako Omnis)

HER2 IQFISH pharmDx (Dako Omnis) is the hybridization probe for the automated direct fluorescence in situ hybridization (FISH) assay onboard Dako Omnis instruments. It consists of a HER2 and CEN-17 probe mix in IQISH hybridization buffer and is provided in a ready-to-use vial for the Dako Omnis instrument. The IQISH hybridization buffer is non-toxic and allows genomic DNA probe hybridization to be performed in just 75 minutes on the Dako Omnis instrument. The short hybridization time results in a turnaround time of less than 4 hours for a complete FISH staining from deparaffinization to mounting.

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.

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