All of the following are FDA-approved for In Situ testing:
PathVysion HER-2 DNA Probe Kit - Abbott Molecular United States (Des Plaines, Illinois)
Fluorescence in situ hybridization (FISH) assay was used to determine HER2 amplification using the locus-specific HER2 probe, which spans the HER2 gene, and the centromere 17 probe, which hybridizes to the alpha satellite DNA located at the centromere of the chromosome.
HER2 FISH pharmDx™ Kit - Agilent Dako Corporate Headquarters (Glostrup, Denmark)
The FISH assay was used to determine HER2 gene amplification in formalin-fixed paraffin-embedded (FFPE) breast cancer specimens.