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.

Results from the TOP2A IQFISH pharmDx™ are intended for use as an adjunct to existing clinical and pathological information.

The DBCG 89D/TOP2A study (1, 2) has demonstrated significant prognostic value of TOP2A gene amplifications and deletions. Based on the comparisons to HER2 status it can be concluded that the HER2 status and TOP2A status are not interchangeable for the prognostic value. The presence of predictive implications from TOP2A amplifications for optimal use of anthracycline-containing therapy is an area of active research with promising initial results (1-5) that require confirmation and extension in a context of currently available chemotherapeutic options. Whether TOP2A amplification is an independent predictive marker of response to any type of treatment (chemotherapy or immune-based) remains to be established.

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