Ανοσοϊστοχημεία

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. 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 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 all 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).

☑ 20 Test

☑ IVDR

The IQFISH panels include a set of oligonucleotide-based ready-to-use FISH probes, premixed with IQFISH hybridization buffer, for the detection of gene rearrangements and for the detection of gene amplifications by fluorescence in situ hybridization (FISH) on formalin-fixed, paraffin-embedded (FFPE) tissue sections. The probes consist of two child probes (3’ and 5’ probes), each designed to target a given gene and each labeled in a different color (orange-red Cy3 and green FITC).

The assays combine two ground-breaking technologies: oligonucleotide-based SureFISH technology and the formamide-free IQFISH hybridization buffer. SureFISH technology enables chromosomal aberration detection using a precise, synthetic oligonucleotide probe design process. IQFISH hybridization buffer is a unique, ultra-fast hybridization technology that allows probe hybridization to be performed in just 1-2 hours and provides complete FISH results in about 4 hours. Together these advancements provide fast, high-quality FISH results.

IQFISH Fast Hybridization Buffer is a formamide-free hybridization buffer that enables ISH hybridization to be completed in 1-1.5 hours. A complete in situ hybridization (ISH) assay on a formalin-fixed, paraffin-embedded (FFPE) sample can be completed in 4 hours enabling a half day sample-to-result workflow. This workflow offers many operation advantages such as increased turnaround time, same day repeat testing without impacting the quality of hybridization.

Standard formamide-based FISH hybridization buffer lowers the melting temperature of nucleic acids by targeting hydrogen bonds and interfering with DNA base pairing resulting in the denaturation of the DNA double strand. The interference slows down the following base pairing between the FISH probe and specimen DNA. However, IQFISH buffer destabilizes the DNA helix by diminishing hydrophobic base stacking (1). Minimized based paring interference enables fast binding between the ISH probe and specimen DNA.

IQFISH buffer is provided in three different size formats to meet the needs of varying testing volumes.

☑ 900 μL

☑ IVDR