Agilent Technologies Introduces IQFISH FFPE Buffer, Enabling One-Hour Hybridization of FFPE Tissue Samples

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. 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.

TOP2A 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. TOP2A IQFISH pharmDx™ is designed to detect amplifications and deletions (copy number changes) of the TOP2A gene using fluorescence in situ hybridization (FISH) technique on formalin-fixed, paraffin-embedded human breast cancer tissue specimens.Deletions and amplifications of the TOP2A gene serve as markers for poor prognosis in high-risk breast cancer patients. TOP2A gene amplification detected by the TOP2A IQFISH pharmDx™ is further indicated as an aid to predict recurrence-free and overall survival in high-risk breast cancer patients treated with adjuvant epirubicin-based chemotherapy. Results from the TOP2A IQFISH pharmDx™ are intended for use as an adjunct to existing clinical and pathological information. Topoisomerase IIα is a key enzyme involved in DNA replication and is the molecular target for topoisomerase II inhibitor therapies. Clinical research shows that the TOP2A gene can be used as a predictive indicator of susceptibility or resistance to anthracycline therapies.