TOP2A IQFISH pharmDx

TOP2A 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 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 (1-3).